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Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction: Prospective Multicenter Randomized Clinical Trial With Hamstring Autograft
Led by Federal University of São Paulo · Updated on 2025-04-03
146
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two surgical methods for reconstructing the anterior cruciate ligament (ACL) using hamstring tendons in patients at increased risk of re-injury. It evaluates anatomical ACL reconstruction combined with extra-articular reconstruction of the anterolateral ligament (ALL) against isolated intra-articular ACL reconstruction using quintuple or sextuple hamstring autografts. The study focuses on reducing graft re-rupture and improving knee stability and function after surgery. Participants will be randomly assigned to one of two groups: one receiving ACL reconstruction combined with ALL reconstruction using a gracilis tendon graft, and the other receiving isolated anatomical ACL reconstruction with a larger diameter hamstring graft. The surgical procedures are carefully described, and both groups will be treated with the same number of implants. Patients will be monitored at 3, 6, 9, 12, and 24 months after surgery. During the study, patients will undergo clinical evaluations and complete questionnaires assessing knee function, pain, stability, anxiety, and fear of movement. Data collection will be performed both in person and remotely using secure mobile platforms. The primary outcomes are clinical failure rate and graft rupture rate at a minimum of two years. Secondary outcomes include various functional capacity and stability scores, as well as psychological assessments. Adherence is supported through scheduled messaging, and safety will be monitored throughout the follow-up period.
CONDITIONS
Brief Title
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 14 to 25 years if female, 16 to 25 years if male
- Presence of one or more risk factors: pivot-shift test greater than 2, chronic ACL injury over 12 months, athlete with Tegner Scale 7 or higher
- Tibial slope greater than 12 degrees
- Recurvatum between 5 and 15 degrees (asymmetric)
- Ligamentous hypermobility with Beighton Scale greater than 5
You will not qualify if you...
- Age over 40 years
- ACL revision surgery
- Grade 2 or 3 PCL injury
- Grade 2 or 3 MCL injury or grade 1 MCL injury with valgus aligned axis
- Grade 2 or 3 CPL injury according to Fanelli classification
- Recurrent patellar dislocation
- Severe chondral lesion larger than 1 cm2 (ICRS grade 3 or 4)
- Previous surgery on the same knee
- Kellgren Lawrence grade 3 or higher
- Autoimmune or rheumatologic inflammatory disease
- Injury to the opposite knee ligaments
- Malalignment greater than 5 degrees asymmetry between limbs or greater than 10 degrees varus or valgus axis deviation
- Graft diameter less than 7 mm
- Body mass index over 35 or under 18
- Active or treated malignant cancer
- Pregnancy or suspected pregnancy
- Psychiatric disorders
- Work leave due to disability or reduced income assistance when simulating worse health condition
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 - Surgery day plus initial recovery period
Participants undergo either combined intra- and extra-articular ACL reconstruction with anterolateral ligament reinforcement or isolated intra-articular ACL reconstruction with hamstring autograft.
1 surgical visit (in-person)
Duration - 24 months
Participants are evaluated postoperatively to monitor recovery, knee function, and complications at scheduled intervals.
Visits at 3, 6, 9, 12, and 24 months (in-person and remote assessments)
Trial Site Locations
Total: 2 locations
1
Sao Paulo Hospital
São Paulo, São Paulo, Brazil, 04024-002
Actively Recruiting
2
Parelheiros Hospital
São Paulo, São Paulo, Brazil, 04883-290
Actively Recruiting
Research Team
M
MARCOS VINICIUS CREDIDIO
C
CARLOS EDUARDO DA SILVEIRA FRANCIOZI, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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