Anterior Cruciate Ligament Rupture, Sports Injury
Conditions
Keywords
ACL reconstruction, Arthroscopic-assisted, BQT, SBHT
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.
Interventions
PROCEDUREBone 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
PROCEDURESingle-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Comparator for New Reconstruction Technique
Sponsors
Indonesia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
multi-site study 15 subjects on each group analysis
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes (Improvement) of Rolimeter Measurement After Procedure | 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 |
| Changes (Improvement) of PRO Questionnaire After Procedure | 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 |
Outcome results
None listed