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Author Topic: Actifit in treating meniscal tears  (Read 23357 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.