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The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the post-meniscectomy pain syndrome. The intended purpose of the system is to replace the lateral native meniscus and its function after meniscectomy by distributing tibio-femoral loads and provide a clinically relevant reduction of pain and improvement of joint function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral Meniscus Prosthesis | Experimental | Implantation of the Lateral Meniscus Prosthesis, intended to replace the function of the natural meniscus to provide unicompartmental pain relief in the meniscus-deficient knee. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of lateral meniscus prosthesis | Device | Implantation of a lateral meniscus prosthesis after meniscectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events within 12 months after implantation. | 12 months after implantation. |
| Implant integrity | Assessed by MRI. | 12 months after implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS | KOOS (overall including all subscales) at 6 weeks, 3, 6, 12, 24 months. | 24 months. |
| Lysholm | Lysholm scale at 6 weeks, 3, 6, 12, 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CDD | Contact | 0031616672227 | info@atromedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | Netherlands |
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The objective of the clinical investigation is to evaluate the safety and performance of the LMP system and to demonstrate that the system is able to replace the function of the natural meniscus to provide pain relief in the lateral compartment of the meniscus-deficient knee. No formal hypothesis testing will be conducted, given the feasibility design of this clinical investigation.
Evaluation of safety of the LMP system will occur throughout the investigation with the reporting of the nature and frequency of all adverse events observed during the clinical investigation and their timing, severity and relatedness to the investigational device or procedure. In addition, the incidence and nature of secondary surgical intervention will be assessed.
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| 24 months. |
| OKS | OKS at 6, 12, 24 months. | 24 months. |
| EQ-5D-5L | EQ-5D-5L at 6, 12, 24 months. | 24 months. |
| WORQ | WORQ at 6 weeks, 3, 6, 12, 24 months. | 24 months. |
| SF-36 | SF-36 at 6, 12, 24 months. | 24 months. |
| Likert - Patient satisfaction | Patient satisfaction on a 5-point Likert scale at 6, 12, 24 months. | 24 months. |
| Tegner Activity Scale | Tegner Activity Scale at 6 weeks, 3, 6, 12, 24 months. | 24 months. |
| IKDC Knee Examination Form | IKDC Knee Examination Form at screening, surgery, 6 weeks, 3, 6, 12, 24 months. | 24 months. |
| Knee X-ray (weight-bearing) | Knee X-ray (weight-bearing) at 6, 12, and 24 months to evaluate the height of the joint space. | 24 months. |
| Knee X-ray (weight-bearing, long-leg) | • Knee X-ray (weight-bearing, long-leg) at 6, 12, and 24 months to evaluate the mechanical axis. | 24 months. |
| Knee X-ray (non-weight-bearing, supine) | Knee X-ray (non-weight-bearing, supine) at 12, and 24 months to evaluate the mechanical axis. | 24 months. |
| Knee MRI (non-weight-bearing) | Knee MRI (non-weight-bearing) at implantation surgery (+(within 1 week, preferably peroperative), 6, 12, and 24 months for implant and joint integrity (cartilage status) assessment (including focal defects, bone marrow lesions, and bone tunnels/fixation sites). | 24 months. |