NCT Number: NCT07023653
This study aims to compare the functional outcomes of patients with ACL rupture following ACL reconstruction surgery using hamstring grafts, between the all-inside technique and the complete tibial tunnel technique. The hamstring graft, which serves as the tissue substitute for the damaged ACL, is harvested from the posterior thigh of the patient and used to replace the torn ligament during reconstruction
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Indonesian University Hospital, Depok, Indonesia
This Study was conducted usingdouble blind randomized controlled trial (RCT), patients who agree to participate in the study will be randomized to undergo ACL reconstruction using either the All-inside technique or the complete tibial tunnel technique. Clinical outcomes, including tibial translation, pain severity, IKDC score, and Tegner score, will be evaluated through anamnesis and physical examination at the outpatient orthopedic clinic at 3, 6, 9, and 12 months postoperatively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All-inside ACL reconstruction technique avoids creating full-length bone tunnels. Instead, it uses retrograde drilling to form bone sockets, and the graft is secured with adjustable-loop suspensory fixation on both the femur and tibia.
Complete Tibial Tunnel Technique is a conventional technique for ACL reconstruction which involves the creation of full-length bone tunnels in the tibia for graft passage via an anterograde approach. Graft fixation is typically achieved using a bio-interference screw on the tibial side and a fixed-loop suspensory device on the femoral side
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Objective measurement of the anterior tibial translation relative to the femur will be performed using a rolimeter during the Lachman test.
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Pain scale on the injured knee, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Knee Function Assessment
Time frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
a tool to assess knee function
Time frame: Intra-operative
The thickness of the hamstring graft after harvesting and folding will be measured using a sizing block with various intra-operative hole sizes
Contact information is provided by the study sponsor or research team.
Indonesia University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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