title: MRI signal intensity of anterior cruciate ligament graft after transtibial versus anteromedial portal technique (TRANSIG): design of a randomized controlled clinical trial.
abstract: There are two primary surgical techniques to reconstruct the anterior cruciate ligament (ACL), transtibial (TT) technique and anteromedial portal (AMP) technique. Currently, there is no consensus which surgical technique elicits the best clinical and functional outcomes. MRI-derived measures of the signal intensity (SI) of the ACL graft have been described as an independent predictor of graft properties. The purpose of this study is to compare the MRI derived SI measurements of the ACL graft one year after ACL reconstruction, in order to compare the outcomes of both the AMP and TT ACL reconstruction technique.
  
  
  
  Thirty-six patients will be included in a randomized controlled trial. Patients who are admitted for primary unilateral ACL reconstruction will be included in the study. Exclusion criteria are a history of previous surgery on the ipsilateral knee, re-rupture of the ipsilateral ACL graft, associated ligamentous injuries or meniscal tear of the ipsilateral knee, unhealthy contralateral knee, contra-indications for MRI and a preference for one of the two surgical techniques and/or orthopaedic surgeon. Primary outcome is MRI Signal intensity ratio (SIR) of the ACL graft. Secondary outcome measures are the International Knee Documentation Committee (IKDC) Knee Examination Form,the Knee injury and Osteoarthritis Outcome Scores (KOOS) and the Anterior Cruciate Ligament OsteoArthritis Score (ACLOAS). Differences between MRI SIR assessment with the current MRI protocol (proton density weighted imaging protocol) and the additional T2*-weighted gradient-echo protocol will be assessed.
  
  
  
  There is no consensus regarding the TT or AMP ACL reconstruction technique. SI measurements with MRI have been used in other clinical studies for evaluation of the ACL graft and maturation after ACL reconstruction compared to clinical and functional outcomes. This randomized controlled trial has been designed to compare the TT technique with the AMP technique with the use of MRI SI of the graft after ACL reconstruction.
  
  
  
  Netherlands Trial Registry NTR5410 (registered on August 24, 2015).
authors: Department of Orthopaedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands.|Department of Technical Medicine, University of Twente, Enschede, The Netherlands.
authors: Simeon J S
authors: SJ
authors: Ruiter
authors: Department of Orthopaedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands.
authors: Reinoud W
authors: RW
authors: Brouwer
authors: Department of Radiology, Martini Hospital Groningen, Groningen, The Netherlands.
authors: Tim W G M
authors: TW
authors: Meys
authors: MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, The Netherlands.
authors: Cornelis H
authors: CH
authors: Slump
authors: Department of Orthopaedic Surgery, Martini Hospital Groningen, Groningen, The Netherlands. raayjjam@mzh.nl.
authors: Jos J A M
authors: JJ
authors: van Raay
mesh_terms: D000293:Adolescent; D000328:Adult; D016118:Anterior Cruciate Ligament / Q000000981:diagnostic imaging / Q000637:transplantation*; D000070598:Anterior Cruciate Ligament Injuries / Q000601:surgery*; D059549:Anterior Cruciate Ligament Reconstruction / Q000379:methods*; D006801:Humans; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D009426:Netherlands; D019737:Transplants / Q000000981:diagnostic imaging*; D016896:Treatment Outcome; D055815:Young Adult
keywords: ACL reconstruction; Anatomic; Graft signal intensity; MRI; Transtibial