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Measurements for a safe return to sports after ACL reconstruction.

- candidate number15299
- NTR NumberNTR4130
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-aug-2013
- Secondary IDsN/A 
- Public TitleMeasurements for a safe return to sports after ACL reconstruction.
- Scientific TitlePredictive validity of a functional performance test battery for a safe return to sports after ACL reconstruction.
- hypothesisThe aim of this study is to correlate the score on a functional performance test battery to the occurence of ACL reruptures and contralateral ruptures. We hypothesize that athletes with a limb symmetry index of <100% on strength or hoptests or a bad quality of movement have more risk for graft rerupture or contralateral rupture.
- Healt Condition(s) or Problem(s) studiedAnterior cruciate ligament, Anterior cruciate ligament reconstruction (ACLR), Anterior cruciate ligament rupture
- Inclusion criteria- ACLR from September 2013 untill December 2014
- 16-40 years old, male and female
- Athletes with preoperative Tegner Activity scale >= 6 (only pivoting sports)
- Any arthroscopic surgical method for ACLR with bone-patellar tendon-bone or semitendinosus/gracilis autograft
- All fixation methods
- Concomitant ligament injury (MCL, LCL, PCL, posterolateral corner) grade A or B (IKDC criteria)
- Concomitant meniscectomy
- Cartilage pathology grade I or II (ICRS criteria)
- Patient is willing to rehabilitate at a physiotherapy practice that is a member of the hospitals network
- Patients willing to sign informed consent
- Exclusion criteria- Autograft or synthetic graft
- Revision surgery
- Meniscal repairr
- Concomitant ligament injury C of D
- Cartilage pathology grade III or IV
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2014
- planned closingdate31-dec-2017
- Target number of participants150
- InterventionsThe rehabilitation after ACLR will follow the KNGF Evidence Statement (that will be published in the fall of 2013). Measurement of functional performance are according to the Evidence Statement. The measurements include both quantity and quality of functional performance: strength measurements, hoptest battery, video-analysis for quality of movement during drop jump. Before surgery and after finishing rehabilitation, only an online questionnaire is send, with questions about return to sports and injuries.
- Primary outcome- Number of graft reruptures and contralateral ACL ruptures two years after ACLR, comparison between subgroups based on limb symmetry index score or qualitative performance.
- Number of injuries at lower limb two years after ACLR, comparison between subgroups based on limb symmetry index score or qualitative performance.
- Secondary outcome- Number of athletes that returned to preinjury sport level two years after ACLR, comparison between subgroups based on limb symmetry index score or qualitative performance.
- Duration of rehabilitation related to preoperative scores.
- TimepointsMeasurements are conducted at the following timepoints:
T0 preoperative
T1 at the end of the first postoperative phase
T2 at the end of the second postoperative phase
T3 at the end of the third postoperative phase
T4 1 year postoperative
T5 1 year and 3 months postoperative
T6 1 year and 6 months postoperative
T7 1 year and 9 months postoperative
T8 2 years postoperative
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPT, MSc Nicky Engelen-van Melick
- CONTACT for SCIENTIFIC QUERIESPT, MSc Nicky Engelen-van Melick
- Sponsor/Initiator Sport Medisch Centrum Papendal, University Medical Center St. Radboud, IQ healthcare, Rijnstate Ziekenhuis, Kliniek ViaSana
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center St. Radboud, Rijnstate Hospital
- PublicationsIntention of publication of study protocol within one year time and of study results after the study is finished.
- Brief summaryFor athletes rehabilitation after anterior cruciate ligament reconstruction (ACLR) could be judged successful if they return to their previous level of sports. Recent research, however, shows that one third of athletes does not return to this sport level within two years. After three or more years this number even increases to 50%. Half of these athletes report their ACL injury as the primary reason for a lower activity level. Moreover, athletes that do return to their previous sport level have a considerable risk of tearing the graft or the contralateral ACL within the first two years; 3-22% of athletes rerupture the reconstructed ligament and 3-24% rupture the contralateral ACL. The risk of a contralateral ACL injury is higher when returning to a high level of pivoting sports. Three recent systematic reviews show that most clinicians do not use objective criteria for determining the moment of return to sports. Furthermore, there are no measurements for quality of movement performed, despite previous studies showed that, besides quantity, also quality of movement can be a causal factor for ACL (re)ruptures. The presence of dynamic knee valgus when landing from a jump and deficits in neuromuscular control of the trunk can predict ACL injury in healthy athletes. Also, the occurrence of dynamic knee valgus and a smaller knee flexion angle during landing are predictive for ACL rerupture. It can be concluded that both components of functional performance are important in rehabilitation after ACLR and prevention of (re)injuries. Nevertheless, there has never been conducted a prospective cohort study with ACLR athletes, to investigate whether an extensive test battery for measuring quantity and quality of movement is able to predict safe return to sports.
- Main changes (audit trail)
- RECORD20-aug-2013 - 18-jul-2014

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