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

Last updated: March 16, 2022
Sponsor: ATRO Medical B.V.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Injuries

Treatment

N/A

Clinical Study ID

NCT05297175
AM-002
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Has medial compartment knee pain and had a medial partial or total meniscectomy > 6months 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 linedrawn from the center of the femoral head to the medial tibial spine and a line drawnfrom 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 ConsentForm
  8. Is able to read and understand the national language of the country in which therelevant clinical site is located

Exclusion

Exclusion Criteria:

  1. Has a symptomatic knee because of a tear that could potentially be addressed by arepeat partial meniscectomy
  2. Has evidence of a modified Outerbridge Grade IV cartilage loss on the medial tibialplateau or femoral condyle that potentially could contact a Trammpolin® medialmeniscus prosthesis
  3. Has lateral compartment pain and Grade III or Grade IV modified Outerbridge cartilagescore 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 ofthe anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/orlateral collateral ligament (LCL) and/or medial collateral ligament (MCL)
  7. Has significant trochlear dysplasia, patellar instability or symptomatic patellarmisalignment
  8. Has patellar compartment pain and Grade III or Grade IV modified Outerbridge cartilagescore in the patellar compartment.
  9. Compared to a normal knee, has obvious radiological evidence of medial femoralsquaring, anatomical variance in the medial tibial plateau, or irregularly shapedcartilage 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 investigationperiod
  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 affectambulation or KOOS (e.g. have a leg length discrepancy > 2.5 cm [1 inch], causing anoticeable limp)
  27. Is a female who is lactating, expecting, or is intending to become pregnant during theclinical investigation period
  28. Is mentally incapacitated (incapable of appraising or controlling conduct) or havemental disability (e.g., dementia or Alzheimer's)
  29. Has a condition or be in a situation that, in the Investigator's opinion, may confoundthe clinical investigation results, may risk the safety of the patient, or mayinterfere significantly with the subject's participation in the clinical investigation

Study Design

Total Participants: 10
Study Start date:
October 19, 2021
Estimated Completion Date:
December 31, 2024

Study Description

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.

Connect with a study center

  • Haaglanden Medisch Centrum

    Den Haag, 2597 AX
    Netherlands

    Active - Recruiting

  • MUMC+

    Maastricht, 6229 HX
    Netherlands

    Active - Recruiting

  • Sint Maartenskliniek

    Nijmegen, 6574 NA
    Netherlands

    Active - Recruiting

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