UnknownNot Applicable

Interference Screw Mectascrew-B Postmarket Study

Germany27 participantsStarted 2023-10-19

Plain-language summary

An observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.

Who can participate

Age range

18 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: * Both genders * Patients older than 18 years * ACL or PCL damage requiring primary ACL or PCL reconstruction * Patient requiring ACL or PCL surgery with the use of Medacta MectaScrew B interference screw, according to Manufacturer IFU's, i.e. reconstructive therapy of ruptures to the anterior or posterior cruciate ligament by means of autologous grafts * Patients who are willing to participate in the study and have signed informed consent form. Exclusion Criteria: * Patients with contraindications according to IFU's * Patients with malignant diseases (at the time of surgery) * Patients with proven or suspected infections (at the time of surgery) * Patients with functional deficits on the affected extremity (at the time of surgery) * Patients with known incompatibility or allergy to products materials (at the time of surgery) * Concomitant ligament injury (grade ≥ 3)

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

Functional outcomes evaluation

Timeframe: 12 months

Trial details

NCT IDNCT06166784

SponsorMedacta International SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-11

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear trials

Who can participate

Age range

18 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.