NCT05297175

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

Feasibility of the Trammpolin® Medial Meniscus Prosthesis Intended to Restore the Medial Meniscus Function to Provide Pain Relief After Meniscectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ATRO Medical B.V. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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® 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.

Conditions

• Knee Injuries and Disorders

Interventions

Type	Name	Description
DEVICE	Trammpolin medial meniscus prosthesis	Implantation of the Trammpolin medial meniscus prosthesis in patients with a severe medial meniscus damage

Timeline

• Start date: 2021-10-19
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

3 sites across 1 country: Netherlands