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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteo Arthritis Knee; Meniscectomy
• Intervention / Treatment: Device: Trammpolin® meniscus prosthesis

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
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht UMC+
  • Nijmegen, Netherlands, 6525 GA
    • Radboud umc
  • Ubbergen, Netherlands, 6574 NA
    • Sint Maartenskliniek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ATRO Medical B.V.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: AM-001 (TheraBionic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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