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Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction (PRO-ACL)

C

Caen University Hospital

Status

Unknown

Conditions

ACL Tear
ACL - Anterior Cruciate Ligament Deficiency

Treatments

Device: Proprioception measurement on isokinetic dynamometer

Study type

Interventional

Funder types

Other

Identifiers

NCT04058574
PRO-ACL

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 2 patient groups, including a placebo group

ACL
Active Comparator group
Description:
Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction
Treatment:
Device: Proprioception measurement on isokinetic dynamometer
Control
Placebo Comparator group
Description:
Control Group: 15 healthy volunteers, athletes.
Treatment:
Device: Proprioception measurement on isokinetic dynamometer

Trial contacts and locations

1

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Central trial contact

Joffrey DRIGNY, MD MSc

Data sourced from clinicaltrials.gov

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