Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction (BQTSBHTFMUI)
Primary Purpose
Sports Injury, Anterior Cruciate Ligament Rupture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction
Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Sponsored by
About this trial
This is an interventional treatment trial for Sports Injury focused on measuring ACL reconstruction, Arthroscopic-assisted, BQT, SBHT
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
BQT Group
SBHT Group
Arm Description
Procedure on this arm = bone quadriceps tendon reconstruction
Procedure on this arm = single-bundle hamstring tendon reconstruction
Outcomes
Primary Outcome Measures
Changes (Improvement) of Rolimeter Measurement After Procedure
Rolimeter measurement is the objective outcome expected in this study
This device was calibrated and tested prior to the usage in the study
Literature review --> no significant difference between KT1000/2000 and rolimeter for measuring antero-posterior translation of the knee joint
Changes (Improvement) of PRO Questionnaire After Procedure
We use three different PRO to make an accountable subjective outcome
No standard PRO questionnaire for ACL cases; we used three to be able to triangulate the mean subjective outcome
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04536246
Brief Title
Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction
Acronym
BQTSBHTFMUI
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2015 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Injury, Anterior Cruciate Ligament Rupture
Keywords
ACL reconstruction, Arthroscopic-assisted, BQT, SBHT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multi-site study 15 subjects on each group analysis
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BQT Group
Arm Type
Active Comparator
Arm Description
Procedure on this arm = bone quadriceps tendon reconstruction
Arm Title
SBHT Group
Arm Type
Other
Arm Description
Procedure on this arm = single-bundle hamstring tendon reconstruction
Intervention Type
Procedure
Intervention Name(s)
Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction
Intervention Description
New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment
Intervention Type
Procedure
Intervention Name(s)
Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Intervention Description
Comparator for New Reconstruction Technique
Primary Outcome Measure Information:
Title
Changes (Improvement) of Rolimeter Measurement After Procedure
Description
Rolimeter measurement is the objective outcome expected in this study
This device was calibrated and tested prior to the usage in the study
Literature review --> no significant difference between KT1000/2000 and rolimeter for measuring antero-posterior translation of the knee joint
Time Frame
Measurement in 1 year after operation
Title
Changes (Improvement) of PRO Questionnaire After Procedure
Description
We use three different PRO to make an accountable subjective outcome
No standard PRO questionnaire for ACL cases; we used three to be able to triangulate the mean subjective outcome
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
Time Frame
PRO was taken in a period of 1 year after surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
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Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction
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