Actifit® clinical results

The Actifit clinical study results are very encouraging and members of the Actifit clinical study group have presented the one and two year results to the medical community at numerous international Orthopedic congresses over last few years.

The one year clinical results have just been published in the American Journal of Sports medicine(March 2011).

American Journal of Sports Medicine, April 2012.
Succesful Treatment of Painful Irreparable Partial Meniscal Defects with a Polyurethane Scaffold. Two Year Safety and Clinical Outcomes. Click here to see the AJSM publication of Actifit two year results.

Orteq® Sports Medicine reports statistically and clinically significant pain reduction and functional improvement in the two year study results for its meniscal scaffold product Actifit®

Wednesday 29th September 2010: At the International Cartilage Repair Society (ICRS) congress, Sitges, Spain, Orteq® Sports Medicine (Orteq®), the private orthopaedic medical technology company, today reports statistically and clinically significant pain reduction and functional improvement in the two year clinical study results for Actifit®, its meniscal scaffold for the treatment of irreparable partial meniscal tears.

Meniscal tears are the most common injury of the knee, affecting at least 1.5 million people globally each year. In young patients, meniscal tears normally occur as a result of sports injuries, with the most common mechanism involving twisting on a loaded bent knee with the knee then giving way. The knee’s menisci are two half-moon, wedge shaped pieces of cartilage that act as a shock absorber distributing forces evenly between the femur (upper leg) and tibia (lower leg) in the knee joint.

Developed over the last two decades by leading polymer scientists and orthopaedic surgeons treating sports injuries, Actifit® is designed to help patients regain an active lifestyle after suffering a meniscal injury. The arthroscopically implanted polyurethane scaffold provides a temporary structure that supports the ingrowth of new tissue to replace the surgically removed damaged meniscal tissue. In time, Actifit® degrades and is replaced by new functional tissue with meniscus-like characteristics.

Professor Rene Verdonk, head of the Department of Orthopaedic Surgery and Traumatology at the University Hospital in Gent, Belgium, and lead investigator of the Actifit® EU study group*, gave his overall impression of the two year results:

“I am delighted with the two year results. Young patients previously hindered by pain have returned to pre-injury activity levels and can now enjoy a normal life having been treated with Actifit®. The product is safe and reliable, and we had a very low failure rate. It can be clearly seen securely in place on MRI at two years and the biopsies done of patients at one year showed there is consistent in-growth of vital new tissue in each biopsy. Actifit® appears to be the next generation solution for the treatment of painful irreparable partial meniscus tissue loss.”

Dr Eva-Lisa Heinrichs, Chief Medical Officer of Orteq® commented:

“The most exciting data from the study is related to the patients’ decreased pain at the same time function has increased. After a period of rehabilitation, patients can gradually increase their activity level and return to pre-injury activities. In fact, statistically significant improvements were seen in all clinical scores used in the study (VAS, IKDC, KOOS, and Lysholm), with the biggest improvement observed in pain reduction and in the KOOS subscales which assess return to sports and quality of life.”

“It has been great to work with the Actifit® Study Group, as well as the specialists in the Orthopaedic, Radiology and Cell Biology departments at the University Hospital of Gent, Belgium. Their expertise has been invaluable in completing and analysing the Actifit® EU clinical study

New Actifit® publications

The safety and short-term efficacy of a novel polyurethane meniscal scaffold for the  treatment of segmental medial meniscus deficiency.

Turgay Efe • Alan Getgood • Markus D. Schofer • Susanne Fuchs-Winkelmann • Dieter Mann • Jurgen R. J. Paletta • Thomas J. Heyse

Knee Surg Sports Traumatol Arthroscopy July 2011

http://link.springer.com/article/10.1007%2Fs00167-011-1779-3?LI=true

 

Meniscal scaffolds;  Early experience & review of the literature

Knee. March 2012

Spencer SJ, Saithna A, Carmont MR, Dhillon MS, Thompson P, Spalding T

http://www.thekneejournal.com/article/S0968-0160(12)00028-2/abstract

 

Biodegradable polyurethane meniscal scaffold for isolated partial lesions or as combined procedure for knees with multiple comorbidities: clinical results at 2 years.

