meniscus injury
Conditions
Interventions
The implantation of the meniscus prosthesis and fixation tape and anchoring
screws is conducted by means of an arthroscopic procedure, minimizing the
surgical damage to the joint. A regular arthrosc
Sponsors
ATRO Medical B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Has medial compartment knee pain and had a medial partial or total meniscectomy > 6 months ago. The lack of meniscus tissue is confirmed by patient history and MRI 2. Has a KOOS Pain of
Exclusion criteria
Exclusion criteria: 1. Has a symptomatic knee because of a tear that could potentially 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 Artimis* medial meniscus prosthesis 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 > 5° 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 30 at the time of screening 12. Has a knee flexion contracture > 10° 13. Has a knee flexion 2.5 cm [1 inch], causing a noticeable limp) 27. Is a female who is lactating, expecting, or is intending to become pregnant during the clinical investigation period 28. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer*s) 30. Has a condition or be in a situation that, in the Investigator*s opinion, may confound the clinical investigation results, may risk the safety of the patient, or may interfere significantly with the subject*s participation in the clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of the Artimis* medial 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 |
|---|---|
| Secondary endpoints: • KOOS Pain Sub-scale at 6 weeks, 3 months, 6 months and 12 months post-operative compared to baseline (pre-operative). • KOOS overall scale at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). • Visual Analog Scale (VAS) Pain 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). • Oxford Knee Score (OKS) at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). • EuroQol-5D-5L health utility score at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). • Work, Osteoarthritis and joint-Replacement Questionnaire (WORQ) at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). • Patient satisfaction on a 5-point Likert scale at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). • Knee X-ray at 12 months to evaluate the height of the joint space compared to baseline (pre-operative). • Knee MRI at 6 and 24 months after surgery to evaluate the cartilage damage compared to baseline (pre-operative) and amount of extrusion of the Artimis*medial meniscus prosthesis. • Biopsy of synovial fluid and synovium to evaluate foreign body reaction in the knee when the device is explanted (if applicable) compared to surgery. Safety endpoints: • The nature and frequency of all adverse events observed during the clinical investigation including their timing, severity and relatedness to the investigational device and/or procedure. • Incidence of secondary surgical intervention of the index knee. | — |
Countries
Netherlands
Outcome results
None listed