Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
Recruiting now · Not applicable
Conditions studied: Anterior Cruciate Ligament Rupture, Ligament Knee Injury
In brief
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
Key facts
- Study ID
- NCT06505525
- Run by
- Federal University of São Paulo
- People needed
- 146
- Starts
- 2022-08-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-04-03
Who can join
Age: 14 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients from the hospital's demand (emergency care and outpatient care) and from CROSS (Center for Regulation of Health Service Offers) who present one or more risk factors will be included:
- Age (Female 14 years - 25 years and Male 16 years - 25 years);
- Pivot-shift test > 2;
- Chronic ACL injury (>12 months);
- Athlete (Tegner Scale ≥ 7);
- Tibial slope > 12 degrees;
- Recurvatum > 5 degrees and < 15 degrees (asymmetric);
- Ligamentous Hypermobility (Beighton Scale > 5).
- Non-Inclusion Criteria
- Individuals over 40 years of age will not be included;
- ACL revision;
- PCL injury (grade 2 and 3);
- MCL injury (grade 2 and 3) or (grade 1 with valgus aligned axis);
- CPL injury (grade 2 and 3 according to Fanelli classification);
- Recurrent patellar dislocation;
- Severe chondral lesion (ICRS grade 3 and 4) larger than 1cm2;
- Previous ipsilateral knee surgery;
- Kellgren Lawrence grade 3 or more;
- Autoimmune/rheumatologic inflammatory disease;
- Contralateral knee ligament injury;
- Malalignment > 5 degrees clinical asymmetry between limbs or symmetric > 10 degrees axis deviation to varus (corresponding to > 4 degrees varus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination) or > 10 degrees axis deviation to valgus (corresponding to > 16 degrees valgus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination);
- Graft diameter < 7 mm;
- BMI > 35 or < 18;
- Active or undergoing treatment for malignant neoplasia;
- Pregnancy or suspected pregnancy;
You may not qualify if…
- Leave of absence from work due to disability or reduced income assistance (worker's compensation) whenever one of the investigators considers that the participant may be simulating a worse health condition than reality in order to receive financial assistance with work leave.
Where it is running
- Sao Paulo Hospital — São Paulo, São Paulo, Brazil (enrolling)
- Parelheiros Hospital — São Paulo, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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