Post-Meniscectomy Pain Syndrome
Conditions
Keywords
meniscus, lateral, prosthesis
Brief summary
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.
Interventions
DEVICEImplantation of lateral meniscus prosthesis
Implantation of a lateral meniscus prosthesis after meniscectomy.
Sponsors
ATRO Medical B.V.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \< ± 3° of the mechanical axis 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
1. Has progressed knee osteoarthritis, Kellgren & Lawrence grade 3- 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 3. Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment 4. Has a varus or valgus knee deformity of \> 3° 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 16. Has an active infection or tumor (local or systemic) 17. Has any type of knee joint inflammatory disease including Sjogren's syndrome 18. Has neuropathic knee osteoarthropathy, also known as Charcot joint 19. Has any medical condition that does not allow possible arthroscopy of the knee 20. Has neurological deficit (sensory, motor, or reflex) 21. Anticipates having another lower extremity surgery during the study period 22. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura) 23. Has received any corticosteroid knee injections ≤ 3 months prior to surgery 24. Has proven osteoporosis 25. Is on immunostimulating or immunosuppressing agents 26. Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or study outcomes (e.g. have a leg length discrepancy \> 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 study period 28. Is an active smoker at the time of surgery 29. 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 | Description |
|---|---|---|
| Adverse events | 12 months after implantation. | Adverse events within 12 months after implantation. |
| Implant integrity | 12 months after implantation. | Assessed by MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OKS | 24 months. | OKS at 6, 12, 24 months. |
| EQ-5D-5L | 24 months. | EQ-5D-5L at 6, 12, 24 months. |
| WORQ | 24 months. | WORQ at 6 weeks, 3, 6, 12, 24 months. |
| SF-36 | 24 months. | SF-36 at 6, 12, 24 months. |
| Likert - Patient satisfaction | 24 months. | Patient satisfaction on a 5-point Likert scale at 6, 12, 24 months. |
| KOOS | 24 months. | KOOS (overall including all subscales) at 6 weeks, 3, 6, 12, 24 months. |
| IKDC Knee Examination Form | 24 months. | IKDC Knee Examination Form at screening, surgery, 6 weeks, 3, 6, 12, 24 months. |
| Knee X-ray (weight-bearing) | 24 months. | Knee X-ray (weight-bearing) at 6, 12, and 24 months to evaluate the height of the joint space. |
| Knee X-ray (weight-bearing, long-leg) | 24 months. | • Knee X-ray (weight-bearing, long-leg) at 6, 12, and 24 months to evaluate the mechanical axis. |
| Knee X-ray (non-weight-bearing, supine) | 24 months. | Knee X-ray (non-weight-bearing, supine) at 12, and 24 months to evaluate the mechanical axis. |
| Knee MRI (non-weight-bearing) | 24 months. | 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). |
| Tegner Activity Scale | 24 months. | Tegner Activity Scale at 6 weeks, 3, 6, 12, 24 months. |
| Lysholm | 24 months. | Lysholm scale at 6 weeks, 3, 6, 12, 24 months. |
Countries
Netherlands
Contacts
Primary ContactCDD
Outcome results
None listed