Monitoring outcomes after ACL reconstruction surgery
Anterior Cruciate Ligament Reconstruction: Clinical Outcome at Middle and Long Term Follow-Up
Istituto Ortopedico Rizzoli · NCT03441659
This study is tracking how well people recover after ACL surgery over five years to see what helps them heal better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna, Italia) |
| Trial ID | NCT03441659 on ClinicalTrials.gov |
What this trial studies
This observational study includes patients undergoing surgical reconstruction of the anterior cruciate ligament (ACL) and aims to evaluate their clinical outcomes over time. Participants will be assessed preoperatively and at 6 months, 1 year, 2 years, and 5 years post-surgery through clinical visits or telephone interviews. The study will utilize questionnaires to gauge functional symptoms and will objectively measure knee stability using an innovative device with inertial sensors. By analyzing various clinical scores and patient data, the study seeks to identify factors influencing recovery and optimize future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 60 who are scheduled for ACL reconstruction surgery and can provide informed consent.
Not a fit: Patients who are unable to understand the study requirements or who do not provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of ACL reconstruction outcomes and improve rehabilitation protocols for patients.
How similar studies have performed: Previous studies on ACL reconstruction have shown varying outcomes, but this study's innovative approach to measuring knee stability is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have provided informed written written consent; 2. Patients aged between 18 and 60; 3. Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL) Exclusion Criteria: 1. Patients unable to understand and to want; 2. Patients who have not signed informed consent;
Where this trial is running
Bologna, Italia
- Stefano Zaffagnini — Bologna, Italia, Italy (RECRUITING)
Study contacts
- Study coordinator: Stefano Zaffagnini, MD
- Email: stefano.zaffagnini@ior.it
- Phone: 0516366567
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: ACL Injury