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

ACL Tear Clinical Trial

— PRO-ACL  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058574
• Other study ID #: PRO-ACL
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2020
• Source: University Hospital, Caen
• Contact: Joffrey DRIGNY, MD MSc
• Phone: +332 31 06 45 33
• Email: drigny-j[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: January 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• ACL - Anterior Cruciate Ligament Deficiency
• ACL Tear
• Anterior Cruciate Ligament Injuries

Intervention

Device:
• Proprioception measurement on isokinetic dynamometer
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	Caen University Hospital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline passive proprioceptive evaluation after 7 months	Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.	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
Primary	Change from Baseline active proprioceptive evaluation after 7 months	Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.	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
Primary	Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 months	Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.	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	Strength	Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.	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
Secondary	ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)	The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each	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
Secondary	Functional testing	Hop test. Single hop: Patients are instructed to stand on one leg and perform 1 jump as far as possible, landing on the same leg.; The total distance is recorded (in cm) .Triple hop: Patients are instructed to stand on one leg and perform 3 hops as far as possible, landing on the same leg.; The total distance for 3 consecutive hops is recorded (in cm). Cross-over hop test : The patient hops forward 3 times while alternately crossing over a marking The patient is instructed to position themselves such that the first of the 3 hops was lateral with respect to the direction of crossover The total distance hopped forward is recorded (in cm)	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