Assessing outcomes after ACL or PCL surgery using Mectascrew B
Cinical Outcomes of Mectascrew B Interference Screw
Medacta International SA · NCT06166784
This study is testing how well the Medacta Mectascrew B works for people recovering from ACL or PCL surgery one year after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medacta International SA (industry) |
| Locations | 1 site (Münich) |
| Trial ID | NCT06166784 on ClinicalTrials.gov |
What this trial studies
This observational prospective study aims to evaluate the clinical outcomes one year after surgery for patients undergoing reconstruction of anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) injuries using the Medacta Mectascrew B interference screw. Patients scheduled for surgery at OCM Klinik GmbH will be enrolled after providing informed consent. Data on demographics, preoperative conditions, surgical details, and postoperative outcomes will be collected to assess functional outcomes and knee stability. Radiological evaluations will also be performed to monitor any complications related to the surgical intervention.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with ACL or PCL tears requiring surgical reconstruction using the Mectascrew B.
Not a fit: Patients with contraindications to the Mectascrew B, malignancies, infections, or significant functional deficits in the affected limb may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of the Mectascrew B in improving recovery outcomes for ACL and PCL injuries.
How similar studies have performed: While this study focuses on a specific device, similar observational studies have shown promising outcomes in ACL and PCL reconstruction, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Münich
- OCM Klinik GmbH — Münich, Germany (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear