Early Artificial Lateral Prosthesis (NCT06705985) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Artificial Lateral Prosthesis
Netherlands16 participantsStarted 2024-11-21
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Is aged 18 to 70 years (inclusive) at the time of screening
✓. Has a history of partial or total meniscectomy
✓. 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
✓. Has a KOOS Pain of ≤ 75 at the time of screening
✓. 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)
✓. Has neutral alignment \< ± 3° of the mechanical axis
✓. Is willing to be implanted with the LMP System and to comply with instruction for use
✓. Is able and willing to do the study required follow-up visits, questionnaires, X-rays, and MRI
Exclusion criteria
✕. Has progressed knee osteoarthritis, Kellgren \& Lawrence grade 3- 4 in the lateral compartment
✕. 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
✕. Has medial compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the medial compartment
✕. Has a valgus alignment that is not passively correctable
✕. 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)
✕. Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment
✕. Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the patellar compartment