AIR (Artificial Implant for Medial Meniscus Replacement) Study

NCT03696836 | Terminated DMC

• 1 other identifier: AM-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Meniscectomy; Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• KOOS Pain sub-scale

  6 Weeks; 3, 6 and 12 Months

• Overall KOOS scale

  6 Weeks; 3, 6, 12 and 24 Months

• Lysholm scale

  6 Weeks; 3, 6, 12 and 24 Months

• IKDC objective scale

  6 Weeks; 3, 6, 12 and 24 Months

• Knee X-ray

  6 Weeks; 12 and 24 Months

Study Arms (1)

Trammpolin® meniscus prosthesis

EXPERIMENTAL

The patients will be implanted with the Trammpolin® meniscus prosthesis

Device: Trammpolin® meniscus prosthesis

Interventions

Trammpolin® meniscus prosthesis DEVICE

Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement

Trammpolin® meniscus prosthesis

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has medial compartment joint pain with \> 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
• Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
• Is between age 30 and 65 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® meniscus prosthesis.
• Is able to do the study required follow up visits, questionnaires, X-rays, CT-scans, and MRI's
• Is able and willing to understand and sign the study Informed Consent Form
• Is able to read and understand the national language of the country in which the relevant clinical site is located

You may not qualify if:

• Has a symptomatic knee because of a tear that could 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® meniscus prosthesis (e.g., a focal lesion \> 0.5 cm2 correlating to a circular defect of \> 8 mm in diameter)
• 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 \> 32.5 at the time of screening
• Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the Trammpolin® meniscus prosthesis
• Has a knee flexion contracture \> 10°
• Has flexion \< 90°
• Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO)

Sponsors & Collaborators

• ATRO Medical B.V.: lead

Study Sites (3)

Maastricht UMC+

Maastricht, 6229 HX, Netherlands

Location

Radboud UMC

Nijmegen, 6525 GA, Netherlands

Location

Sint Maartenskliniek

Ubbergen, 6574 NA, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: October 11, 2018
• Primary Completion: January 7, 2021
• Study Completion: July 1, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)