Clinical trial NCT04058574: Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ACL Tear
ACL - Anterior Cruciate Ligament Deficiency
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-08-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction Control Group: 15 healthy volunteers, athletes.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from Baseline passive proprioceptive evaluation after 7 months
timeFrame: 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
measure: Change from Baseline active proprioceptive evaluation after 7 months
timeFrame: 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
measure: Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 months
timeFrame: 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
Secondary outcomes:
measure: Strength
timeFrame: 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
measure: ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
timeFrame: 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
measure: Functional testing
timeFrame: 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
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References: