Analyzing the Mectascrew-C in ACL and PCL surgeries
Composite Interference Screw in the Surgical Reconstruction of Knee Cruciate Ligaments: a Prospective Observational Study
This study is testing how well a special screw used in knee surgeries for ACL and PCL injuries holds up after six months to see if it helps patients recover better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 16 Years to 60 Years |
| Sex | All |
| Sponsor | Medacta International SA Industry-sponsored |
| Locations | 1 site (Lugano) |
| Trial ID | NCT05791656 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the presence of the Mectascrew-C, a composite interference screw, at six months post-surgery for patients undergoing reconstruction of anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) injuries. Patients aged 16-60 scheduled for surgery will be enrolled after providing informed consent. Data will be collected from medical histories and follow-up visits at 1, 3, and 6 months to assess functional outcomes and knee stability. An MRI will be performed at six months to evaluate the reabsorption of the screw and correlate it with clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16-60 with confirmed ACL or PCL ruptures scheduled for surgical reconstruction.
Not a fit: Patients outside the age range of 16-60 or with degenerative bone conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and recovery for patients with ACL and PCL injuries.
How similar studies have performed: Similar studies have shown promise in evaluating surgical outcomes with composite screws, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes aged 16-60 yrs * Pre-operative MRI confirming the ACL or PCL rupture * Scheduled for surgical reconstruction of ACL or PCL * BMI\>18 and \<35 kg/m2 * Ability to give informed consent by signature Exclusion Criteria: * Age under 16 or over 60 yrs * Degenerative osteopathies * Local bone tumors * Deformities of the bone, or general conditions of the bone, which preclude the implantation in the opinion of a physician * Systemic diseases and metabolic disorders that may compromise the outcome of the surgery
Where this trial is running
Lugano
- EOC, Service of Orthopaedics and Traumatology — Lugano, Switzerland (Recruiting)
Study contacts
- Principal investigator: Christian Candrian, Prof Med — EOC , Service of Orthopaedics and Traumatology, Lugano (Switzerland)
- Study coordinator: Elisa Bonacina, PhD
- Email: bonacina@medacta.ch
- Phone: +41 91 696 60 60
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.