search
Back to results

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
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sports Injury focused on measuring ACL reconstruction, Arthroscopic-assisted, BQT, SBHT

Eligibility Criteria

15 Years - 40 Years (Child, Adult)All SexesAccepts 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

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

    First Posted
    July 16, 2020
    Last Updated
    August 30, 2020
    Sponsor
    Indonesia University
    search

    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

    Citations:
    PubMed Identifier
    28273424
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27365373
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27209621
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22925587
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20149574
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16909301
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22588746
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19454278
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24379730
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15124660
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19797565
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22340342
    Citation
    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.
    Results Reference
    background
    Citation
    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
    Results Reference
    background
    PubMed Identifier
    23302260
    Citation
    Collins JE, Katz JN, Donnell-Fink LA, Martin SD, Losina E. Cumulative incidence of ACL reconstruction after ACL injury in adults: role of age, sex, and race. Am J Sports Med. 2013 Mar;41(3):544-9. doi: 10.1177/0363546512472042. Epub 2013 Jan 9.
    Results Reference
    background
    PubMed Identifier
    16131675
    Citation
    Tow BP, Chang PC, Mitra AK, Tay BK, Wong MC. Comparing 2-year outcomes of anterior cruciate ligament reconstruction using either patella-tendon or semitendinosus-tendon autografts: a non-randomised prospective study. J Orthop Surg (Hong Kong). 2005 Aug;13(2):139-46. doi: 10.1177/230949900501300206.
    Results Reference
    background
    PubMed Identifier
    11041586
    Citation
    Deehan DJ, Salmon LJ, Webb VJ, Davies A, Pinczewski LA. Endoscopic reconstruction of the anterior cruciate ligament with an ipsilateral patellar tendon autograft. A prospective longitudinal five-year study. J Bone Joint Surg Br. 2000 Sep;82(7):984-91. doi: 10.1302/0301-620x.82b7.10573.
    Results Reference
    background
    PubMed Identifier
    11354857
    Citation
    Panni AS, Milano G, Tartarone M, Demontis A, Fabbriciani C. Clinical and radiographic results of ACL reconstruction: a 5- to 7-year follow-up study of outside-in versus inside-out reconstruction techniques. Knee Surg Sports Traumatol Arthrosc. 2001;9(2):77-85. doi: 10.1007/s001670000171.
    Results Reference
    background
    PubMed Identifier
    16172862
    Citation
    Dargel J, Schmidt-Wiethoff R, Schneider T, Bruggemann GP, Koebke J. Biomechanical testing of quadriceps tendon-patellar bone grafts: an alternative graft source for press-fit anterior cruciate ligament reconstruction? Arch Orthop Trauma Surg. 2006 May;126(4):265-70. doi: 10.1007/s00402-005-0048-7. Epub 2005 Sep 17.
    Results Reference
    background
    PubMed Identifier
    10470905
    Citation
    Staeubli HU, Bollmann C, Kreutz R, Becker W, Rauschning W. Quantification of intact quadriceps tendon, quadriceps tendon insertion, and suprapatellar fat pad: MR arthrography, anatomy, and cryosections in the sagittal plane. AJR Am J Roentgenol. 1999 Sep;173(3):691-8. doi: 10.2214/ajr.173.3.10470905.
    Results Reference
    background
    PubMed Identifier
    15483539
    Citation
    Lee S, Seong SC, Jo H, Park YK, Lee MC. Outcome of anterior cruciate ligament reconstruction using quadriceps tendon autograft. Arthroscopy. 2004 Oct;20(8):795-802. doi: 10.1016/j.arthro.2004.06.009.
    Results Reference
    background
    Citation
    BD B, RJ J, JA A, BC F, CE N. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med [Internet]. 2005;33(11):1751-67. Available from: http://search.ebscohost.com/login.aspx?direct=true&db=rzh&AN=106381336&site=ehost-live
    Results Reference
    background
    PubMed Identifier
    24191878
    Citation
    Sofu H, Sahin V, Gursu S, Yildirim T, Issin A, Ordueri M. Use of quadriceps tendon versus hamstring tendon autograft for arthroscopic anterior cruciate ligament reconstruction: a comparative analysis of clinical results. Eklem Hastalik Cerrahisi. 2013;24(3):139-43. doi: 10.5606/ehc.2013.31.
    Results Reference
    background
    PubMed Identifier
    21311861
    Citation
    van Eck CF, Kropf EJ, Romanowski JR, Lesniak BP, Tranovich MJ, van Dijk CN, Fu FH. Factors that influence the intra-articular rupture pattern of the ACL graft following single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1243-8. doi: 10.1007/s00167-011-1427-y. Epub 2011 Feb 11.
    Results Reference
    background
    PubMed Identifier
    24305648
    Citation
    Ramski DE, Kanj WW, Franklin CC, Baldwin KD, Ganley TJ. Anterior cruciate ligament tears in children and adolescents: a meta-analysis of nonoperative versus operative treatment. Am J Sports Med. 2014 Nov;42(11):2769-76. doi: 10.1177/0363546513510889. Epub 2013 Dec 4.
    Results Reference
    background

    Learn more about this trial

    Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

    We'll reach out to this number within 24 hrs