Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction (PRO-ACL)
Primary Purpose
ACL Tear, ACL - Anterior Cruciate Ligament Deficiency
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Proprioception measurement on isokinetic dynamometer
Sponsored by
About this trial
This is an interventional prevention trial for ACL Tear
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
Sites / Locations
- Caen University HospitalRecruiting
- Caen University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACL
Control
Arm Description
Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction
Control Group: 15 healthy volunteers, athletes.
Outcomes
Primary Outcome Measures
Change from Baseline passive proprioceptive evaluation after 7 months
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Change from Baseline active proprioceptive evaluation after 7 months
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
Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.
Secondary Outcome Measures
Strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
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
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)
Full Information
NCT ID
NCT04058574
First Posted
August 9, 2019
Last Updated
July 13, 2020
Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT04058574
Brief Title
Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Caen
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Tear, ACL - Anterior Cruciate Ligament Deficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction Control Group: 15 healthy volunteers, athletes.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACL
Arm Type
Active Comparator
Arm Description
Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control Group: 15 healthy volunteers, athletes.
Intervention Type
Device
Intervention Name(s)
Proprioception measurement on isokinetic dynamometer
Intervention Description
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)
Primary Outcome Measure Information:
Title
Change from Baseline passive proprioceptive evaluation after 7 months
Description
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
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
Title
Change from Baseline active proprioceptive evaluation after 7 months
Description
Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.
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
Title
Change from Baseline TDPM (Threshold to Detection of Passive Motion) evaluation after 7 months
Description
Measurement of knee proprioception by the Threshold to Detection of Passive Motion (TDPM in degrees) on isokinetic dynamometer.
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
Secondary Outcome Measure Information:
Title
Strength
Description
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Time Frame
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
Title
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
Description
The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Time Frame
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
Title
Functional testing
Description
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)
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joffrey DRIGNY, MD MSc
Phone
+332 31 06 45 33
Email
drigny-j@chu-caen.fr
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joffrey DRIGNY, MD MSc
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joffrey Drigny, MD MSc
Phone
+33231064533
Email
drigny-j@chu-caen.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction
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