Comparison of Functional Outcome Between BQT and SBHT ACL Reconstruction

Anterior Cruciate Ligament Rupture Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536246
• Other study ID #: BQT-SBHT-FMUI
• Status: Completed
• Phase: N/A
• Start date: February 1, 2015
• Est. completion date: November 17, 2017

Study information

• Verified date: August 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 17, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Athletic Injuries
• Rupture
• Sports Injury

Intervention

Procedure:
• 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
• Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction
Comparator for New Reconstruction Technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

References & Publications (26)

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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. — View 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.

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. — View 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:S208-28. doi: 10.1002/acr.20632. Review. — View Citation

Dargel J, Schmidt-Wiethoff R, Schneider T, Brüggemann 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. Epub 2005 Sep 17. — View Citation

Deehan DJ, Salmon LJ, Webb VJ, Davies A, Pinczewski LA. Endoscopic reconstruction of the anterior cruciate ligament with an ipsilateral patellar tendon autograft. J Bone Jt Surg - Ser B [Internet]. 2000;82(7):984-91. Available from: https://www.scopus.com/inward/record.uri?eid=2-s2.0-0033834074&doi=10.1302%2F0301-620X.82B7.10573&partnerID=40&md5=a6f5ce8ce5ff73d3c4a46c6aefbcafa3

Häner 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. — View 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. — View 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. — View 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.

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. — View Citation

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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

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S. L, S.C. S, H. J, Y.K. P, M.C. L. Outcome of anterior cruciate ligament reconstruction using quadriceps tendon autograft. Arthrosc - J Arthrosc Relat [Internet]. 2004;20(8):795-802. Available from: http://www.embase.com/search/results?subaction=viewrecord&from=export&id=L39335726%0Ahttp://dx.doi.org/10.1016/j.arthro.2004.06.009

Schulz AP, Lange V, Gille J, Voigt C, Fröhlich S, Stuhr M, Jürgens 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. — View 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. — View Citation

Sofu H, Sahin V, Gürsu 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. — View 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. — View 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. — View 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. — View Citation

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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. Epub 2006 Aug 15. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement in 1 year after operation
Primary	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	PRO was taken in a period of 1 year after surgical procedure