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Sports InjuryBQTSBHTFMUINCT04536246

Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

A study testing Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction and Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction in people with Sports Injury and Anterior Cruciate Ligament Rupture, run by Universitas Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 40 yearsHealthy volunteers can take part
What is being tested?
Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction and Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Feb 2015to 17 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Unilateral, total rupture of ACL
  • Procedure performed by the same surgeon
  • Age of subjects between 15-40 years old

Who cannot join

  • Multiligamentous injury
  • Bilateral ACL ruptures
  • Ligamentous laxity
  • Prior knee ligamentous surgery

About this study

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

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.

Read the 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.

Being tested
Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction, Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Keywords
ACL reconstruction, Arthroscopic-assisted, BQT, SBHT
Medical subject headings
Athletic Injuries, Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstructionProcedure or surgery

    New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment

  • Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstructionProcedure or surgery

    Comparator for New Reconstruction Technique

Study groups in NCT04536246
Study groupRoleWhat they receive
BQT GroupActive comparatorProcedure on this arm = bone quadriceps tendon reconstruction
Receives: Procedure: Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction
SBHT GroupOtherProcedure on this arm = single-bundle hamstring tendon reconstruction
Receives: Procedure: Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes (Improvement) of Rolimeter Measurement After Procedure

    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

    Measured: Measurement in 1 year after operation

  2. Changes (Improvement) of PRO Questionnaire After 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

    Measured: PRO was taken in a period of 1 year after surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2020
  2. Study start1 Feb 2015
  3. Primary completion28 Feb 2017
  4. Study completion17 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
multi-site study 15 subjects on each group analysis
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04536246
Sponsor's protocol ID
BQT-SBHT-FMUI
Acronym
BQTSBHTFMUI
Status last verified
Aug 2020
First submitted
16 Jul 2020
Last updated
2 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cavaignac E, Coulin B, Tscholl P, Nik Mohd Fatmy N, Duthon V, Menetrey J. Is Quadriceps Tendon Autograft a Better Choice Than Hamstring Autograft for Anterior Cruciate Ligament Reconstruction? A Comparative Study With a Mean Follow-up of 3.6 Years. Am J Sports Med. 2017 May;45(6):1326-1332. doi: 10.1177/0363546516688665. Epub 2017 Mar 8.

    PubMed 28273424

  • Lee JK, Lee S, Lee MC. Outcomes of Anatomic Anterior Cruciate Ligament Reconstruction: Bone-Quadriceps Tendon Graft Versus Double-Bundle Hamstring Tendon Graft. Am J Sports Med. 2016 Sep;44(9):2323-9. doi: 10.1177/0363546516650666. Epub 2016 Jun 30.

    PubMed 27365373

  • Haner M, Bierke S, Petersen W. Anterior Cruciate Ligament Revision Surgery: Ipsilateral Quadriceps Versus Contralateral Semitendinosus-Gracilis Autografts. Arthroscopy. 2016 Nov;32(11):2308-2317. doi: 10.1016/j.arthro.2016.03.020. Epub 2016 May 18.

    PubMed 27209621

  • Akoto R, Hoeher J. Anterior cruciate ligament (ACL) reconstruction with quadriceps tendon autograft and press-fit fixation using an anteromedial portal technique. BMC Musculoskelet Disord. 2012 Aug 27;13:161. doi: 10.1186/1471-2474-13-161.

    PubMed 22925587

  • Yue B, Varadarajan KM, Ai S, Tang T, Rubash HE, Li G. Differences of knee anthropometry between Chinese and white men and women. J Arthroplasty. 2011 Jan;26(1):124-30. doi: 10.1016/j.arth.2009.11.020. Epub 2010 Feb 9.

    PubMed 20149574

  • Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.

    PubMed 16909301

  • Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.

    PubMed 22588746

  • Bekkers JE, de Windt TS, Raijmakers NJ, Dhert WJ, Saris DB. Validation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) for the treatment of focal cartilage lesions. Osteoarthritis Cartilage. 2009 Nov;17(11):1434-9. doi: 10.1016/j.joca.2009.04.019. Epub 2009 May 7.

    PubMed 19454278

  • Schulz AP, Lange V, Gille J, Voigt C, Frohlich S, Stuhr M, Jurgens C. Anterior cruciate ligament reconstruction using bone plug-free quadriceps tendon autograft: intermediate-term clinical outcome after 24-36 months. Open Access J Sports Med. 2013 Nov 19;4:243-9. doi: 10.2147/OAJSM.S49223. eCollection 2013.

    PubMed 24379730

  • Mologne T, Friedman M. Arthroscopic anterior cruciate reconstruction with hamstring tendons: indications, surgical technique, and complications and their treatment. In: Insall & Scott Surgery of the Knee. 4th ed. Philadelphia: Elsevier Inc; 2006.

  • Chen V, Hunter R, Woolf J. Anterior Cruciate Ligament Injuries. In: Schepsis A, Busconi B, editors. Orthopaedic Surgery Essential - Sports Medicine. Philadelphia: Lippincott Williams & Wilkins; 2006.

  • Pavlovich R Jr, Goldberg SH, Bach BR Jr. Adolescent ACL injury: treatment considerations. J Knee Surg. 2004 Apr;17(2):79-93. doi: 10.1055/s-0030-1248203.

    PubMed 15124660

  • Lyman S, Koulouvaris P, Sherman S, Do H, Mandl LA, Marx RG. Epidemiology of anterior cruciate ligament reconstruction: trends, readmissions, and subsequent knee surgery. J Bone Joint Surg Am. 2009 Oct;91(10):2321-8. doi: 10.2106/JBJS.H.00539.

    PubMed 19797565

  • Shi DL, Yao ZJ. Knee function after anterior cruciate ligament reconstruction with patellar or hamstring tendon: a meta-analysis. Chin Med J (Engl). 2011 Dec;124(23):4056-62.

    PubMed 22340342

  • Peter Layde SLC, Layde P, Guse CE, Schlotthauer AE, Valin SE Van. The Incidence and Etiology of Anterior Cruciate Ligament Injuries in Patients under the Age of 18 in the State of Wisconsin. Pediatr Ther [Internet]. 2014;04(02). Available from: https://www.omicsonline.org/open-access/the-incidence-and-etiology-of-anterior-cruciate-ligament-injuries-in-patients-under-the-age-of-in-the-state-of-wisconsin-2161-0665.1000196.php?aid=26065

Questions about this trial

What is this clinical trial studying?

A study testing Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction and Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction in people with Sports Injury and Anterior Cruciate Ligament Rupture, run by Universitas Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes (Improvement) of Rolimeter Measurement After Procedure (time frame: Measurement in 1 year after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04536246, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.

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