Long-term results of ACL revision surgery using Achilles tendon allograft
Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using Over The Top Single-bundle Technique and Lateral Extra-articular Tenodesis With Achilles Tendon Allograft.
This study tests how well revision ACL surgery using an Achilles tendon graft works for patients two years after their surgery and what factors might affect their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06868147 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term clinical and radiographic outcomes of patients who have undergone revision anterior cruciate ligament (ACL) reconstruction using a single-bundle technique combined with external tenodesis utilizing an Achilles tendon allograft. It focuses on understanding how various factors, such as the type of graft used and the extent of knee damage, influence surgical outcomes. The study aims to gather data from patients who are at least two years post-surgery to assess the effectiveness of this surgical approach.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 to 50 who have undergone revision ACL reconstruction with a specific surgical technique and are at least two years post-surgery.
Not a fit: Patients with advanced knee osteoarthritis, severe obesity, or other significant lower limb conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into optimizing ACL revision surgeries, potentially leading to improved patient outcomes.
How similar studies have performed: While there have been various studies on ACL reconstruction techniques, this specific approach using Achilles tendon allograft in a revision context is less commonly explored, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 and 50 years at the time of surgery; 2. Male and female gender; 3. Patients who have undergone revision of anterior cruciate ligament reconstruction with a single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft, with or without associated procedures, at least 2 years post-surgery; 4. A radiograph taken immediately before or after the surgery of the affected knee; 5. Patients who have provided consent to participate in the study. Exclusion Criteria: 1. Patients no longer accessible; 2. Patients who deny consent to participate in the study; 3. Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery; 4. Severe obesity (BMI \> 35); 5. Lower limb conditions that prevent the patient from maintaining an upright position with full weight-bearing during the assessment; 6. Infection or hematological or rheumatic conditions at the time of the assessment.
Where this trial is running
Bologna
- IRCCS Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: stefano zaffagnini
- Email: stefano.zaffagnini@unibo.it
- Phone: 0516366075
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.