ACL TearPRO-ACLNCT04058574
Proprioceptive Isokinetic Repositioning, Functional Testing, and a Self-reported Questionnaire Before and After Anterior Cruciate Ligament Reconstruction
A study testing Proprioception measurement on isokinetic dynamometer in people with ACL Tear and ACL - Anterior Cruciate Ligament Deficiency, run by University Hospital, Caen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Tear, ACL - Anterior Cruciate Ligament Deficiency
- What is being tested?
- Proprioception measurement on isokinetic dynamometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2019to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnant woman
- Neurological or vestibular antecedent with sequelae
- Individuals taking treatment altering alertness (neuroleptics, sedatives)
- Informed consent not obtained
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Caen University Hospital
Caen
Joffrey DRIGNY, MD MSc
- Recruiting
Caen University Hospital
Caen
Joffrey Drigny, MD MSc, +33231064533, drigny-j@chu-caen.fr
About this study
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.
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.
Read the 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.
- Being tested
- Proprioception measurement on isokinetic dynamometer
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception measurement on isokinetic dynamometerDevice
Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)
| Study group | Role | What they receive |
|---|---|---|
| ACL | Active comparator | Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction Receives: Device: Proprioception measurement on isokinetic dynamometer |
| Control | Placebo comparator | Control Group: 15 healthy volunteers, athletes. Receives: Device: Proprioception measurement on isokinetic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline passive proprioceptive evaluation after 7 months
Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Measured: 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
Change from Baseline active proprioceptive evaluation after 7 months
Measurement of knee proprioception by the active repositioning technique (JPS, in degrees) on isokinetic dynamometer.
Measured: 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
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.
Measured: 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 (3)
Strength
Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.
Measured: 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)
The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each
Measured: 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
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joffrey DRIGNY, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058574
- Sponsor's protocol ID
- PRO-ACL
- Acronym
- PRO-ACL
- Status last verified
- Jul 2020
- First submitted
- 9 Aug 2019
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04058574
- Acronym / sponsor ID
- PRO-ACL / PRO-ACL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction Control Group: 15 healthy volunteers, athletes.
| Arm | Type | Receives |
|---|---|---|
| ACL | Active comparator | Device: Proprioception measurement on isokinetic dynamometerIntervention Group "ACL": 30 patient, athletes, with ACL deficiency candidate to a surgical ACL reconstruction |
| Control | Placebo comparator | Device: Proprioception measurement on isokinetic dynamometerControl Group: 15 healthy volunteers, athletes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioception measurement on isokinetic dynamometerProprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM) | Device | ACL, Control |
Primary outcome
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.
3 secondary outcomes
Strength
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
ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)
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
Functional testing
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioception measurement on isokinetic dynamometer in people with ACL Tear and ACL - Anterior Cruciate Ligament Deficiency, run by University Hospital, Caen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joffrey DRIGNY, MD MSc (+332 31 06 45 33, drigny-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.