Actively Recruiting
Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET): a Short-term Prospective Arthrometric Study
Led by Stefano Zaffagnini · Updated on 2026-04-22
51
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the outcomes of a specific surgical approach for repairing the anterior cruciate ligament (ACL), a key stabilizer in the knee that is often injured. This technique combines ACL reconstruction using the gracilis and semitendinosus tendons with a lateral extra-articular tenodesis (LET), which aims to improve knee stability. The study focuses on understanding knee stability shortly after surgery, particularly both anteroposterior and rotational laxity, to help guide rehabilitation and return to sport. The surgery under evaluation uses the "Over-the-top single-bundle technique" with the patient's own tendons combined with LET. This method has been used since 1998 and is the preferred procedure at the Rizzoli Orthopaedic Institute. The study follows patients who undergo this combined surgery to assess how stable their knees are during the first year after the operation. Participants will be monitored for 12 months after surgery with various tests to measure knee stability, such as accelerometer readings, arthrometer assessments, physical exams, and specific knee stability tests like the Anterior Drawer, Lachman, and Pivot Shift tests. Patient-reported outcome scores and pain levels will also be collected. The study seeks to provide valuable information for optimizing recovery and safely returning patients to their sports activities.
CONDITIONS
Brief Title
Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing isolated ACL reconstruction using gracilis and semitendinosus tendons with the over-the-top technique and LET.
- Both male and female patients.
- Patients who have given consent to participate in the study.
- Age between 18 and 50 years at the time of surgery.
You will not qualify if you...
- Previous surgery on the same limb (meniscectomy, prior ACL reconstruction, displaced fractures).
- Surgical technique different from Over-the-Top with LET using autologous gracilis and semitendinosus tendons.
- Other concomitant ligament injuries requiring surgical treatment.
- Patients undergoing additional procedures at the same time as ACL reconstruction and LET (e.g., concomitant osteotomy, meniscus transplant, cartilage procedure).
- Patients who did not provide informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo anterior cruciate ligament (ACL) reconstruction associated with lateral extra-articular tenodesis (LET) and receive immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - 12 months
Participants are followed up to assess clinical and biomechanical outcomes after surgery.
Multiple visits over 12 months for assessments including physical examination and knee function tests
Trial Site Locations
Total: 1 location
1
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
S
stefano zaffagnini
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here