ClinicalTrials.Veeva

Menu

Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction (BQTSBHTFMUI)

U

University of Indonesia (UI)

Status

Completed

Conditions

Sports Injury
Anterior Cruciate Ligament Rupture

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04536246
BQT-SBHT-FMUI

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

BQT Group
Active Comparator group
Description:
Procedure on this arm = bone quadriceps tendon reconstruction
Treatment:
Procedure: Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction
SBHT Group
Other group
Description:
Procedure on this arm = single-bundle hamstring tendon reconstruction
Treatment:
Procedure: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems