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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction | New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment |
| PROCEDURE | Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction | Comparator 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.