Clinical trial NCT07023653: Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
Official title: Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: All-inside Techniques
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with anterior cruciate ligament rupture
* Patients within the age range of 18 to 65 years

Exclusion Criteria:

* Patients with Multiple Ligament Injuries in the Knee Joint
* Patients with a pregnancy condition
* Patients with Severe Osteochondral Defect (ICRS 4)
* Patients with signs of inflamation in knee joint

Primary outcomes:
measure: Tibial Translation
timeFrame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
measure: Pain scale using Visual Analogue Scales
timeFrame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
measure: International Knee Documentation Comittee (IKDC) Score
timeFrame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
measure: Tegner-Lysholm Score Knee Scoring Scale
timeFrame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
measure: Hamstring Graft Diameter
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Depok
country: Indonesia
facility: Indonesian University Hospital
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
Study officials:
affiliation: Indonesia University
name: Prof. Dr. dr. Andri M.T. Lubis SpOT (K)
role: PRINCIPAL_INVESTIGATOR
References:
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