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Author Topic: Actifit in treating meniscal tears  (Read 22662 times)

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Offline JuhaH

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Actifit in treating meniscal tears
« on: August 30, 2010, 02:08:07 PM »
Hi there,

I would like to understand more about Orteq's Actifit and trying to find answers listed below. Have You found any answers?

1. I would highly appreciate possibility to read the European Clinical Study published in July 2008 by Orteq, Based on this study Actifit was granted CE-mark and sales permission in Europe.  If you also have alternative studies available about Actifit implant, I would be very interested in reviewing them.

Answer: Results from patient´s two years follow-up are going to be presented in Barcelona at the end of September. I have also short publications, i.e “preliminary data” presentations and congress posters that I can send to you and discuss about them with you.

2.  What  kind of reaction does patient´s immune response have to elements of Actifit implant (polyurethane)?  How do the white blood cells react when patient´s knee is confronted with new material? Is it likely that the white blood cells start to repel the polyurethane implant? 

Answer: We have tissue samples of over forty patients. Samples have been taken one year after Actifit implantation. Results show that there is nothing to observe, which means that patients´ body has not reacted in any way to Actifit material.


3.  I have learned to understand that all substances have their own features, and when the molecules scatter, these features can alter.  For example new substance can be acidic and the PH-value declines. I´m wondering if the PH-value of polyurethane implant converts to acidic? And can this process (alteration to acidic) result in the recess of knee cartilage?

Answer: We already have over 3 years follow-up from some patients, and over forty patients´ MRI-pictures. These samples show that there is no evidence of damage to cartilage.  We have three patients, whose cartilage has recoverd and two patients, whose knee joint reclining has gotten worse.  But these patients´ starting situation was already severe, and they had difficult arthrosis, when the Actifit was implanted.  All the other patients have non-altered status of cartilage.

4. Is there a possibility that the degrading substance of the implant is harmful to the knee cartilage? Is there any clinical approval that implant is secure to patient?

Answer: The longest follow-up we have at the moment is during the period of 3 years. We haven´t been able to detect any problems with all those over 300 patients that we have treated with Actifit implant.

5.  What kind of long-term research results there is of patients that are treated with Actifit implant? What is these patients´condition today? What is the praxis of the duration of the implant after the surgery? What is the average length of permanence of the implant in patient´s knee i.e how long does it take to implant thoroughly recess in the knee?

Answer: Our results are based on MRI-pictures and patients´ reaction to pain and ability to use the knee. Actifit is supposed to recess in patient´s body, and in theory it is going to eliminate from the knee in around 5-6 years. As the longest follow-up we have at the moment is for 3 years, I cannot comment on this matter at the moment.

6. Furthermore I would be very interested in knowing that what is the impact that generates the process where the remains of the meniscus are activated to rebuild with the Actifit implant?

Answer: Actifit implant consists of 80% air and 20% material.  The material used is spongy and all the porouses are connected to each other. This enables the cells to adhere to Actifit material and therefore grow and produce the material that surrounds the cells. Actifit acts as a support environment.  We have clear proofs that blood veins from outer zone of medial meniscus will grow inside the Actifit and therefore bring material for the growth. It is although a fact that blood veins don´t grow in any particular space, if there is no cells that “invite” blood veins. Therefore we suggest that the original cells probably come from joint fluid, which fills the Actifit. Remember that Actifit is like a sponge, it absorbs liquids and other particles.

If I have understood correctly, the meniscus doesn´t build up when it has been treated in a way, that significant part(s) of it has been removed.

Answer: This is correct. There is no environment for the cells to grab on and therefore give support to the new tissue during the period when it´s growing.  The most important issue is that there needs to be connection to the blood vessel system, because there is no blood veins in the third innermost part of the meniscus. In the middle part of meniscus there is few blood veins and in the outer part there is substantial amount of blood veins.

Thanks in advance for any replies.

Read Here introduction, basic science and indications for use. I collected here additional documentation about Actifit scaffold.
« Last Edit: February 07, 2011, 11:12:59 AM by JuhaH »
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #1 on: August 31, 2010, 11:54:52 AM »
There exist undeniably no serious clinical studies about Orteqs Actifit. Some weeks ago, I analyzed and summarized presented data concerning this new polyurethane meniscus implant in this forum.  It is wholly unacceptable that all my critical statements were removed by the KNEEGuru moderator caused by external pressure from the manufacturers of Actifit.

 “Defamation is a false and unprivileged statement of fact that is harmful to someone's reputation, and published "with fault," meaning as a result of negligence or malice.”  (http://www.eff.org/issues/bloggers/legal/liability/defamation)

All my comments were verifiable, well documented by diverse sources and had nothing to do with defamation. It is a typical behavior that manufacturers don’t want to publish critical results of their products and always threaten to take vigorous legal steps. Business is business. But from a patient point of view it is necessary to unearth the truth.

