AIR (Artificial Implant for Medial Meniscus Replacement) Study

Study Overview
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Brief Summary
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The AIR Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® meniscus prosthesis system.

Detailed Description
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The Trammpolin® meniscus prosthesis is intended to replace the native medial meniscus to provide pain relief in the medial compartment of the knee joint, when this is caused by medial partial meniscectomy. Patients who meet the inclusion/exclusion criteria and who are implanted with the Trammpolin® meniscus prosthesis will be followed for 2 years. The patient reported outcome measures for knee pain and function, and knee clinical condition by MRI and X-ray is assessed post-operative compared to pre-operative.

Official Title
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Treatment of Medial Knee Joint Pain With the Trammpolin® Meniscus Prosthesis

Conditions
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Meniscectomy, Osteo Arthritis Knee

Intervention / Treatment
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* Device: Trammpolin® meniscus prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score) Is between age 30 and 65 years (inclusive) at the time of screening Has neutral alignment ± 5° of the mechanical axis, i.e., the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine to the center of the ankle joint, as confirmed by X-ray Is willing to be implanted with the Trammpolin® meniscus prosthesis. Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI's Is able and willing to understand and sign the study Informed Consent Form Is able to read and understand the national language of the country in which the relevant clinical site is located Exclusion Criteria: Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a Trammpolin® meniscus prosthesis (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter) Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment Has a varus or valgus knee deformity of > 5° requiring a tibial or femoral osteotomy Has a varus 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. 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 Had an ACL reconstruction performed < 9 months prior to surgery Has a BMI > 32.5 at the time of screening Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis Has a knee flexion contracture > 10° Has flexion < 90° Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO) Has insufficiency fractures or avascular necrosis of the medial compartment Has an active infection or tumor (local or systemic) Has any type of knee joint inflammatory disease including Sjogren's syndrome Has neuropathic knee osteoarthropathy, also known as Charcot joint Has any medical condition that does not allow possible arthroscopy of the knee Has neurological deficit (sensory, motor, or reflex) Is currently involved in another investigation of the lower extremity Anticipates having another lower extremity surgery during the study period Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura) Has received any corticosteroid knee injections ≤ 3 months prior to surgery Has chondrocalcinosis Has proven osteoporosis Is on immunostimulating or immunosuppressing agents Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing a noticeable limp) Is a female who is lactating, expecting, or is intending to become pregnant during the study period Is an active smoker Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's) Is a prisoner Has a condition or be in a situation that, in the Investigator's opinion, may confound the study results, or may interfere significantly with the subject's participation in the study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trammpolin® meniscus prosthesis<br>The patients will be implanted with the Trammpolin® meniscus prosthesis | Device: Trammpolin® meniscus prosthesis<br>* Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale | Performance of the Trammpolin® meniscus prosthesis in improving pain | 24 Months | 
| Trammpolin® meniscus prosthesis device related complications | The nature and frequency of all adverse events observed during the study | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Pain sub-scale | KOOS Pain sub-scale | 6 Weeks; 3, 6 and 12 Months | 
| Overall KOOS scale | Overall KOOS scale | 6 Weeks; 3, 6, 12 and 24 Months | 
| Lysholm scale | Lysholm scale | 6 Weeks; 3, 6, 12 and 24 Months | 
| IKDC objective scale | IKDC objective scale | 6 Weeks; 3, 6, 12 and 24 Months | 
| Knee X-ray | Joint space measurement | 6 Weeks; 12 and 24 Months | 
| Knee MRI | Cartilage damage and extrusion | 12 and 24 Months |