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

August 30, 2020 updated by: Andri Maruli Tua Lubis, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 36 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BQT Group
Procedure on this arm = bone quadriceps tendon reconstruction
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
Other: SBHT Group
Procedure on this arm = single-bundle hamstring tendon reconstruction
Procedure: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Comparator for New Reconstruction Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes (Improvement) of Rolimeter Measurement After Procedure
Time Frame: Measurement 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
Measurement in 1 year after operation
Changes (Improvement) of PRO Questionnaire After Procedure
Time Frame: PRO 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
PRO was taken in a period of 1 year after surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

November 17, 2017

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

August 30, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 30, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BQT-SBHT-FMUI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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