It is a verified fact that all my mentioned surgeons [edited by KNEEguru] stand traceable on Orteqs (colleague lists) [edited] (www.orteq.com Surgical Advisory Board or European Clinical Investigators). They (are involved in) [edited] Actifit lectures, instructor activities and consulting activities, etc. But on the other hand these surgeons don’t want to dispute about existing critical facts. That's not very sporting!

It is not my province to check copyright infringements. But even if videos and photos of Actifit re-arthroscopies were filmed illegally on medical congresses, where is the problem concerning the data content? Why are the manufacturers highly interested to shroud these presented visual evidences? It is the sense and purpose of all published data that everybody can use it and verify it. [some content edited out] So let us face the facts again. The determined study protocol, the study procedure itself and first and foremost all results of the multi-centre trial are more and more subject to criticism:
•   7 protocol violations
•   27 of 46 ongoing patients showed substantial extrusions that means external displacements of Actifit implant
•   allegedly no serious adverse events, but definitely 5 device removals (quite a few explantations outside of European trial as well)
•   one illegal corrective (second) implantation after the rupture of a lateral Actifit
•   min. 31 of 52 study patients was operated in just two centers (Gent and Kiel): 60% of all results are generated by two surgeons with commercial interest. This has absolutely nothing to do with a serious multicenter trial (9 European study centers)
•   low level of evidence: single-arm, no controlled, no randomized trial with a small number of patients

Furthermore conclusions of animal studies were amongst others: No significant defect filling and no prevention of cartilage degeneration (Russel Warren et al. New York Hospital, NY 2009 = ovine model) and Actifit is not recommended for human clinical use (Roy T.C. Welsing et al. 2008 = dog model).

It is verified and has been established that Actifit patients show extrusions based on the stiff polyurethane implant accompanied by joint pain and inflammation. Investigators constitute this negative secondary effect as a standard outcome in meniscus replacement therapy. But this is awful nonsense. The few available re-arthroscopies show a marginal integration of the extraordinary polyurethane matrix one year postimplantation and substantiate no biological tissue regeneration. The implant has changed to a strange and morbid yellow artificial device, which was never documented postoperative in meniscus scaffolds based on a collagen matrix. Nobody knows what happens with the discolored aliphatic polyurethane. It seems almost incredible but the clinical degradation rate of polyurethane was never approved by a serious feasibility study.    

Of course some patients – all with preoperative pain - did profit by this polyurethane implant as a plastic antishock pad with unknown durability and unknown biocompatibility. But there exist many patients who did not. This sad reality is documented on YouTube. As a patient I would exercise restraint. All that glistens is not gold.


Pencille, this is interesting. Are you Actifit already Actifit patient? Or are you searching more information how to treat you're torn meniscus like I am?

I have one more question. How is it possible that Orteq has completed enrolment in its European clinical trial if Actifit is not functioning at all? I'm just trying to understand how medical device companies such as Orteq are approved for sale in Europe and what sort of clinical data they have to present?
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline WestPoint

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Re: Actifit in treating meniscal tears
« Reply #2 on: September 01, 2010, 04:46:17 AM »
This product looks identical to Menaflex, but how do their results compare with each other?

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #3 on: September 01, 2010, 01:06:58 PM »
Westpoint,  both products (Menaflex and Actifit) are indicated for segmental tissue loss, and not complete meniscal replacement. Check out this handout about meniscal implants.

I haven't found yet comparison about Actifit and Menaflex. Probably there isn't enough clinical studies about these two implants.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline WestPoint

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Re: Actifit in treating meniscal tears
« Reply #4 on: September 01, 2010, 07:49:36 PM »
Juha,

You're right that we are not able to clinically compare the two. However, besides the FDA problem, Menaflex does not have the 'issues' surrounding it that Actifit does, which would make me feel a bit more comfortable with Menaflex.


Offline Pencille

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Re: Actifit in treating meniscal tears
« Reply #5 on: September 01, 2010, 11:44:05 PM »
As a well-informed surgeon I know that it is easy to get a CE mark in Europe, showing that a new device isn’t harmful and reasonably safe. You don’t have to demonstrate long term quality or evidence based data of your device. Actifit got CE label with 10 patients and follow up of one year. Manufactures and speakers are not interested to release precise details of European multicenter trial that uncommitted person can prove inconsistencies.

Nobody can answer your questions regarding immune response, degradation rate and long term research results etc. Reputable literature isn’t available and there exist only one patient population (not randomized, not controlled). For that reason all findings approach from one and the same source. Simplest way to get newest research data (without opportunity of verification) is to attend lectures: 2yr Actifit clinical result lectures at SICOT in Gothenburg, AGA in Vienna, ICRS in Barcelona, London knee meeting, Bone-tec in Hannover, SIGASCOT in Verona and Hosmote in Oslo.

Menaflex implant is based on a biological matrix of collagen type 1 like origin meniscus tissue and various published literature attest a natural meniscus tissue regeneration and the gain for meniscus patients.  Against it Actifit matrix simply consists of polyurethane with unknown degradation rate, unknown durability and unknown biocompatibility and no independent publications. You cannot compare apples and oranges.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #6 on: September 06, 2010, 12:21:08 PM »
Hi,

Pencille, I understand that both meniscal implants (Menaflex and Actifit) are very    relatively new ways how to treat meniscal tears. I think too that 2 year clinical result doesn't yet prove long term results. In the other hand, due to the pain and swell I feel more or less crippled. The fact is that I don't have any decent options how to treat my knee. What would you do in my situation? If Actifit would give me even 2-3 painless years I would probably go for it.

I called to Orteq and asked my questions. They have been very helpful and answered to them. I just added answers below my questions with red color.
Orteq also did send me many articles and documentation about Actifit and meniscus implants. I can share them if you're interested to read those.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline Joost

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Re: Actifit in treating meniscal tears
« Reply #7 on: September 06, 2010, 08:38:54 PM »
Hi Juha.,

I also had issues with my knee after menisectomy. I have to a degree gotten on a better track throgh he following:

- prolotherapy injections
- taking herbal supplements as Cissus RX and greenlip mussel
- Yoga ( Iyengyar)

How long have you had the injury. I am now 1 1/2 yrs post op. Ypou have to take time.


Best rgds,

Joost

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #8 on: September 09, 2010, 08:49:50 AM »
Hi,

Joost, I'm now 9 months post op. Here's couple of new pics from my knee. I have joint space narrowing in my knee's medial side and that is causing the pain. What did you decided? Did you went to the Actifit treatment? I have some medial meniscus left so I'm good candidate for Actifit treatment. I haven't decided yet what I'm going to do.

Personally I agree what Pencille is telling us. It's way too early to say what happens in long term. On the other hand I think it's great that Orteq and Regen are at least trying to do something and researching for a solution how to repair our damaged meniscus. I really hope that one day they have evidence and long term clinical studies how to repair our meniscus's hurting knee's.

I'm going to get prolotherapy injections as soon as I have time.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline Pencille

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Re: Actifit in treating meniscal tears
« Reply #9 on: September 16, 2010, 01:07:56 PM »
 Hi JuhaH,

Thanks for asking but I already know all posters, articles and detailed documentation about Actifit.

Possibly all these findings sound good for a complete layman. But if you see behind the curtain the company isn’t able to issue new evidenced scientific data. It's always the same story of a biased trial in conjunction with marketing-oriented articles and empty promises of proponents. Sadly just some improvements of scores and suspect MRIs which show artificial polyurethane without any incorporation of new tissue. Of course Actifit is easy to implant for every unskilled surgeon but I believe this argument is irrelevant as far as clinical outcome is unconvincingly. Beside the tissue samples, Orteq has more than forty videos one year after implantation as well. Ever wonder why no video is publicly accessible?

You can't be too careful these days. If I were in your shoes, I would look for a surgeon who is experienced with the low-risk collagen implant.  In order to be always on the safe side collagen matrix verifiably resorbs residue-free within two years and will be substituted in the majority of cases by a body’s own tissue. Results are at least equally to Actifit I would even go so far as to say that a collagen meniscus is more advantageous. Reliable experienced data and literature reviews more than a decade of clinical use.

Offline WestPoint

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Re: Actifit in treating meniscal tears
« Reply #10 on: September 17, 2010, 02:45:44 PM »
Pencille,

You seem very strongly in favour of Menaflex, which is fine, but I find it interesting that you have only posted here about this subject. That is not to say that your points are not valid; just very pointed.

Would it be possible for you to lead us to the non-biased studies that have been conducted on Menaflex, or any other colagen implants?

Thanks.

Offline Pencille

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Re: Actifit in treating meniscal tears
« Reply #11 on: September 17, 2010, 11:43:05 PM »
Hi WestPoint,

You are absolutely right. I get involved in this topic when I have noticed increasing noncritical use of this polyurethane implant despite there is absolutely no evidenced data available. On top of this I don’t like the way as this immature meniscus implant has been pushed by investigational surgeons who have a beneficial and commercial interest in this product above all. A sophomoric Belgian Professor promises 100% success of Actifit but in my opinion he suffers loss of reality. He is still in denial about extrusions and explantations which are unjustifiable. In my opiion the European multicenter trial of Actifit is almost useless.

Colleagues and I prefer Collagen Meniscus Implants because of valid clinical data and pursuant experiences over the last 15 years. Our success rate is roughly 75 per cent. Of course it is not a 100% guarantee of tissue regrowth but CMI respectively Menaflex is a good-natured implant. If substitutions fail it doesn’t harm pretty much because Menaflex resorbs completely.  Here is some literature based on manufacturers information:

Bulgheroni  P. et al. (2010) Follow-up of Collagen Meniscus Implant patients: Clinical, radiological, and magnetic resonance imaging results at 5 years. Knee. 2010 Jun: 17(3):224-229. ----  Rodkey WG et al  (2010) Menaflex Collagen Meniscus Implant: Basic Science. In: Beaufils P, Verdonk R, eds. The Meniscus. Springer-Verlag Berlin Heidelberg, Chapter 11.1: pp 367-371, 2010 ---- Monllau JC et al (2010) Collagen Meniscus Implant: Technique and Results. In: Beaufils P, Verdonk R, eds. The Meniscus. Springer-Verlag Berlin Heidelberg, Chapter 11.2: pp 373-382, 2010 ---- Zaffagnini  et al. (2009) Synthetic Meniscal Scaffolds. Techniques in Knee Surgery 8 (4): 251-256, Dec 2009. ----Rodkey WG et al. (2008) Comparison of the Collagen Meniscus Implant with Partial Meniscectomy. A Prospective Randomized Trial. J Bone Joint Surg Am. 90:1413-1426, 2008. ----Genovese et al.  (2007) Follow-up of collagen meniscus implants by MRI. Radiol Med 112 (7): 1036-1048, 2007---- Buma P et al. (2007) The Collagen Meniscus Implant. Expert Rev Med Devices. Jul; 4(4):507-516, 2007 ---- Zaffagnini S et al. (2007) Arthroscopic collagen meniscus implant results at 6 to 8 years follow up. Knee Surg Sports Traumatol. Arthrosc. 15 (2):175-183, 2007 ----Linke RD et al (2006) Replacement of the Meniscus with a Collagen Implant (CMI). Oper Orthop Traumatol. Dec;18(5-6):453-62, 2006 ---- Ronga M et al (2006) Tissue Engineering Techniques for the Treatment of a Complex Knee Injury. Arthroscopy, 22(5): 576.e1-576.e3, 2006 ----  Martinek et al. (2006): Second generation of meniscus transplantation: in-vivo study with tissue engineered meniscus replacement. Arch Orthop Trauma Surg '126(4): 228-34, 2006 ---- Reguzzoni M et al (2005) Histology and ultrastructure of a tissue engineered collagen meniscus before and after implantation. J Biomed Mater Res B Appl Biomater. 74B:808-16, 2005 ---- Steadman et al (2005) Tissue-engineered collagen meniscus implants: 5- to 6-year feasibility study results. Arthroscopy 21(5):515-25, 2005 ---- Müller-Rath R et al (2004) Meniscus Replacement: Current Aspects in Tissue Engineering. Z Orthop, 2004; 142: 540-545 ---- Ronga M et al (2003) Short-term evaluation of collagen meniscus implants by MRI and morphological analysis. J Orthopaed Traumatol 4:5-10, 2003 ---- Steadman et al (2000) The Collagen Meniscus Implant: Development and clinical trials of a device to treat meniscus injuries of the knee. Sport Orthop Traumatol 16,4:173-177, 2000 ---- Rodkey WG et al (1999) Collagen scaffolds: A new method to preserve and restore the severely injured meniscus. Sports Medicine and Arthroscopy Review 7:63-73, 1999 ---- Rodkey WG et al (1999)  A clinical study of collagen meniscus implants to restore the injured meniscus. Clin Orthop Relat Res 367S:281-92, 1999 ---- Stone KR et al (1997) Regeneration of meniscal cartilage with use of a collagen scaffold. Analysis of preliminary data. J Bone Joint Surg 79-A (12):1770-1777, 1997 ---- Stone KR et al (1995) Autogenous replacement of the meniscus cartilage: analysis of results and mechanisms of failure. Arthroscopy 11(4):395-400, 1995. ----  Rodkey WG et al (1993) Replacement of the irreparably injured meniscus. Sports Medicine and Arthroscopy Review

Offline Kaputt_Knee

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Re: Actifit in treating meniscal tears
« Reply #12 on: September 18, 2010, 08:44:22 AM »
Pencille,

Quote
A sophomoric Belgian Professor promises 100% success of Actifit but in my opinion he suffers loss of reality. He is still in denial about extrusions and explantations which are unjustifiable. In my opiion the European multicenter trial of Actifit is almost useless.

I believe it is time that you actually came clean and declare what your interest is.

I've been reading this thread amongst others you have posted on and bit my lip when you were derogatory about the CE Mark for medical devices. However, your further dismissal of all things apparently European are making you look xenophobic [some content edited out by KNEEguru].

