post meniscectomy pain pain after meniscectomy
Conditions
Interventions
Implantation with the lateral meniscus prosthesis (LMP) system.
Sponsors
ATRO Medical B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Is aged 18 to 70 years (inclusive) at the time of screening 2. Has a history of partial or total meniscectomy 3. Has post-meniscectomy pain syndrome (defined as symptomatic unicompartmental pain in the meniscus- deficient knee without severe cartilage damage- Kellgren & Lawrence grade 3-4) in the lateral compartment as confirmed by patient history and MRI 4. Has a KOOS Pain of <= 75 at the time of screening 5. Failed conservative treatment options (non-operative treatments of the knee, i.e., self-management exercise programs, physical therapy, braces, pain medication, and intra-articular corticosteroids) 6. Has neutral alignment of the mechanical axis: valgus less than 5° 7. Is willing to be implanted with the LMP System and to comply with instruction for use 8. Is able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRI 9. Is able and willing to understand and sign the study Informed Consent Form 10. Is able to read and understand the national language of the country in which the clinical site is located.
Exclusion criteria
Exclusion criteria: 1. Has severe knee osteoarthritis; Kellgren & Lawrence grade 4 in the lateral compartment 2. Has evidence of a modified Outerbridge Grade IV cartilage loss on the lateral tibial plateau or femoral condyle that potentially could contact the meniscus prosthesis > 2cm2 3. Has medial compartment pain Grade IV modified Outerbridge cartilage score > 2cm2 4. Has valgus knee alignment > 5° 5. Has a valgus 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. Had an ACL reconstruction performed < 9 months prior to surgery 10. Has a BMI > 35 at the time of screening 11. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the lateral meniscus prosthesis 12. Has a knee flexion contracture > 10° 13. Has flexion < 90° 14. Had a knee alignment correction osteotomy < 9 months ago 15. Has insufficiency fractures or avascular necrosis of the lateral compartment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Safety assessed by device related (S)AEs within 12 months of surgery. • Knee MRI (non-weight-bearing) at 12 months (extrusion measurement as measure for prosthesis integrity). | — |
Secondary
| Measure | Time frame |
|---|---|
| • The nature and frequency of all adverse events observed during the study including their timing, severity, and relatedness to the investigational device. • Incidence of secondary surgical intervention of the index knee. • Knee MRI (non-weight-bearing) at 12 months or explantation (extrusion measurement as measure for prosthesis and joint integrity including cartilage status). | — |
Countries
Netherlands
Contacts
Public ContactT Struik
ATRO Medical B.V.
Outcome results
None listed