CompletedNot Applicable

Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects

Austria, Belgium, Israel143 participantsStarted 2014-05

Plain-language summary

Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.

Age range18 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.

✓. 18 years or older
✓. Up to 3 treatable cartilage lesions, ICRS IIIa - IVb on the femoral condyles or the trochlea,
✓. Symptomatic total treatable area 1-7 cm2. Asymptomatic lesions will not be included in the calculation
✓. KOOS Pain score at baseline is not less than 30 and not more than 65
✓. Must be physically and mentally willing and able to comply with post- operative rehabilitation protocol and scheduled clinical and radiographic visits.
✓. Informed consent signing

✕. Bony defect depth deeper than 8mm, according to imaging Articular cartilage lesions in the tibia or the patella, ICRS grades IVa and IVb
✕. Any previous ligamentous repair or malalignment correction in the index knee within the last 3 months
✕. Significant instability of the index knee according to IKDC Knee Examination Form 2000, Grade C (abnormal) or D (severely abnormal)
✕. Lack of functional remaining meniscus
✕. Meniscal transplantation in the past 6 months
✕. Malalignment more than 5 degrees varus OR 5 degrees valgus according to standing X-ray
✕. Any known tumor of the index knee
✕. Any know history of infection of the index knee

• The KOOS Pain Subscale relative to baseline

Timeframe: 24 Months

NCT IDNCT02423629

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-19