Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique

Study Overview
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Brief Summary
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This study intends to perform an all-inside and complete tibial tunnel ACL reconstruction technique in 60 patients, and compare the clinical and radiological outcomes of the two surgical procedures through follow-up.

Detailed Description
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This is a prospective randomized, controlled, single-center clinical trial study on ACL reconstruction surgery technique. In this study, 60 patients with ACL rupture were recruited according to the enrollment criteria. The recruited patients were randomly divided into groups. The ratio of the control group is 1:1. In this study, 30 patients with ACL rupture in the experimental group will be treated with all-inside reconstruction technique, and 30 patients with ACL rupture in the control group will be treated with complete tibial tunnel technique. All operations will be performed with 4-strand autologous semitendinosus tendon. All fixations will be performed using an adjustable cortical suspensory system. After reconstruction, all subjects will participate in the collection of clinical function scores including Marx Activity score, IKDC score, and clinical evaluation including physical examination, joint laxity, CT and MRI imaging analysis.

Official Title
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Comparison of Two ACL Reconstruction Techniques: All-inside Versus Complete Tibial Tunnel Technique Using Adjustable Suspensory Fixation

Conditions
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Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Procedure: Anterior Cruciate Ligament Reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have provided informed written written consent; Patients aged between 18 and 45; Patients undergoing reconstructive surgical treatment of the anterior cruciate ligament (ACL) Patients undergoing ACL reconstruction with a 8 mm four-strand semitendinosus autograft Exclusion Criteria: Patients who have not signed informed consent; Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery Revision procedures Patients unable to lay still in an MRI or CT scanner Patients with a torn ACL or previous ACL reconstruction in the contralateral knee. Patients who had an excessive tibial slope >12 degrees

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All-inside technique<br>Both of the femoral and tibial tunnel will be drilled in a retrograde manner using flip-cutter and femoral and tibial sockets will be created. Graft will be passed from the portal. Adjustable suspensory cortical fixation both on tibial and femoral side will be used. | Procedure: Anterior Cruciate Ligament Reconstruction<br>* Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft<br>|
| Active Comparator: Complete tibial tunnel technique<br>Femoral tunnel will be drilled in an inside-outside manner using standard technique. Then the tibial tunnel will be drilled completely. Graft will be passed from the tibial tunnel. Adjustable suspensory cortical fixation both on the tibial and femoral side will be used. | Procedure: Anterior Cruciate Ligament Reconstruction<br>* Anterior Cruciate Ligament Reconstruction with four strand semitendinosus graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal to Noise Quotient | Graft maturation on MRI using T2 Turbo Spin Echo (TSE) sequence without fat saturation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Computed Tomography (CT) imaging of Tunnels | Femoral and Tibial Tunnel Morphological Changes | 1 day, 6 months, 1 year | 
| International Knee Documentation Committee (IKDC) | Patient reported outcome measures of symptoms, sports activity & knee function. 0-100 points with 0 (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms) | 1 year | 
| Marx Activity Rating Score | Clinical Outcomes | 1 year | 
| Side to side difference in anterior tibial translation | Anterior tibial translation measured by (Knee laxity Testing device) KT-1000 Arthrometer | 6 weeks, 3 months, 6 months, 9 months, 1 year |