Clinical Trials Directory

Trials / Completed

CompletedNCT04536246

Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
All
Age
15 Years – 40 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstructionNew intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment
PROCEDURESingle-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstructionComparator for New Reconstruction Technique

Timeline

Start date
2015-02-01
Primary completion
2017-02-28
Completion
2017-11-17
First posted
2020-09-02
Last updated
2020-09-02

Source: ClinicalTrials.gov record NCT04536246. Inclusion in this directory is not an endorsement.