Chondral Lesion
Conditions
Interventions
Group 1: target patient group:
• One symptomatic knee with a cartilage defect on the medial
femoral condyle, lateral femoral condyle, or trochlea
• A single (after debridement), isolated cartilage d
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
21 Years to 55 Years
Inclusion criteria
Inclusion criteria: • Patients operated between the dates of 09/01/2021 and 09/01/2023 • Patients treated with microfracture plus Chondro-Gide • Chondro-Gide fixed with fibrin glue • One symptomatic knee with a cartilage defect on the medial femoral condyle, lateral femoral condyle, or trochlea identified through MRI or previous arthroscopy • Between 21 and 55 years of age • A single (after debridement), isolated cartilage defect classified as ICRS grade III or IV on the medial femoral condyle, lateral femoral condyle, or trochlea • Post-debridement defect size = 3 cm2 and < 8 cm2
Exclusion criteria
Exclusion criteria: • Prior surgical treatment of the index knee using microfracture, mosaicplasty, or autologous chondrocyte implantation (debridement and lavage are acceptable if the procedure was at least 3 months prior to the index surgery • Chronic inflammatory arthritis or infectious arthritis • History of autoimmune disease or immunodeficiency • History of connective tissue disease • Active infection of the index knee
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The endpoint will be the proportion of patients achieving the PASS at 24 months follow-up (range 21 to 30 months), with PASS defined as a patient meeting the 3 following criteria: 1. =72.2 value in the Pain subscale of the Knee Injury and Osteoarthritis Outcomes Score (KOOS) of at 24 months follow-up 2. =86.8 value in the Activities of Daily Living (ADL) subscale of the KOOS of at 24 months follow-up 3. Free from secondary surgical intervention related to the device, procedure, or treated lesion Since this endpoint includes two PASS criteria and free from surgical intervention related to the device, procedure, or treated lesion, it is also referred to as the Month 24 composite clinical success (CCS) endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be evaluated as secondary endpoints. 1. Achieving =71.5 value (PASS) in the Symptoms subscale of the KOOS of at 24 months follow-up 2. Achieving =43.8 value (PASS) of Sports and Recreation subscale of the KOOS of at 24 months follow-up 3. Achieving =50.0 value (PASS) in the quality-of-Life subscale (QoL) of the KOOS of at 24 months follow-up 4. Improvement in the Symptoms subscale of the KOOS of at least 8.3 points from baseline to 24 months follow-up 5. Improvement in the Sports and Recreation subscale of the KOOS of at least 15 points from baseline to 24 months follow-up 6. Improvement in the QoL subscale of the KOOS of at least 18 points from baseline to 24 months follow-up 7. Improvement in the Pain subscale of the KOOS of at least 11.1 points from baseline to 24 months follow-up 8. Improvement in the ADL subscale of the KOOS of at least 15 points from baseline to 24 months follow-up | — |
Countries
Germany
Contacts
Public ContactFabiana Martinelli
Geistlich Pharma AG
Outcome results
None listed