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 range
18 Years – 70 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 varus or valgus knee deformity of \> 3°
. 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