The awarding of the CE mark in the medical field is neither easy, nor is it of lesser value than the approval of the FDA. Both are exceptionally hard to obtain and do require considerable testing and documented development information among other things, that the general public do not even begin to understand nor see. It does not take years for any of the awards, for sure, but detailed accounts of all trials, tests and independent evaluations from external and respected specialists are involved. It is also an on-going process and the approval can be withdrawn if the claims or quality are compromised in any way. As I work in this field as a translator (Regulatory Affairs) I know only too well what is involved in the submission for these awards/approvals and also that it is not "given away" It is a sign of proven excellence as well as quality. In my opinion and experience, the CE mark can be superior to that of the FDA as the awarding body is less influenced by the interests of any one nation's pharmaceutical industry because it is a cross-border multi-national and therefore neutral recognition of excellence.

I and any other member could claim to be nuclear physicists or the best orthos in the world if we so desired. You imply that you are a renown surgeon in this field. This is the internet we could claim to be who the heck we like and who can nay-say us, no-one.  However this site has HonCode status of which the site owner is justifiably proud. This means that there are clear instructions about medical professionals registering.

Here's the link in case you did not have time to read them:

http://www.kneeguru.co.uk/KNEEtalk/index.php?topic=48577.0

This is the relevant section that you appear to have failed to read.

Quote
All users are by default considered as non medical professionals. If otherwise, to retain our HONcode status you must state this. If a health professional gives medical information as a platform user, his/her status as a medical professional must be identified. Information on the bulletin board and the rest of the site is not meant to replace the advice of a health professional. Content is designed to complement, not replace, the relationship between a patient and his/her own physician.

Your claim to be a medical professional:

Quote
Colleagues and I prefer Collagen Meniscus Implants because of valid clinical data and pursuant experiences over the last 15 years. Our success rate is roughly 75 per cent. Of course it is not a 100% guarantee of tissue regrowth but CMI respectively Menaflex is a good-natured implant. If substitutions fail it doesn’t harm pretty much because Menaflex resorbs completely.

So what are your credentials? And more importantly, what is your interest in denigrating one procedure in favour of another?

Sue

« Last Edit: September 18, 2010, 10:42:26 AM by The KNEEguru »
1989 big trauma R. knee - sorted
1990-2004 3ACL recons and 20+ arthroscopies -RK
3/06 LK ACL torn!
4/06 ACL recon, kneecap broken
09 &10/06- 2x meniscus trims
3/07 - Notch Plastic & Lateral Release
14/8/08 complete revision ACL plus LCL/PLC recon
6/2/09 returned to skiing! Whoopee

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #13 on: October 10, 2010, 09:25:26 PM »
Hi!

Orteq has released Actifit 2 year clinical results summary. Read summary here. Histology results of
1 year biopsies shows that Actifit scaffold is really helping new tissue re-population in meniscus. This was interesting and I would like to read the whole clinical study. Have you seen the study?
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #14 on: October 17, 2010, 01:41:59 PM »
FDA released more news about Menaflex scaffold -> http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm229384.htm .
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline WestPoint

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Re: Actifit in treating meniscal tears
« Reply #15 on: November 06, 2010, 11:19:08 PM »
Hi Juha,

What have you decided to do with your meniscal tear?


Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #16 on: November 08, 2010, 10:51:39 AM »
Hi West,

Right now I'm fighting against my insurance company, (IF insurance). IF insurance claim's that I have had disease based degeneration before skiing accident and that has caused my medial meniscus tear. I have newer had any problems before skiing accident in my lower-limbs. How can I prove to insurance company that my meniscus was destroyed in skiing accident in January 2010?

Actifit surgery costs about 5000 € here in Finland and I really need payment obligation from insurance company.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline Evilannie

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Re: Actifit in treating meniscal tears
« Reply #17 on: January 10, 2011, 04:10:49 PM »
Sue


The awarding of the CE mark in the medical field is neither easy, nor is it of lesser value than the approval of the FDA. Both are exceptionally hard to obtain and do require considerable testing and documented development information among other things, that the general public do not even begin to understand nor see.

I work for a medical device company also, and completely agree with you.   The amount of work that goes into proving the safety and efficacy of a medical device before even attempting to apply for a CE mark is immense. 

Pencille, as for the CE mark being easier to obtain than FDA approval...the 510(k) process in itself is often used to gain approval in the US so companies can gain enough supportive clinical data to apply for a CE mark.  The EU wont even look at you if you don't have extensive clinical data (whereas if you prove equivalence to an already approved product, you do not always need to provide clinical data for the US), and as such, i personally have always viewed the CE mark as the more challenging approval process.
Its only after we have lost everything, that we are free to do anything.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #18 on: March 07, 2011, 03:29:25 PM »
Hi,

Actifit treatment is now available in public health care to all patients for free, here in Finland too. I'm scheduled for my Actifit surgery in 21st of March surgery here in Helsinki. First Actifit surgery (lateral meniscus) was done in Helsinki 8 weeks ago. My ortho surgeon said yesterday, that concerned patient is feeling fine and he is pain free now.

