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Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

Not Applicable
Completed
Conditions
Sports Injury
Anterior Cruciate Ligament Rupture
Interventions
Procedure: Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction
Procedure: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Registration Number
NCT04536246
Lead Sponsor
Indonesia University
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BQT GroupBone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstructionProcedure on this arm = bone quadriceps tendon reconstruction
SBHT GroupSingle-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstructionProcedure on this arm = single-bundle hamstring tendon reconstruction
Primary Outcome Measures
NameTimeMethod
Changes (Improvement) of Rolimeter Measurement After ProcedureMeasurement in 1 year after operation

1. Rolimeter measurement is the objective outcome expected in this study

2. This device was calibrated and tested prior to the usage in the study

3. Literature review --\> no significant difference between KT1000/2000 and rolimeter for measuring antero-posterior translation of the knee joint

Changes (Improvement) of PRO Questionnaire After ProcedurePRO was taken in a period of 1 year after surgical procedure

1. We use three different PRO to make an accountable subjective outcome

2. No standard PRO questionnaire for ACL cases; we used three to be able to triangulate the mean subjective outcome

3. 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

Secondary Outcome Measures
NameTimeMethod
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