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Halted prematurely
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The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system.
The Trammpolin® meniscus prosthesis is intended to replace the native medial meniscus to provide pain relief in the medial compartment of the knee joint, when this is caused by medial partial meniscectomy.
Patients who meet the inclusion/exclusion criteria and who are implanted with the Trammpolin® meniscus prosthesis will be followed for 2 years. The patient reported outcome measures for knee pain and function, and knee clinical condition by MRI and X-ray is assessed post-operative compared to pre-operative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trammpolin® meniscus prosthesis | Experimental | The patients will be implanted with the Trammpolin® meniscus prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trammpolin® meniscus prosthesis | Device | Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale | Performance of the Trammpolin® meniscus prosthesis in improving pain | 24 Months |
| Trammpolin® meniscus prosthesis device related complications | The nature and frequency of all adverse events observed during the study | 24 Months |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS Pain sub-scale | KOOS Pain sub-scale | 6 Weeks; 3, 6 and 12 Months |
| Overall KOOS scale | Overall KOOS scale | 6 Weeks; 3, 6, 12 and 24 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht UMC+ | Maastricht | 6229 HX | Netherlands | |||
| Radboud UMC |
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| Lysholm scale | Lysholm scale | 6 Weeks; 3, 6, 12 and 24 Months |
| IKDC objective scale | IKDC objective scale | 6 Weeks; 3, 6, 12 and 24 Months |
| Knee X-ray | Joint space measurement | 6 Weeks; 12 and 24 Months |
| Knee MRI | Cartilage damage and extrusion | 12 and 24 Months |
| Nijmegen |
| 6525 GA |
| Netherlands |
| Sint Maartenskliniek | Ubbergen | 6574 NA | Netherlands |