Here's recap and summary about our treatment plan and forthcoming surgeries. I'm going under the knife soon, so here's sequence of events in chronological order listed below:

First stage. Surgery in 21st of March here in Helsinki. Research of damaged nerve fibers, receptors and attachment of Actifit implant in same surgery.

Second stage. Meniscus allograft transplant surgery in Belgium, Ghent. Allograft surgery is made by Rene or Peter Verdonk. Potentially some Finnish ortho surgeons would like to play a part in surgery to learn more about allograft transplant surgery.

Third stage. Total knee arthroplasty. This is last the resort and I will leave no stone unturned to prolong the total knee replacement.

About the first surgery 21st of March. My ortho surgeon is convinced that, without medial menisci, arthritis of articular cartilage will advance and increase in speed and destroying the left of my knee's articular cartilage. Because of the progressive devastation of the knee joint, we try to gain some time by attaching the Actifit implant in the same surgery with neural surgery.
I'm convinced that my constant neuropathic pain is caused by re-tear and damaged fibrocartilage and nerve tissues in the medial menisci posterior or anterior horns (or both). This has been really hard to prove to ortho surgeons, but I'm confident that we will find fresh ruptures in meniscus fibrocartilage inside the knee. We discussed yesterday with with my OS, and he agreed that sometimes meniscus cartilage tear is invisible in MRI-pictures.

About the second surgery. If and when Actifit implant fails for some reason, or Actifit implant melts away without new fibrocartilage in meniscus, or I cause re-tear to the implant or to the meniscus cartilage, then we will proceed to the meniscus allograft transplant from cadaver. Meniscus allograft transplant surgery is made by Rene or Peter Verdonk. I think that meniscus allograft transplant is technically demanding, high risk surgery and here in Finland, we don't yet have have any experienced allograft transplant surgeons. We talked this allograft transplant plan through with my ortho surgeon and we agreed that Verdonk (both Rene and Peter) are most experienced surgeons in Europe in the field of menisci allograft transplant know-how. So I require, that Verdonk is going to operate my allograft transplant surgery.

About the third stage, which is total knee replacement. This stage is a limiting factor in my life and unwanted situation in this age.

So probably I have many knee surgery's in the near future. But then again, I think that it is worth to fight tooth and nail, to reduce pain and slow down ultimate destruction of articular cartilage. Right?  :)

I'm still wondering here that what happens to the meniscus after Actifit implant is eliminated from the knee in 5-6 years? Another question is that what kind of cartilage is regrown meniscus inside Actifit scaffold? Is new meniscus like cartilage sufficiently long-lasting in daily use over the years?

What do you think? Comments from Actifit patients would be great too.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #19 on: March 21, 2011, 11:58:31 AM »
Hi,

Here is Actifit one year results published in the American Journal of sport Medicine. Study shows impressive results and Actifit is soon in US market too.

Results: Tissue ingrowth at 3 months was demonstrated on DCE-MRI in 35 of 43 (81.4%) patients. All but one 12-month secondlook (43 of 44 [97.7%]) showed integration of the scaffold with the native meniscus and all biopsy specimens (44) showed fully vital material, with no signs of cell death or necrosis. Three distinct layers were observed based on morphologic structure, vessel structure presence or absence, and extracellular matrix composition.
Conclusion: The DCE-MRI demonstrated successful early tissue ingrowth into the scaffold. The biopsy findings demonstrated the biocompatibility of the scaffold and ingrowth of tissue with particular histologic characteristics suggestive of meniscus-like tissue. In conclusion, these data show for the first time consistent regeneration of tissue when using an acellular polyurethane scaffold to treat irreparable partial meniscus tissue lesions.

Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #20 on: March 28, 2011, 11:41:21 AM »

Assume Actifit is Menaflex by another company? There is no guarantee for regrowth, and I think it is a fight between protecting the implant and rehabilitation of your knee.  Good luck with it.
Yes, there are now two types of implants designed to regenerate the meniscus when part of it has been removed: The Menaflex supplied by Hospital Innovations and the Actifit supplied by Orteq. Both act as scaffolds for new tissue to grow into and regenerate the healthy cushion. They are made of slightly different materials and both procedures have been reported to be successful in relieving pain after meniscectomy. However the long term benefit of reducing the severity of later arthritis in the knee is not yet fully clear as the technology has not been around long enough. If the whole meniscus has been removed then the scaffold synthetic substitute will not suffice and a meniscal allograft transplantation using a donor graft is indicated.
Menaflex is made from highly purified collagen and gets absorbed by the body by 12 – 18 months after implantation, after the bodies own cells have taken over and formed new strong tissue. Menaflex became available in Europe in early 2008. Information from the manufacturer details that more than 2000 Menaflex implants have been surgically implanted worldwide. Studies show that patients regain over 70% of their original meniscus tissue volume.
Actifit was developed in Belgium and is made from a polyurethane polymer and has a very similar appearance to the Menaflex. Laboratory and clinical studies indicate the scaffold may still be present 5 years after implantation giving the body longer time to form a new natural regenerated meniscus. Early clinical studies have shown good short time results for improved function and reduction in pain.

