Functional Outcome Comparison of Implant-Free Bone-Patellar Tendon Autograft in Arthroscopic ACL Reconstruction
NCT ID: NCT04123834
Last Updated: 2019-10-11
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2013-03-01
2014-03-30
Brief Summary
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Detailed Description
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Materials and Methods: A prospective cohort study design was used. Between March 2013 and March 2014, 12 patients underwent implantless ACL reconstruction using press-fit femoral technique, while 24 patients underwent implant ACL reconstruction. Objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to IKDC, Tegner-Lysholm and KOOS.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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implantless Arthroscopic ACL reconstruction
implantless Arthroscopic ACL reconstruction using press-fit femoral technique
Patella tendon & bone block autograft + press-fit femoral technique
Implantless Arthroscopic ACL reconstruction using press-fit femoral technique The investigator's study uses the press-fit graft fixation technique by Edgar Michael. A midline skin incision was made that extends from inferior pole of patella up to anterior tibial tuberosity. Patella tendon with tibial tuberosity bone block were harvested, patella bone was left intact. The tendon was fixed together with non-absorbable suture.
Arthroscopic ACL reconstruction
Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)
Arthroscopic ACL reconstruction with implant
ACL reconstruction with implant (hamstring autograft fixed with bioscrew and endo-button)
Arthroscopic ACL reconstruction
Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)
Hamstring tendon autograft + implant fixation
Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)
Interventions
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Patella tendon & bone block autograft + press-fit femoral technique
Implantless Arthroscopic ACL reconstruction using press-fit femoral technique The investigator's study uses the press-fit graft fixation technique by Edgar Michael. A midline skin incision was made that extends from inferior pole of patella up to anterior tibial tuberosity. Patella tendon with tibial tuberosity bone block were harvested, patella bone was left intact. The tendon was fixed together with non-absorbable suture.
Arthroscopic ACL reconstruction
Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)
Hamstring tendon autograft + implant fixation
Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* previous history of knee surgery
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Andri Maruli Tua Lubis
Principal Investigator
Principal Investigators
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Andri MT Lubis, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
References
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Biau DJ, Tournoux C, Katsahian S, Schranz PJ, Nizard RS. Bone-patellar tendon-bone autografts versus hamstring autografts for reconstruction of anterior cruciate ligament: meta-analysis. BMJ. 2006 Apr 29;332(7548):995-1001. doi: 10.1136/bmj.38784.384109.2F. Epub 2006 Apr 7.
Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797.
Romanini E, D'Angelo F, De Masi S, Adriani E, Magaletti M, Lacorte E, Laricchiuta P, Sagliocca L, Morciano C, Mele A. Graft selection in arthroscopic anterior cruciate ligament reconstruction. J Orthop Traumatol. 2010 Dec;11(4):211-9. doi: 10.1007/s10195-010-0124-9. Epub 2010 Dec 23.
Remer EM, Fitzgerald SW, Friedman H, Rogers LF, Hendrix RW, Schafer MF. Anterior cruciate ligament injury: MR imaging diagnosis and patterns of injury. Radiographics. 1992 Sep;12(5):901-15. doi: 10.1148/radiographics.12.5.1529133.
Tirmik U, Mahirogullari M, Kuskucu M. The results of reconstruction of the ACL using the cross-pin femoral system and four-strand hamstring tendon autografts. Acta Orthop Traumatol Turc. 2011;45(4):233-9. doi: 10.3944/AOTT.2011.2309.
Mei Y, Ao YF, Wang JQ, Ma Y, Zhang X, Wang JN, Zhu JX. Clinical characteristics of 4355 patients with anterior cruciate ligament injury. Chin Med J (Engl). 2013 Dec;126(23):4487-92.
Taketomi S, Inui H, Yamagami R, Shirakawa N, Kawaguchi K, Nakagawa T, Tanaka S. Bone-Patellar Tendon-Bone Autograft versus Hamstring Tendon Autograft for Anatomical Anterior Cruciate Ligament Reconstruction with Three-Dimensional Validation of Femoral and Tibial Tunnel Positions. J Knee Surg. 2018 Oct;31(9):866-874. doi: 10.1055/s-0037-1615813. Epub 2017 Dec 28.
Pavlik A, Hidas P, Tallay A, Toman J, Berkes I. Femoral press-fit fixation technique in anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: a prospective clinical evaluation of 285 patients. Am J Sports Med. 2006 Feb;34(2):220-5. doi: 10.1177/0363546505279920. Epub 2005 Oct 6.
Noyes FR, Barber-Westin SD. Treatment of meniscus tears during anterior cruciate ligament reconstruction. Arthroscopy. 2012 Jan;28(1):123-30. doi: 10.1016/j.arthro.2011.08.292. Epub 2011 Nov 9.
Widuchowski W, Widuchowska M, Koczy B, Dragan S, Czamara A, Tomaszewski W, Widuchowski J. Femoral press-fit fixation in ACL reconstruction using bone-patellar tendon-bone autograft: results at 15 years follow-up. BMC Musculoskelet Disord. 2012 Jun 27;13:115. doi: 10.1186/1471-2474-13-115.
Wipfler B, Donner S, Zechmann CM, Springer J, Siebold R, Paessler HH. Anterior cruciate ligament reconstruction using patellar tendon versus hamstring tendon: a prospective comparative study with 9-year follow-up. Arthroscopy. 2011 May;27(5):653-65. doi: 10.1016/j.arthro.2011.01.015.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Press-Fit ACL
Identifier Type: -
Identifier Source: org_study_id
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