Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

Study Overview
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Brief Summary
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ACL rupture has a high morbidity in productive-age population. The increasing incidence and proper management has become a point of interest in the musculoskeletal sport injury. Choosing the best graft has become the main focus in searching for a better outcome regarding ACL reconstruction in these patient population. Currently, single bundle hamstring tendon (SBHT) autograft was preferred in Asian population compared to bone quadriceps tendon (BQT) autograft. However, there are some problems such as smaller size, as well as diameter, of SBHT. This study is focused on evaluation of the clinical outcome between BQT and SBHT in arthroscopic-assisted ACL reconstruction patients.

Detailed Description
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In this prospective cohort study, 30 subjects were divided into 2 groups (BQT and SBHT). Sampling was taken between February 2016-2017 (1 year) in one orthopaedic center. The instruments used for evaluation are rolimeter and PRO questionnaires (IKDC, Tegner-Lysholm, and KOOS) with data mining between 1 month, 3 months, and 6 months post operation. To obtain a valid and accountable research data, the investigators collected the information based on 2 parameters and then crosschecked the results. After clinical data was obtained, the investigators translate the results into a statistical data using SPSS ver.24 and simplified the data for national registry and academic purposes. According to previous studies, and research hypothesis, functional outcome of patient undergoing arthroscopic-assisted ACL reconstruction is better in BQT group compared to SBHT group, both in subjective and objective parameters given.

Official Title
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Comparison of Functional Outcome Between Bone Quadriceps Tendon (BQT) and Single-Bundle Hamstring Tendon (SBHT) Autograft in Arthroscopic-assissted Anterior Cruciate Ligament Reconstruction: a Prospective Cohort Study

Conditions
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Sports Injury, Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Procedure: Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction
* Procedure: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral, total rupture of ACL Procedure performed by the same surgeon Age of subjects between 15-40 years old Exclusion Criteria: Multiligamentous injury Bilateral ACL ruptures Ligamentous laxity Prior knee ligamentous surgery

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multi-site study 15 subjects on each group analysis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BQT Group<br>Procedure on this arm = bone quadriceps tendon reconstruction | Procedure: Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction<br>* New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment<br>|
| Other: SBHT Group<br>Procedure on this arm = single-bundle hamstring tendon reconstruction | Procedure: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction<br>* Comparator for New Reconstruction Technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes (Improvement) of Rolimeter Measurement After Procedure | Rolimeter measurement is the objective outcome expected in this study This device was calibrated and tested prior to the usage in the study Literature review --> no significant difference between KT1000/2000 and rolimeter for measuring antero-posterior translation of the knee joint | Measurement in 1 year after operation | 
| Changes (Improvement) of PRO Questionnaire After Procedure | We use three different PRO to make an accountable subjective outcome No standard PRO questionnaire for ACL cases; we used three to be able to triangulate the mean subjective outcome Rationale for using three PRO : these PROs were rapidly used in other similar studies around the world, had good and reliable results, and contains categoric and numeric data for statistical computation and interpretation | PRO was taken in a period of 1 year after surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BQT, ACL reconstruction, Arthroscopic-assisted, SBHT