Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Indonesia University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Tibial Translation
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
All-Inside Technique
Patients With ACL Ruptures will undergo ACL reconstruction surgery with All-inside techniques
Intervention: All-Inside Techniques (Procedure)
Complete Tibial Tunnel
Patients With ACL Ruptures will undergo ACL reconstruction surgery with complete tibial tunnel techniques
Intervention: Complete Tibial Tunnel techniques (Procedure)
Outcomes
Primary Outcomes
Tibial Translation
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.
Pain scale using Visual Analogue Scales
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.
International Knee Documentation Comittee (IKDC) Score
Time Frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
Knee Function Assessment
Tegner-Lysholm Score Knee Scoring Scale
Time Frame: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
a tool to assess knee function
Hamstring Graft Diameter
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Andri Maruli Tua Lubis
Prof. Dr. Andri M.T. Lubis, MD
Indonesia University