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

NCT05297175 | Unknown DMC

• 1 other identifier: AM-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Knee Injuries and Disorders

Keywords

Medial meniscus prosthesis; Symptomatic uni-compartmental pain

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Secondary Outcomes (13)

• Knee Osteoarthritis and injury Outcome Score (KOOS) Pain

  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).

• PAIN Visual Analog Scale (VAS)

  at 6 weeks, 3 months, 6 months, 12 months and 24 months post-operative

• Lysholm Knee Scoring Scale

  at 6 weeks, 3 months, 6 months, 12 months and 24 months

• Oxford Knee Score

  at 6, 12 and 24 months

Study Arms (1)

Single arm

OTHER

Implantation of a medial meniscus prosthesis in the medial knee compartment of a post medial meniscectomy knee.

Device: Trammpolin medial meniscus prosthesis

Interventions

Trammpolin medial meniscus prosthesis DEVICE

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

Single arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Has a KOOS Pain of ≤ 75 (100 being no pain and the highest attainable score)
• Is between age 18 and 70 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® medial meniscus prosthesis
• Is willing and able to comply to the clinical investigation required follow up visits, questionnaires, X-rays and MRI's
• Is able and willing to understand and sign the clinical investigation 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 potentially 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® medial meniscus prosthesis
• 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 \> 30 at the time of screening
• Has a knee flexion contracture \> 10°
• Has a knee flexion \< 90°
• Had a previous High Tibial Osteotomy (HTO) \< 1 year ago
• Has insufficiency fractures or avascular necrosis of the medial compartment

Sponsors & Collaborators

• ATRO Medical B.V.: lead
• Avania: collaborator

Study Sites (3)

MUMC+

Maastricht, 6229 HX, Netherlands

RECRUITING

Sint Maartenskliniek

Nijmegen, 6574 NA, Netherlands

RECRUITING

Haaglanden Medisch Centrum

The Hague, 2597 AX, Netherlands

RECRUITING

MeSH Terms

Conditions

Knee Injuries; Disease

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• T. van Tienen, MD. PhD.

  Sponsor GmbH

  STUDY DIRECTOR

Central Study Contacts

J. Lugies

CONTACT

+31650401596; jose.lugies@atromedical.com

A. Brinks

CONTACT

+31633665030; anita.brinks@atromedical.com

Study Design

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

Model Details: Early feasibility study

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 28, 2022
• Study Start: October 19, 2021
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)