NCT02423629CompletedNot Applicable
Agili-C™ Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Smith & Nephew, Inc.
- Enrollment
- 143
- Locations
- 8
- Primary Endpoint
- • The KOOS Pain Subscale relative to baseline
Study Overview
Brief Summary
Evaluate the performance of the Agili-C™ in the repair of Cartilage and Osteochondral defects.
Detailed Description
Agili-C™ implant is a CE marked, bi-phasic, porous resorbable tissue regeneration scaffold for the treatment of articular cartilage and/or osteochondral defects.
The Agili-C™ implant will be implanted using the Agili-Kit™ surgical toolset which is designed for the precise preparation of sites in cartilage and osteochondral defects, for implanting the Agili-C™ implant
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 cm
- •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
Exclusion Criteria
- •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
- •Any known history of inflammatory arthropathy or crystal-deposition arthropathy
- •Any known systemic cartilage and/or bone disorder such as but not limited to chondrodysplasia or osteogenesis imperfecta
- •Body mass index >35
- •Osteoarthritis of the index knee graded as 4 according to the Kellgren- Lawrence scale
- •Chemotherapy treatment in the past 12 months
- •Any previous surgical cartilage treatment in the index knee within the last 6 months
- •History of allergic reaction or intolerance of materials containing calcium carbonate or hyaluronate
- •Patient who is pregnant or intends to become pregnant during the study
- •History of any significant systemic disease, such as but not limited to, HIV infection, hepatitis infection or HTLV infection; known coagulopathies, that might compromise the subject's welfare
- •Known substance abuse or alcohol abuse
- •Participation in other clinical trials within 30 days prior to the study or concurrent with the study
- •Known insulin dependent diabetes mellitus
- •Unable to undergo MRI or X-ray
Outcomes
Primary Outcomes
• The KOOS Pain Subscale relative to baseline
Time Frame: 24 Months
The KOOS pain subscale is evaluated at 6m, 12m, 18m \& 24m
Secondary Outcomes
- • Improvement in other KOOS subscales relative to baseline(24 Months)
- • Improvement in IKDC Subjective Knee Score relative to baseline(24 Months)
- • Improvement in SF-36 Survey(24 Months)
- • Improvement in Tegner Score(24 Months)
- • Improvement in Lysholm Knee Scoring Scale(24 Months)
- • Joint Space maintenance rate according to X-ray(24 Months)
- • Defect Fill according to MRI(24 Months)
- Improvement of Overall KOOS (average of all KOOS Subscales) relative to baseline(24 mMonths)
Investigators
Study Sites (8)
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