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AIR (Artificial Implant for Medial Meniscus Replacement) Study (AIR)

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ClinicalTrials.gov Identifier: NCT03696836
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
ATRO Medical B.V.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meniscectomy Osteo Arthritis Knee Device: Trammpolin® meniscus prosthesis Not Applicable

Detailed 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® 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  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Medial Knee Joint Pain With the Trammpolin® Meniscus Prosthesis
Estimated Study Start Date : October 11, 2018
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trammpolin® meniscus prosthesis
The patients will be implanted with the Trammpolin® meniscus prosthesis
Device: Trammpolin® meniscus prosthesis
Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement




Primary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score (KOOS) Pain sub-scale [ Time Frame: 24 Months ]
    Performance of the Trammpolin® meniscus prosthesis in improving pain

  2. Trammpolin® meniscus prosthesis device related complications [ Time Frame: 24 Months ]
    The nature and frequency of all adverse events observed during the study


Secondary Outcome Measures :
  1. KOOS Pain sub-scale [ Time Frame: 6 Weeks; 3, 6 and 12 Months ]
    KOOS Pain sub-scale

  2. Overall KOOS scale [ Time Frame: 6 Weeks; 3, 6, 12 and 24 Months ]
    Overall KOOS scale

  3. Lysholm scale [ Time Frame: 6 Weeks; 3, 6, 12 and 24 Months ]
    Lysholm scale

  4. IKDC objective scale [ Time Frame: 6 Weeks; 3, 6, 12 and 24 Months ]
    IKDC objective scale

  5. Knee X-ray [ Time Frame: 6 Weeks; 12 and 24 Months ]
    Joint space measurement

  6. Knee MRI [ Time Frame: 12 and 24 Months ]
    Cartilage damage and extrusion



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has medial compartment joint pain with > 6 months ago a medial partial meniscectomy as 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 30 and 65 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® meniscus prosthesis.
  6. Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI's
  7. Is able and willing to understand and sign the study 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 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® meniscus prosthesis (e.g., a focal lesion > 0.5 cm2 correlating to a circular defect of > 8 mm in diameter)
  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 > 32.5 at the time of screening
  12. Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis
  13. Has a knee flexion contracture > 10°
  14. Has flexion < 90°
  15. Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)
  16. Has insufficiency fractures or avascular necrosis of the medial compartment
  17. Has an active infection or tumor (local or systemic)
  18. Has any type of knee joint inflammatory disease including Sjogren's syndrome
  19. Has neuropathic knee osteoarthropathy, also known as Charcot joint
  20. Has any medical condition that does not allow possible arthroscopy of the knee
  21. Has neurological deficit (sensory, motor, or reflex)
  22. Is currently involved in another investigation of the lower extremity
  23. Anticipates having another lower extremity surgery during the study period
  24. Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura)
  25. Has received any corticosteroid knee injections ≤ 3 months prior to surgery
  26. Has chondrocalcinosis
  27. Has proven osteoporosis
  28. Is on immunostimulating or immunosuppressing agents
  29. 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)
  30. Is a female who is lactating, expecting, or is intending to become pregnant during the study period
  31. Is an active smoker
  32. Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's)
  33. Is a prisoner
  34. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696836


Locations
Netherlands
Maastricht UMC+
Maastricht, Netherlands, 6229 HX
Radboud UMC Not yet recruiting
Nijmegen, Netherlands, 6525 GA
Sint Maartenskliniek Not yet recruiting
Ubbergen, Netherlands, 6574 NA
Sponsors and Collaborators
ATRO Medical B.V.

Responsible Party: ATRO Medical B.V.
ClinicalTrials.gov Identifier: NCT03696836     History of Changes
Other Study ID Numbers: AM-001
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases