meniscus injury Osteoarthritis
Conditions
Interventions
A regular arthroscopic inspection is performed through two or three portals in
the skin and capsule on the anterior side of the knee. The lateral portal is
used for the arthroscopic camera and the m
Sponsors
ATRO Medical B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. 1. Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI 2. Has a KOOS Pain of * 75 (100 being the highest attainable and 0 is no pain) 3. Is between age 30 and 65 years (inclusive) at the time of screening 4. Has neutral alignment ± 5º of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint, as confirmed by X-ray 5. Is willing to be implanted with the Trammpolin® meniscus prosthesis. 6. Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI*s 7. Is able and willing to understand and sign the study Informed Consent Form 8. Is able to read and understand the national language of the country in which the relevant clinical site is located
Exclusion criteria
Exclusion criteria: 1. Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy 2. Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm correlating to a circular defect of > 8 mm in diameter) 3. Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment 4. Has a varus or valgus knee deformity of > 5º requiring a tibial or femoral osteotomy 5. Has a varus alignment that is not passively correctable 6. Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL) 7. Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment 8. Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment. 9. Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface 10. Had an ACL reconstruction performed 32.5 at the time of screening 12. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis 13. Has a knee flexion contracture > 10º 14. Has flexion 2.5 cm [1 inch], causing a noticeable limp) 30. Is a female who is lactating, expecting, or is intending to become pregnant during the study period 31. Is an active smoker 32. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer*s) 33. Is a prisoner 34. Has a condition or be in a situation that, in the Investigator*s opinion, may confound the study results, or may interfere significantly with the subject*s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of the Trammpolin® meniscus prosthesis in improving pain as assessed by the KOOS Pain Sub-scale at 24 months post-operative compared to baseline (pre-operative). | — |
Secondary
| Measure | Time frame |
|---|---|
| The following exploratory endpoints will be analyzed from the participant data collected from this study: * KOOS Pain Sub-scale at 6 weeks, 3 months, 6 months and 12 months post-operative compared to baseline (pre-operative). * Overall KOOS scale at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). * Lysholm scale at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). * IKDC objective scale at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). * X-ray at 6 weeks, 12 and 24 months to evaluate the height of the joint space compared to baseline (pre-operative). * MRI scan at 12 and 24 months after surgery to evaluate the amount of extrusion of the Trammpolin® meniscus prosthesis. | — |
Countries
Netherlands
Outcome results
None listed