Effectiveness of a home-based re-injury prevention program on motor control, return to sport and recurrence rates after anterior cruciate ligament reconstruction: study protocol for a multicenter, single-blind, randomized controlled trial (PReP)

Trials

Andree Ellermann¹  Atesch Ateschrang²  Tobias M. Jung³  Ralph Akoto⁴  Alexander Barié⁵  Andrea Achtnich⁶  Daniel Guenther⁷  Raymond Best⁸  Andreas Fischer⁹  Daniel Niederer^1,10  Winfried Banzer^1,10  Thomas Stein^1,11  Frederic Welsch^1,11  Thomas Stoffels^1,12  Mirco Herbort^1,13  Matthias Krause^1,14  Maren Janko^1,15  Wolf Petersen^1,16  Matthias Keller^1,17  Amelie Stöhr^1,18  Jürgen Höher^1,19 

[1] Arcus Sportklinik;BG Trauma Center Tübingen, Eberhard Karls University Tübingen;Center for Musculoskeletal Surgery, Charité-University Medicine Berlin;Chirurgisch-Traumatologisches Zentrum, Asklepios Klinik St. Georg;Clinic for Orthopedics and Trauma Surgery, Center for Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital;Department for Orthopaedic Sports Medicine, Klinikum rechts der Isar;Department of Orthopaedic Surgery, Trauma Surgery, and Sports Medicine, Cologne Merheim Medical Center, Witten/Herdecke University;Department of Orthopaedic and Trauma Surgery, Sportklinik Stuttgart;Department of Orthopedic Surgery, Physical Medicine and Rehabilitation, University Hospital, Ludwig-Maximilians-University (LMU);Department of Sports Medicine, Goethe University Frankfurt;Department of Sporttraumatology, Knee, and Shoulder Surgery, Berufsgenossenschaftliche Unfallklinik Frankfurt am Main;Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Marzahn;Department of Trauma, Hand and Reconstructive Surgery, University Hospital Muenster;Department of Trauma, Hand and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf;Department of Trauma, Hand, and Reconstructive Surgery, Goethe-University Frankfurt;Klinik für Orthopädie und Unfallchirurgie;OSINSTITUT;Orthopedic Surgery Munich;Sports Clinic Cologne at Cologne Merheim Medical Center, Cologne, University of Witten/Herdecke;

关键词: Return to sports;    Return to play;    RTS;    Recurrence;    Re-injury;    ACL;   

DOI  :  10.1186/s13063-019-3610-2

来源: DOAJ

【 摘 要 】

Abstract Background Although anterior cruciate ligament (ACL) tear-prevention programs may be effective in the (secondary) prevention of a subsequent ACL injury, little is known, yet, on their effectiveness and feasibility. This study assesses the effects and implementation capacity of a secondary preventive motor-control training (the Stop-X program) after ACL reconstruction. Methods and design A multicenter, single-blind, randomized controlled, prospective, superiority, two-arm design is adopted. Subsequent patients (18–35 years) with primary arthroscopic unilateral ACL reconstruction with autologous hamstring graft are enrolled. Postoperative guideline rehabilitation plus Classic follow-up treatment and guideline rehabilitation plus the Stop-X intervention will be compared. The onset of the Stop-X program as part of the postoperative follow-up treatment is individualized and function based. The participants must be released for the training components. The endpoint is the unrestricted return to sport (RTS) decision. Before (where applicable) reconstruction and after the clearance for the intervention (aimed at 4–8 months post surgery) until the unrestricted RTS decision (but at least until 12 months post surgery), all outcomes will be assessed once a month. Each participant is consequently measured at least five times to a maximum of 12 times. Twelve, 18 and 24 months after the surgery, follow-up-measurements and recurrence monitoring will follow. The primary outcome assessement (normalized knee-separation distance at the Drop Jump Screening Test (DJST)) is followed by the functional secondary outcomes assessements. The latter consist of quality assessments during simple (combined) balance side, balance front and single-leg hops for distance. All hop/jump tests are self-administered and filmed from the frontal view (3-m distance). All videos are transferred using safe big content transfer and subsequently (and blinded) expertly video-rated. Secondary outcomes are questionnaires on patient-reported knee function, kinesiophobia, RTS after ACL injury and training/therapy volume (frequency – intensity – type and time). All questionnaires are completed online using the participants’ pseudonym only. Group allocation is executed randomly. The training intervention (Stop-X arm) consists of self-administered home-based exercises. The exercises are step-wise graduated and follow wound healing and functional restoration criteria. The training frequency for both arms is scheduled to be three times per week, each time for a 30 min duration. The program follows current (secondary) prevention guidelines. Repeated measurements gain-score analyses using analyses of (co-)variance are performed for all outcomes. Trial registration German Clinical Trials Register, identification number DRKS00015313. Registered on 1 October 2018.

【 授权许可】

Unknown