Actively Recruiting
Led by Indonesia University · Updated on 2025-06-17
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are evaluating the functional outcomes of patients who have experienced a rupture of the anterior cruciate ligament (ACL) and undergone reconstruction surgery using hamstring grafts. The study compares two surgical techniques: the all-inside technique and the complete tibial tunnel technique. The hamstring graft, taken from the patient's posterior thigh, replaces the torn ligament during reconstruction to restore knee stability. Patients will be randomly assigned to receive ACL reconstruction surgery using either the all-inside technique, which creates shorter bone sockets secured with adjustable-loop suspensory fixation, or the complete tibial tunnel technique, which involves full-length bone tunnels and fixation with a bio-interference screw and fixed-loop suspensory device. Both methods use hamstring grafts, and surgeries will be performed under double-blind conditions. Participants will be followed up at 3, 6, 9, and 12 months after surgery at an outpatient orthopedic clinic. Evaluations will include measurements of tibial translation, pain severity using a visual analogue scale, International Knee Documentation Committee (IKDC) scores, and Tegner-Lysholm knee scoring scales. The diameter of the hamstring graft will also be recorded during surgery. These assessments aim to compare knee function and recovery between the two surgical techniques over one year.
CONDITIONS
Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo ACL reconstruction surgery using either the All-inside technique or the complete tibial tunnel technique.
1 surgery visit (in-person)
Duration - 12 months
Participants are assessed through anamnesis and physical examination to evaluate clinical outcomes such as tibial translation, pain severity, IKDC score, and Tegner score.
4 visits at 3, 6, 9, and 12 months postoperatively (in-person)
Total: 2 locations
1
Indonesian University Hospital
Depok, Indonesia
Actively Recruiting
2
Cipto Mangunkusumo Hospital
Jakarta Pusat, Indonesia
Actively Recruiting
P
Prof. Dr. dr. Andri M.T. Lubis SpOT (K)
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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