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Clinical Trials/NCT04058574
NCT04058574
Unknown
Not Applicable

Measurement and Relationships of Proprioceptive Isokinetic Repositioning With Muscle Strength, Functional Testing, and Self-reported Questionaires Before and After Anterior Cruciate Ligament Reconstruction: A Prospective Study With 12-months Post Operative Follow-up.

University Hospital, Caen1 site in 1 country45 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL Tear
Sponsor
University Hospital, Caen
Enrollment
45
Locations
1
Primary Endpoint
Change from Baseline passive proprioceptive evaluation after 7 months
Last Updated
5 years ago

Overview

Brief Summary

This prospectively study aims to evaluate the evolution of knee joint proprioception on isokinetic dynamometer before and after Anterior Cruciate Ligament (ACL) reconstruction and its relationships with muscle strength, self reported questionnaire and return to sport. This study will include 30 athletes with isolated ACL rupture, and treated with ACL reconstruction surgery and 15 healthy volunteers.

Detailed Description

Anterior cruciate ligament (ACL) rupture is a common injury in athletes. It has multiple consequences on the knee: instability, pain, loss of muscle strength, proprioceptive impairments, modification of the knee kinematics and premature knee osteoarthritis. In athletes, the majority of these injuries are treated with ACL reconstruction surgery. The main objective of this treatment is the reduction of knee instability to allow return to sport, and this at the same level prior to the injury. Thus, the athlete's follow-up after the surgery is essential to guide the return to sport and to ensure that the knee sensorimotor control allows the return to sport. Currently this assessment is based primarily on functional testings and measurement of muscle strength. The investigators propose to prospectively study the evolution of instrumentally measured knee proprioception using isokinetic dynamometer before and after ACL reconstruction as well as a study of the factors associated with its favorable evolution and its impact in the return to sport and its level.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
January 1, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joffrey DRIGNY

Chief Resident PM&R and Sport departments MD, MSc

University Hospital, Caen

Eligibility Criteria

Inclusion Criteria

  • Isolated and primary tear of the ACL
  • Individual candidate for an ACL reconstruction surgery.
  • Acute ACL injury (\<6 weeks)
  • Athletes (person who competes in one or more sports that involve physical strength, speed or endurance) whatever their level of sport practice
  • Internet access

Exclusion Criteria

  • Prior knee surgery
  • Complex ligamentous lesion (lateral ligaments, posterior cruciate ligament)
  • Surgery for meniscal lesions (patients initially included but warranting meniscal surgery during arthroscopy will be secondarily excluded from the study.)
  • Recent muscle damage
  • History of significant injury on the healthy knee
  • ACL rupture recurrence
  • Pregnant woman
  • Neurological or vestibular antecedent with sequelae
  • Individuals taking treatment altering alertness (neuroleptics, sedatives)
  • Informed consent not obtained

Outcomes

Primary Outcomes

Change from Baseline passive proprioceptive evaluation after 7 months

Time Frame: ACL group: 6 weeks after surgery and 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year

Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.

Change from Baseline active proprioceptive evaluation after 7 months

Time Frame: ACL group: 6 weeks after surgery and 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year

Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.

Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 months

Time Frame: ACL group: 6 weeks after surgery and 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year

Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.

Secondary Outcomes

  • Strength(ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year)
  • ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)(ACL group: Four evaluations on both injured and healthy knees: (1) 2 weeks before surgery, (2) 3 months after surgery, (3) 7 months after surgery and (4) 12 months after surgery)
  • Functional testing(ACL group: Two evaluations on both injured and healthy knees: (1) 3 months after surgery and (2) 7 months after surgery; Healthy group: one evaluation at a single point in time through study completion, an average of 1 year)

Study Sites (1)

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