Actively Recruiting
Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
Led by Federal University of São Paulo · Updated on 2025-04-03
146
Participants Needed
2
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Abstract Introduction: Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide. There are several ways to prepare the graft using these tendons. One can prioritize increasing the diameter of an isolated intra-articular graft or alternatively, using one graft limb as an extra-articular reinforcement via the anterolateral ligament (ALL) reconstruction, with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts. Objective: To compare, through a prospective and randomized clinical trial, intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft. Methods: 146 patients will be randomized into two groups of 73 patients. Patients included in the study will be evaluated preoperatively and after surgery at 3, 6, 9, 12, and 24 months postoperatively. The primary outcomes will be clinical failure rate and graft rerupture rate. Secondary outcomes will include functional capacity assessed through IKDC, Lysholm KOOS, and Tegner scores, pain using the VAS, as well as stability assessed by digital rolimeter and objective IKDC. Kinesiophobia and anxiety will be measured using the Tampa scale and Anxiety and Depression scale. Keywords: Rupture, Anterior Cruciate Ligament, Anterior Cruciate Ligament Reconstruction
CONDITIONS
Official 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, or 16 to 25 years if male
- Presence of one or more risk factors such as:
- Pivot-shift test greater than 2
- Chronic ACL injury over 12 months
- Athlete with Tegner Scale score of 7 or higher
- Tibial slope greater than 12 degrees
- Recurvatum between 5 and 15 degrees (asymmetric)
- Ligamentous hypermobility with Beighton Scale over 5
- Patients from hospital emergency or outpatient care and from the Center for Regulation of Health Service Offers (CROSS)
You will not qualify if you...
- Age over 40 years
- Revision of ACL surgery
- Posterior cruciate ligament (PCL) injury grade 2 or 3
- Medial collateral ligament (MCL) injury grade 2 or 3, or grade 1 with valgus aligned axis
- Posterolateral corner (CPL) injury grade 2 or 3
- Recurrent patellar dislocation
- Severe cartilage damage larger than 1 cm2 (ICRS grade 3 or 4)
- Previous surgery on the same knee
- Kellgren Lawrence grade 3 or higher osteoarthritis
- Autoimmune or rheumatologic inflammatory disease
- Injury to the opposite knee ligaments
- Limb malalignment greater than 5 degrees asymmetry or greater than 10 degrees valgus or varus deviation
- Graft diameter less than 7 mm
- Body mass index (BMI) less than 18 or greater than 35
- Active cancer or undergoing treatment for malignant neoplasia
- Pregnancy or suspected pregnancy
- Psychiatric disorders
- Work leave or disability compensation suspected of simulating worse health condition
AI-Screening
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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
CONTACT
C
CARLOS EDUARDO DA SILVEIRA FRANCIOZI, PhD
CONTACT
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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