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The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microfracture | Active Comparator | Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair |
|
| Microfracture with Chondro-Gide sutured | Experimental | Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure |
|
| Microfracture with Chondro-Gide glued | Experimental | Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfracture | Procedure | Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot |
| Measure | Description | Time Frame |
|---|---|---|
| Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years | The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score | 2 years post-surgery |
| MRI (magnetic resonance imaging) assessment of structural repair parameters. | Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML). | 6 months and 1,2 and 5 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System. | The Change from Baseline will be evaluated. | 6 months and 1,2 and 5 years post-surgery |
| Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sven Anders, MD | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Regensburg | Bad Abbach | Germany | ||||
| Universitätsklinikum Freiburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23730377 | Result | Anders S, Volz M, Frick H, Gellissen J. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC(R)) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Open Orthop J. 2013 May 3;7:133-43. doi: 10.2174/1874325001307010133. Print 2013. | |
| 28108777 | Result | Volz M, Schaumburger J, Frick H, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop. 2017 Apr;41(4):797-804. doi: 10.1007/s00264-016-3391-0. Epub 2017 Jan 20. |
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|
| Chondro-Gide sutured | Device | Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy |
|
| Chondro-Gide glued | Device | Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy |
|
The Change from Baseline will be evaluated. |
| 6 months and 1,2 and 5 years post-surgery |
| Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package". | The Change from Baseline will be evaluated. | 6 months and 1,2 and 5 years post-surgery |
| Adverse Events (AE) Review | The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants. | 5 years post-surgery |
| Freiburg im Breisgau |
| Germany |
| Universitätsklinikum Giessen | Giessen | Germany |
| Orthopedikum Hamburg | Hamburg | Germany |
| Unfallklinik Hannover | Hanover | Germany |
| University of Schleswig-Holstein | Lübeck | Germany |
| Sportklinik Ravensburg | Ravensburg | Germany |
| 38630297 | Derived | Volz M, Schaumburger J, Gellissen J, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of autologous matrix-induced chondrogenesis (AMIC(R)) over microfracture: 10-year follow-up. Eur J Orthop Surg Traumatol. 2024 Jul;34(5):2429-2437. doi: 10.1007/s00590-024-03948-0. Epub 2024 Apr 17. |
| ID | Term |
|---|---|
| D010008 | Osteochondritis Dissecans |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D010007 | Osteochondritis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D054544 | Arthroplasty, Subchondral |
| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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