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

ConditionAnterior Cruciate Ligament Rupture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIndonesia University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with anterior cruciate ligament rupture

Patients within the age range of 18 to 65 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • All-Inside Techniques

    Procedure/Surgery

    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 techniques

    Procedure/Surgery

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: All-Inside TechniqueActive comparator 1 intervention
Group B: Complete Tibial TunnelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tibial Translation

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
2

Pain scale using Visual Analogue Scales

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
3

International Knee Documentation Comittee (IKDC) Score

Knee Function Assessment

Time frame
Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery
4

Tegner-Lysholm Score Knee Scoring Scale

a tool to assess knee function

Time frame
Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov
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