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

ATRO Medical B.V.10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Injuries and Disorders

Interventions

Trammpolin medial meniscus prosthesisDEVICE

Implantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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 2. Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score) 3. Is between age 18 and 70 years (inclusive) at the time of screening 4. 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 5. Is willing to be implanted with the Trammpolin® medial meniscus prosthesis 6. Is willing and able to comply to the clinical investigation required follow up visits, questionnaires, X-rays and MRI's 7. Is able and willing to understand and sign the clinical investigation Informed Consent Form 8. Is able to read and understand the national language of the country in which the relevant clinical site is located Exclusion Criteria: 1. Has a symptomatic knee because of a tear that could potentially be addressed by a repeat partial meniscectomy 2. 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 3. Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilage score in the lateral compartment 4. Has a varus or valgus knee deformity of \> 5° requiring a tibial or femoral osteotomy 5. Has a varus 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. 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 10. Had an ACL reconstruction performed \< 9 months prior to surgery 11. Has a BMI \> 30 at the time of screening 12. Has a knee flexion contracture \> 10° 13. Has a knee flexion \< 90° 14. Had a previous High Tibial Osteotomy (HTO) \< 1 year ago 15. Has insufficiency fractures or avascular necrosis of the medial 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. Is currently involved in another investigation of the lower extremity 22. Anticipates having another lower extremity surgery during the clinical investigation period 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 KOOS (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 clinical investigation period 28. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's) 29. 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

Locations (3)

MUMC+

Maastricht, Netherlands

RECRUITING

Sint Maartenskliniek

Nijmegen, Netherlands

RECRUITING

Haaglanden Medisch Centrum

The Hague, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 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 .

Time frame: 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"

Time frame: 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.

Central Contacts

J. Lugies

CONTACT

+31650401596 jose.lugies@atromedical.com

A. Brinks

CONTACT

+31633665030 anita.brinks@atromedical.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.