CompletedNot Applicable

Treatment of the Medial Meniscus With the NUsurface(R) Meniscus Implant

Belgium, Germany, Israel128 participantsStarted 2011-01

Plain-language summary

This is a prospective, multi-center, open label, non-randomized study, evaluating the treating of medial meniscus deficiency with the NUsurface Meniscus Implant.

Who can participate

Age range35 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have a degenerative and/or torn meniscus and/or previous meniscectomy as confirmed by diagnostic MRI.
✓. Have a pain score of 75 or less on the KOOS pain scale, with 100 being normal.
✓. Be in neutral alignment +/- 5 degrees of the mechanical axis.
✓. Be between age 35 and 75 at the time of the planned surgery.
✓. Be able to be fitted anatomically with a size 30 to 90 NUsurface® device.
✓. Have a normal mental status.
✓. Be willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule.
✓. Be able and willing to understand and sign the informed consent form.

Exclusion criteria

✕. Have evidence of a Grade IV articular cartilage loss on the medial tibial plateau or femoral condyle that could contact the NUsurface implant
✕. Have lateral compartment pain with lateral articular cartilage damage greater than Grade II (OB), and/or a lateral meniscus tear(s)
✕. Have a varus or valgus knee deformity \> 5 degrees.
✕. 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).
✕. Have patella instability or non-anatomically positioned patella
✕. Have patellar compartment pain and/or patellar articular cartilage damage greater than Grade II (OB).
✕. Need a tibial osteotomy at the time of surgery.
✕. Have an ACL reconstruction performed less than 9 months before implanting the NUsurface® device

What they're measuring

Knee injury and Osteoarthritis Outcome Score (KOOS)

Timeframe: 24 Months

Trial details

NCT IDNCT01712191

SponsorActive Implants

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Meniscus; Degeneration trials