NCT03696836

AIR (Artificial Implant for Medial Meniscus Replacement) Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: ATRO Medical B.V. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Meniscectomy
• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Trammpolin® meniscus prosthesis	Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement

Timeline

• Start date: 2018-10-11
• Primary completion: 2021-01-07
• Completion: 2021-07-01
• First posted: 2018-10-05
• Last updated: 2021-08-30

Locations

3 sites across 1 country: Netherlands