Can a plastic implant replace a torn knee meniscus?
NCT ID NCT01712191
First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time
Summary
This trial tests a device called the NUsurface Meniscus Implant for people with a damaged or removed meniscus in the knee. The implant is designed to act like a natural meniscus, cushioning the knee and reducing pain. Researchers will measure changes in knee pain and function using a standard score called KOOS. The study includes adults aged 35 to 75 who have a degenerative or torn meniscus, or who have had part of their meniscus removed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NUsurface Meniscus Implant, a medical device designed to replace a damaged or removed meniscus in the knee
- What this could lead to
- If it works, this implant could offer a new way to treat knee pain and disability from meniscus damage, potentially delaying or avoiding knee replacement surgery.
- What could go wrong
- This is an early, non-randomized study, so results may not hold up in larger trials. The implant requires surgery, and risks include infection, implant failure, or the need for additional procedures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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128 people
The number who actually took part.
- Started
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Jan 2011
- Finished
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Mar 2016
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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35 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI. 2. Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal. 3. Be in neutral alignment +/- 5 degrees of the mechanical axis. 4. Be between age 35 and 75 at the time of the planned surgery. 5. Be able to be fitted anatomically with a size 30 to 90 NUsurface® device. 6. Have a normal mental status. 7. Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule. 8. Be able and willing to understand and sign the informed consent form. Exclusion Criteria: 1. Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant 2. Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s) 3. Have a varus or valgus knee deformity \> 5 degrees. 4. Have a laxity level of more than II (ICRS), secondary to previous injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL). 5. Have patella instability or non-anatomically positioned patella 6. Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB). 7. Need a tibial osteotomy at the time of surgery. 8. Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device 9. Have any type of previously implanted prosthetic meniscus or ligament or knee implant made of plastic. 10. Have a knee flexion contracture \> 10 degrees 11. Be unable to flex the knee to 90 degrees 12. Have a leg length discrepancy causing a noticeable limp. 13. Have had a previous major knee condyle surgery 14. Present with insufficiency fractures or avascular necrosis of the medial compartment. 15. Have an active infection or tumor. 16. Have any type of knee joint inflammatory disease including Sjogren's syndrome. 17. Have neuropathic knee osteoarthropathy, also known as Charcot joint. 18. Have any medical condition that does not allow arthroscopy at the point of entry to the knee. 19. Be pregnant or is a female intending to become pregnant during the study period. 20. Be mentally incapacitated. 21. Be a prisoner. 22. Be a patient who has economic incentive not to improve (e.g., workman's compensation patient) 23. Be morbidly Obese (BMI \> 35). 24. Is unwilling or unable to have an X-ray, Fluro, or MRI of the affected knee
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Monica
Antwerp, Belgium
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Assaf Harofeh Medical Center
Ẕerifin, Israel
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Emek Medical Center
Afula, Israel
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Ghent University Hospital
Ghent, Belgium
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Maastricht University Medical Centre
Maastricht, Netherlands
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Sacro Cuore- Don Calabria Hospital
Negrar, Italy
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Sahlgrenska universitetssjukhuset
Gothenburg, 41345, Sweden
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Sporthopaedicum Berlin
Berlin, Germany
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Tel Aviv Sourasky Medical Center- Ichilov
Tel Aviv, 64239, Israel
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UniKlinikum Regensburg
Regensburg, Germany
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Other studies related to the condition(s) this trial covers.
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- Can a plastic meniscus implant keep knees Pain-Free for years?