Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

NCT ID: NCT04536246

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-11-17

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.

Conditions

Sports Injury; Anterior Cruciate Ligament Rupture

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BQT Group

Procedure on this arm = bone quadriceps tendon reconstruction

Group Type: ACTIVE_COMPARATOR

Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction

Intervention Type: PROCEDURE

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

SBHT Group

Procedure on this arm = single-bundle hamstring tendon reconstruction

Group Type: OTHER

Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction

Intervention Type: PROCEDURE

Comparator for New Reconstruction Technique

Interventions

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

Intervention Type: PROCEDURE

Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction

Comparator for New Reconstruction Technique

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Andri Maruli Tua Lubis

Head of Orthopaedic Sports and Arthroscopy Division, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 28273424 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27365373 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27209621 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22925587 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20149574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16909301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22588746 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19454278 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24379730 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 15124660 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19797565 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22340342 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23302260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16131675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11041586 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11354857 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16172862 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10470905 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15483539 (View on PubMed)

Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. doi: 10.1177/0363546505279922.

Reference Type: BACKGROUND

PMID: 16230470 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24191878 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21311861 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24305648 (View on PubMed)

Other Identifiers

BQT-SBHT-FMUI

Identifier Type: -

Identifier Source: org_study_id