Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Rupture

• Registration Number: NCT07023653
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2024-10-15
• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tibial Translation	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.
Pain scale using Visual Analogue Scales	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.
International Knee Documentation Comittee (IKDC) Score	Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery	Knee Function Assessment
Tegner-Lysholm Score Knee Scoring Scale	Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery	a tool to assess knee function
Hamstring Graft Diameter	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

Trial Locations

Locations (2)

Indonesian University Hospital; 🇮🇩 Depok, Indonesia

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, Indonesia