There has been no direct comparison between the these two implants to know which is better. On the other hand, Actifit seems to be more effective, because it absorbs slower (3-5 years) and gives the new meniscus more time to regrow inside the Actifit scaffold.

The implants are inserted at key-hole arthroscopic surgery which is usually a day case procedure. The incision to get the implant into the joint is about 2 – 3 cm long. Rehabilitation after surgery naturally has to be slow as the body has to grow tissue into the scaffold and this is a slow process. Full weight on the leg is allowed at 8 – 10 weeks and the specific rehabilitation program is tailored to each patient depending on the state of the knee surfaces and the amount of new meniscus inserted. Biopsy studies looking at the new tissue under the microscope have shown that the new tissue is fairly strong by 12 months.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline raffles

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Re: Actifit in treating meniscal tears
« Reply #21 on: March 05, 2012, 01:32:15 PM »
Hi Juha
           Apologies for posting under the meniscus implant topic.

            You have obviously looked in to the Actifit scaffold quite deeply and I am trying to work out what is the downside for me at nearly 50 , 25% meniscus since last May, giving this a try. The videos suggest pain is reduced and whilst long term data is not available common sense suggests arthritis may be delayed.
                                                                                                Thanks
                                                                                                           Mark

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #22 on: March 05, 2012, 02:19:02 PM »
Hi Juha
           Apologies for posting under the meniscus implant topic.

            You have obviously looked in to the Actifit scaffold quite deeply and I am trying to work out what is the downside for me at nearly 50 , 25% meniscus since last May, giving this a try. The videos suggest pain is reduced and whilst long term data is not available common sense suggests arthritis may be delayed.

Thanks Mark

Hi Mark,

I have had a long talks with my orthopedic surgeon about possible treatments in near future and we decided to proceed slowly and gradually. In my opinion there's no need to scamp to the next surgery and make things even worse. When I have more time I will make an appointment to the radiologist and get new X ray pictures of my knee. Development of arthritis can be seen on a knee x-ray when  surgeon compares x rays. If new x ray reveals that arthritis is advancing rapidly then we have to proceed to the Actifit surgery sooner.

My surgeon mention also that we might go for high tibial osteotomy. Based on the articles, replacing a knee in a patient who has had a prior tibial osteotomy may be slightly more difficult than performing a primary knee replacement, but is easier and achieves better results than redoing a knee replacement and is usually very successful.

Good luck with your knee and keep us posted.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline raffles

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Re: Actifit in treating meniscal tears
« Reply #23 on: March 05, 2012, 03:23:28 PM »
Hi Juha
           Thanks for your reply. You are rightly cautious about possibly making things worse - its just that the claims from the 2 year clinic trial are so seductive!
            At this stage I am asking myself whether the claims from the company are credible or not? I don't regard myself as an optimist, pessimist or a fool for that matter but I am inclined to believe them. The list of surgeons that they have trained up is impressive - you would have thought that they must all believe in it otherwise they would not want their reputations to be tarnished by association. There is also a tendency for patients to publicly vent their disappointment when things go wrong but quietly get on with their lives when things work out. I have not read about about anyones personal experience with Actifit which could be a good sign.
            I'll let you know if I decide to pursue it.
                                                                    Mark

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #24 on: March 06, 2012, 09:08:08 AM »
Hi Mark,

Personally I think that the company behind Actifit scaffold is doing great job by doing clinical research on this field of unmet medical need. At least someone in this world is trying to help patients who are living with nonfunctional knee joint and slow down the inevitable early osteoarthritis after meniscectomy. Then again it comes as no surprise, that it will take more than a decade before a long-term multi-center randomized clinical studies are being published.

If you are now considering Actifit treatment, Orteq has trained a number of orthopedic surgeons on the procedure in almost every country here in Europe. You might want to meet one of these orthopedics and discuss more about all the important treatment elements in your case. If you would like further advice, or would like to discuss about the Actifit can also contact directly Orteq by email or call them.


Good luck.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline Billy Freezer

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Re: Actifit in treating meniscal tears
« Reply #25 on: March 13, 2012, 08:56:02 PM »
Hey Juha,

I take it it's been almost a year since you had the actifet fitted?
How is your knee feeling?

