Actively Recruiting
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
Led by Istituto Ortopedico Rizzoli · Updated on 2025-07-01
59
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the long-term outcomes of revision anterior cruciate ligament (ACL) reconstruction using a specific surgical method called the single-bundle "Over-The-Top" technique combined with lateral extra-articular tenodesis, using an Achilles tendon allograft. This study focuses on patients who have undergone this type of surgery at least two years ago and aims to better understand the risks and benefits, especially concerning osteoarthritis development after revision ACL surgery. The surgical method being evaluated uses an Achilles tendon allograft, which is a graft taken from a donor rather than the patient's own tissue. This approach helps preserve the patient's ligamentous tissue and is thought to have favorable biomechanical properties. The study involves patients who have had this specific revision surgery, with or without additional procedures, and includes radiographic evaluation of the affected knee taken immediately before or after surgery. Participants will be assessed at least 24 months after their surgery through various clinical and radiographic tests. These include the Lysholm Knee Score, physical examinations, knee stability tests such as the anterior drawer, Lachman, and pivot shift tests, and imaging assessments like weight-bearing X-rays graded by the Kellgren-Lawrence scale. Other patient-reported and functional scores will also be collected to evaluate knee performance and pain. The study is observational and aims to follow participants long-term to monitor surgical outcomes and potential development of osteoarthritis.
CONDITIONS
Brief Title
Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years at the time of surgery
- Male and female gender
- Patients who have undergone revision anterior cruciate ligament reconstruction with single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft at least 2 years ago
- Radiograph taken immediately before or after surgery of the affected knee
- Provided consent to participate in the study
You will not qualify if you...
- Patients no longer accessible
- Patients who deny consent to participate
- Advanced knee osteoarthritis (Outerbridge grade III-IV) at surgery
- Severe obesity with BMI greater than 35
- Lower limb conditions preventing upright position with full weight-bearing during assessment
- Infection or hematological or rheumatic conditions at assessment
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.
Duration - At least 24 months after surgery
Participants who underwent revision anterior cruciate ligament reconstruction are observed and assessed for clinical and radiographic outcomes.
1 visit at least 24 months after surgery
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
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