AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation

Study Overview
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Brief Summary
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The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.

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® medial 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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Feasibility of the Trammpolin® Medial Meniscus Prosthesis Intended to Restore the Medial Meniscus Function to Provide Pain Relief After Meniscectomy

Conditions
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Knee Injuries and Disorders

Intervention / Treatment
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* Device: Trammpolin medial meniscus prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has medial compartment knee pain and had a medial partial or total meniscectomy > 6 months ago. The lack of meniscus tissue is confirmed by patient history and MRI Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score) Is between age 18 and 70 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® medial meniscus prosthesis Is willing and able to comply to the clinical investigation required follow up visits, questionnaires, X-rays and MRI's Is able and willing to understand and sign the clinical investigation 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 potentially 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® medial meniscus prosthesis 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 > 30 at the time of screening Has a knee flexion contracture > 10° Has a knee flexion < 90° Had a previous High Tibial Osteotomy (HTO) < 1 year ago 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 clinical investigation period Has received any corticosteroid knee injections ≤ 3 months prior to surgery 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 clinical investigation period Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Early feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm<br>Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee. | Device: Trammpolin medial meniscus prosthesis<br>* Implantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the Trammpolin® medial meniscus prosthesis | Performance of the Trammpolin® medial meniscus prosthesis in improving pain as assessed by the Knee Osteoarthritis and injury Outcome Score (KOOS) Pain Sub-scale at 24 months post-operative compared to baseline (pre-operative) The minimum value is 0 and maximum value is 100, a score of 100 is being no pain and the highest attainable score | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Osteoarthritis and injury Outcome Score (KOOS) Pain | • Knee Osteoarthritis and injury Outcome Score (KOOS) Pain Sub-scale at 6 weeks, 3 months, 6 months, 12 and 24 months post-operative compared to baseline (pre-operative). A score of 100 is being no pain. | 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Knee Osteoarthritis and injury Outcome Score (KOOS) overall | at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). A score of 100 is being no pain . | at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). | 
| PAIN Visual Analog Scale (VAS) | at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 no pain and 10 worst pain | at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative | 
| Lysholm Knee Scoring Scale | scale at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). The Lysholm Knee Scoring Scale consists of eight items that asses: pain, instability, locking, swelling, limp, stair climbing, squatting, and need for support. Measurement level per item: mode of scoring (0-25); measurement level ordinal Measurement level total score: mode of scoring (0-100); measurement level ordinal 100 = no symptoms of impairment. Higher scores indicate a better outcome with fewer symptoms or disability. | at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Oxford Knee Score | at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). The Oxford Knee Score questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | at 6, 12 and 24 months | 
| Europol 5D health utility score | at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). Evaluates the generic quality of life, developed in Europe and widely used. Used for estimating QALY to make decisions in resource allocation. The EQ-5D questionnaire has two components: health state description and evaluation. Health state is measured in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In the evaluation part, the respondents evaluate their overall health status using the VAS. | at 6, 12 and 24 months | 
| Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ) | at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). The questionnaire consists of 13 items and has a total score from 0 ('very much trouble/ can't do') to 100 ('no trouble at all') | at 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Patient satisfaction on a 5-point Likert scale | at 6 months, 12 months and 24 months post-operative compared to baseline (pre-operative). The Likert scale consists of a series of statements about a topic, on which the respondent can indicate their level of agreement. For each item, a respondent is asked, using a series of ordered answer options, to indicate the extent to which he agrees with the statement, for example 'totally agree' or 'disagree'. The separate items together indicate the attitude of a respondent towards a subject. The questions uses a 5 or 7 point scale, from one extreme to the other. It is also called a satisfaction scale or satisfaction survey | at 6 months, 12 months and 24 months | 
| Knee X-ray (weight-bearing) | To evaluate the height of the joint space compared to baseline (pre-operative). | 12 months | 
| Knee MRI - Assessment of cartilage condition according to the modified Outerbridge Grading system at screening, 12 and 24 months - Assessment of relative position of the Trammpolin® medial meniscus prosthesis to the tibial plateau | Reference 24 CIP: (Jones) Assessment of relative position of the Trammpolin® medial meniscus prosthesis to the tibial plateau, i.e. extrusion will be performed according to the method as described by Jones: L. D. Jones, S. J. Mellon, N. Kruger, A. P. Monk, A. J. Price, and D. J. Beard, Medial meniscal extrusion: a validation study comparing different methods of assessment, Knee Surg Sports Traumatol Arthrosc, Apr. 2017, doi: 10.1007/s00167-017-4544-4. | At 12 and 24 months | 
| Biopsy of synovium and synovial fluid sample. In case the investigational device requires revision another biopsy is taken from the synovium and a second sample of the synovial fluid. | The baseline samples are stored in the freezer, to be used as baseline values in case the investigational device requires revision during the course of the study. During any secondary surgical procedure, another biopsy is taken from the synovium and a second sample of the synovial fluid. Samples will be compared in a qualitative/descriptive manner according to the method as described by Krenn in PATHOLOGY RESEARCH AND PRACTICE, 2002;198(5):317-25: hyperplasia/enlargement of synovial lining cell layer, inflammatory infiltration, activation of synovial stroma/pannus formation will be assessed. Synovial fluid samples at baseline will be compared to any later sample with respect to the presence and nature of foreign body particles. | At implantation and if applicable at explantation | 
| Safety of the Trammpolin® medial meniscus prosthesis | Incidence of adverse events (e.g. hospitalization) | 6 weeks, 3 months, 6 months, 12 months and 24 months | 
| Safety - Incidence of secondary surgery of the index knee | Incidence of secondary surgery of the index knee | 6 weeks, 3 months, 6 months, 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medial meniscus prosthesis, Symptomatic uni-compartmental pain