I'm considering it. I need to have a partial menisectomy on my lateral meniscus. We don't know how much will be taken off until the surgeon actually looks inside, but I figured even if it were a small amount it couldn't hurt to have some sort of CMI.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #26 on: August 24, 2012, 09:46:04 PM »
Hi all,
I was recently inspired by this forum to venture to obtain the Actift knee implant, after injuring my knee last year, and rendering it almost useless.
I wanted to help provide information to anyone in a similar situation to myself and this is my story so far....
After a lifetime of being super-fit, at 44 years of age, and absolutely no health problems whatsoever, I slipped on a cable, while turning quickly, and felt a pop in my knee.
Initially, I thought it was just a sprain, but after 6 wks of limping about with a locking knee, I went to my GP, he tested positive Mcmurrays, and sent me to hospital. I was apparently 'lucky' because the surgery was empty, and they carried out a partial menisectomy on the same day, without first doing an MRI.
After 3 months of excruciating physiotherapy, my knee function had declined to the point where I couldn't walk on it at all, so with my insistence I was eventually referred for an MRI.
3 months later, the MRI revealed that my symptoms were due to 60% of my entire meniscus had sheared off, and needed removing. I went onto the waiting list for surgery, and waited for months, before I decided that going private was the only option for me.
I paid privately for the partial menisectomy to remove 60 percent of my medial meniscus, and following this surgery, I was told that my articular cartilage had been damaged (both Femur and patellar), and that damage had probably been incurred while trying to use the knee with a broken meniscus.
I nevertheless, optimistically awaited by recovery. It was n't long before I realised that the symptoms I was having were still almost exactly the same ie burning pain, joint laxity, catching.
I'd read about the Actifit meniscal  implant, and also the premature wear that the articular cartilage undergoes following menisectomy and decided to endeavour to obtain one.
I contacted Prof Peter Verdonk at the Ghent University Hospital in Belgium, and he arranged anr MRI, and consultation for me the following week. He determined that the Actifit meniscal implant was suitable for me because I was within the age range, I had an intact meniscal rim, and posterior and anterior meniscal horns, and in otherwise good health.
I had the Actifit meniscal implant successfully fitted, the following morning at a cost of £6000. The four days following the surgery, were quite painful, more so than the menisectomies that I'd had before, but after all, the surgery was a bit more intrusive. I'd had 2 internal sutures attaching the meniscal implant ends made arthroscopically, and 3 internal sutures that had been made externally through a one inch incision to hold the middle part of the implant. The implant length that was needed was 38mm.
All in all, there 3 small incisions for the arthroscope, internal sutures, and implant insertion, and these were sutured as well. I was also pleased to learn that I'd also had bone marrow aspirated and inserted within the knee capsule for stem cell healing, and Im hopeful that this will repair the articular surfaces, and the ligament laxity. After the surgery, my leg was wrapped in bandages and put into a cork leg case, immobilised for 5 days. I've been given a 6 month physio instruction manual, and so far I'm up to week 3. Its non-weightbearing for a total of 4 weeks and 5 days since surgery. I have to wear the Donjoy OA adjuster unloader brace to limit the flexion during the day, and locked at night. In a couple of weeks, I can change the settings on the brace to transfer my bodyweight onto the lateral compartment while the medial side is recovering, and this will allow me to walk again (Please note these unloader braces are not cheap - about £500). I can't emphasise enough, how awkward it is having a non-weightbearing leg, and I'd advise anyone considering the Actifit  to have a couple of days trial to prepare anything that can be foreseen to help with this stage.
 Its too early to say whether the Actifit implant has worked or not, all I can say is that I can do the excercises without pain, and the wounds have healed.
 I have an MRI and review that is due in 6 weeks to see whether I'm one of the 80% that has a good healing response. I'll give updates, as and when , or if anyone has questions feel free to ask.


Hi,

It would be great to hear more about your rehab during the autumn.

Good luck :)
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #27 on: August 31, 2012, 07:23:17 AM »
Partial replacement of the meniscus of the knee using a biodegradable scaffold. Read full NICE (The National Institute for Health and Clinical Excellence) guidance http://guidance.nice.org.uk/IPG430 .
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline JuhaH

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Re: Actifit in treating meniscal tears
« Reply #28 on: February 18, 2014, 03:58:06 PM »
Hey Juha,

I take it it's been almost a year since you had the actifet fitted?
How is your knee feeling?

I'm considering it. I need to have a partial menisectomy on my lateral meniscus. We don't know how much will be taken off until the surgeon actually looks inside, but I figured even if it were a small amount it couldn't hurt to have some sort of CMI.

Hi Billy,

Sorry for the late reply. Did you get the Actifit implantation?
Like I replied in 2012, we talked with my orthopedic surgeon about Actifit scaffold treatment and we decided to cancel the implantation surgery. Decreased pain in activities of my everyday life was the reason for cancelling the surgery.
Skiing accident in january 2010. Left knee, medial joint space narrowing and constant pain following partial meniscectomy (30% medial meniscus left). Trying to prolong the knee replacement as long as I can.

Offline Catherine88

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Re: Actifit in treating meniscal tears
« Reply #29 on: October 09, 2016, 09:00:23 PM »
Hi juha; how are You doing now?















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