Elizaveta Kon • Giuseppe Filardo • Stefano Zaffagnini • Alessandro Di Martino •Berardo Di Matteo • Giulio Maria Marcheggiani Muccioli •Maurizio Busacca • Maurilio Marcacci       

Knee Surgery Sports Traumatology Arthroscopy Nov 2012

http://link.springer.com/content/pdf/10.1007%2Fs00167-012-2328-4

 

Posters presented on Actifit® and the Actifit® polymer

Annual Meeting ORS 2008 Frictional Analysis and Tissue Changes in Interfaces of Cartilage and Joint Reconstruction Materials Gleghorn J.P.Bonassar L.J. S.B. Doty, T.M. Wright, S.A. Maher View poster
Annual Meeting ORS 2008 Dynamic Contact Mechanics of a Scaffold for Partial Meniscal Replacement Brophy R.H Maher, S.A.J. Cottrell, X Deng, T. Wright, S. Rodeo, R. Warren View poster
ESSKA 2008 Evaluation of a Meniscal Repair Scaffold in an Ovine Model Rodeo S.AR.H. Brophy, L. Ying, S.A. Turner, X.H. Deng, S.B. Doty, R. Sarrafian, T.M. Wright, S.A. Maher Warren R.F View poster
ASME Summer Bioengineering 2008 Boundary Mode Frictional Properties of Meniscal Repair Tissue Galley, N.KJ. Gleghorn, T. Wright, S. Doty, S. Maher Bonassar L.J View poster
ESSKA 2008 Imaging findings after meniscal repair with degradable polyurethane scaffold: Interim results Verdonk R W. Huijsse, F. Almqvist, P. Verdonk Verstraete K View poster
IMUKA 2009 Clinical efficacy and safety of a resorbable meniscus scaffold for the treatment of partial meniscal tear or meniscal loss P Verdonk, R Cugat, H Laprell, J Bellemans, P Djian, H Paessler, P Beaufils, P Colombet,Verdonk R. View poster
Annual Meeting ORS 2009 Boundary Mode Frictional Properties of Meniscal Repair Tissue Galley, N.K. Gleghorn, J.P. Wright, T.M., Rodeoe, S, Warren, R., Maher, S.Bonassar L.J. View poster
Annual Meeting ORS 2009 Evaluation of a Meniscal Repair Scaffold in an Ovine Model Maher, S.A. Doty, S.B., Rosenblatt, L., Rodeo, S.A. Brophy,R. Turner, A.S. Warren R.F click here to view poster
Bone-tec 2009 Implantation of a novel synthetic scaffold for meniscus tissue regeneration P. Verdonk W. Huysse, R. Forsyth Verdonk R. View poster
BESSKA 2010 Clinical Efficacy of a Novel, Synthetic Meniscus Scaffold for Treating Irreparable, Partial Meniscal Tissue Loss Verdonk R. P Verdonk, R Cugat, H Laprell, J Bellemans, P Djian, H Paessler, P Beaufils, P Colombet, View poster
Basel international knee conf 2011 Significant pain reduction and improved function following treatment of irreparable partial meniscus tears with a polyurethane scaffold, two year follow up. Verdonk R. P Verdonk, R Cugat, H Laprell, J Bellemans, P Djian, H Paessler, P Beaufils, P Colombet, View poster
Basel international knee conf 2011 Tissue ingrowth following implantation of a novel synthetic acellular meniscal scaffold for the treatment of irreparable partial meniscus tears and/or partial meniscal tissue loss Verdonk R. P Verdonk, R Cugat, H Laprell, J Bellemans, P Djian, H Paessler, P Beaufils, P Colombet, View poster