UnknownNot Applicable

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

Netherlands10 participantsStarted 2021-10-19

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. Has a symptomatic knee because of a tear that could potentially be addressed by a repeat partial meniscectomy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Performance of the Trammpolin® medial meniscus prosthesis

Timeframe: 24 months

Trial details

NCT IDNCT05297175

SponsorATRO Medical B.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09

Contact for this trial

J. Lugies

+31650401596 jose.lugies@atromedical.com

View on ClinicalTrials.gov More Knee Injuries and Disorders trials