Clinical trial NCT04536246: Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Injury
Anterior Cruciate Ligament Rupture
Keywords: ACL reconstruction
Arthroscopic-assisted
BQT
SBHT
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-site study 15 subjects on each group analysis
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes (Improvement) of Rolimeter Measurement After Procedure
timeFrame: Measurement in 1 year after operation
measure: Changes (Improvement) of PRO Questionnaire After Procedure
timeFrame: PRO was taken in a period of 1 year after surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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