Anterior Cruciate Ligament InjuriesNCT04137003
Laval University Rouge et or Post ACL Surgery Program Effectiveness
A study testing Rouge et Or Program and CHU intervention guide in people with Anterior Cruciate Ligament Injuries and ACL, run by Laval University at 1 site in Canada.
Trial summary
The main objective is to compare the effectiveness of two readaptation programs post anterior cruciate ligament surgery. Laval University Rouge et or program is to be compared with the intervention guide from the CHU. Amateur athletes are recruited 3 months post ACL surgery. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, ACL
- What is being tested?
- Rouge et Or Program and CHU intervention guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2019to 1 Sep 2020
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Amateur athlete aged from 18 to 35 years old doing sports at least 3 times a week
- Having suffered from an Anterior Cruciate Ligament rupture
- Having undergone Anterior Cruciate Ligament surgery either with an anterior approach (with the patellar tendon) or a posterior approach (with the semitendinosus tendon)
- Having a functional deficit (score 85% or under at Knee Outcome Survey - Activity of Daily Living Scale questionnaire and/or score 80% or under at International Knee Documentation Committee questionnaire)
- Being available for follow up and actively follow the programme attributed.
Who cannot join
- Having suffered from multiple surgery for other ligaments in the same knee.
- Having undergone total meniscus removal
- Having suffered form Posterior Cruciate Ligament rupture.
- Having other injuries that could affect the functional performance and prevent from training.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Université Laval
Québec, G1V 0A6
Maxime Provencher, 418-656-5501, mprovencher@live.ca
About this study
Official title: Laval University Rouge et Or Post Anterior Cruciate Ligament Surgery Readaptation Program Effectiveness With Amateur Athletes: A Randomised Clinical Trial
The main objective is to compare the effectiveness of two readaptation programs post anterior cruciate ligament surgery. Laval University Rouge et or program is to be compared with the intervention guide from the CHU. Amateur athletes are recruited 3 months post ACL surgery. The level of confidence, symptoms, functional recovery level and muscle strength are assessed and compared between the two groups at 3, 4, 5, 6 and 9-month post surgery.
Read the detailed description
It is experimental research with pre-post repeated measure with a control group. The subjects are randomised either in the intervention group (Gr PRORO-UL) or the control group (Gr CHU-CP). The assessor is blinded to the randomisation. Both groups receive their program at the first assessment at three months post-ACL-surgery. They are strongly encouraged to continue their follow-up in physiotherapy to ensure the program is suitable to their individual progression. The participants are assessed again at 4, 5, 6 and 9 months post surgery to measure their progression. A weekly journal sent by e-mail is to be filled to ensure the subjects train according to their program attribution. It is a randomised control trial with a blinded assessor.
- Conditions
- Anterior Cruciate Ligament Injuries, ACL
- Being tested
- Rouge et Or Program, CHU intervention guide
- Keywords
- Acl, Anterior cruciate ligament, Post surgery
- 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.
Rouge et Or ProgramOther
Also called (Gr PRORO-UL), Programme du rouge et Or, Laval University Rouge et Or program
It is a detailed, structured and precise training program. It is used from the third-month post ACL surgery to the sixth month.
CHU intervention guideOther
Also called Programme du CHU, (Gr CHU-CP), CHU program
From the third month to the sixth month, it outlines the progression to have in the training without precise information on exercises, parameter or frequency.
| Study group | Role | What they receive |
|---|---|---|
| Rouge et Or program | Experimental | Rouge et Or program group follow a detailed program that they do on their own. It is made of three cycles of four weeks each. Every cycle contains 3 training sessions by week with a minimum of 24 hours between sessions. The training volume is modulated for every cycle and every week. Each training sessions is made of 6 warm-up exercises followed by 6 training exercises. The exercises are a mix of strengthening, endurance, plyometric, neuromuscular control and dynamic stability. The exercises change every month with a progressively increasing difficulty towards the end to mimic return to sport demands. Receives: Other: Rouge et Or Program |
| CHU intervention guide | Active comparator | CHU intervention guide group follow the standard CHU protocol. At three months post-surgery, the protocol suggests progressing the exercises without precisely suggesting exercise, parameter or frequency. Receives: Other: CHU intervention guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Outcome Survey-Activity of Daily Living Scale
Questionnaire ranging from 0 to 70 over 70 where 70 means no limitation in activity of daily living. There is 14 questions with each graded answer providing 0 to 5 points that are summed together and expressed in percentage. The higher is the score, the better is the outcome.
Measured: 3, 4, 5, 6 and 9 months post-surgery
Secondary outcomes (33)
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Measured: 3 months post surgery
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Measured: 4 months post-surgery
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Measured: 5 months post-surgery
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Measured: 6 months post-surgery
Numerical Pain Rating Scale
Four questions related to pain that are graded from 0 to 10. The lower is the score, the better is the outcome.
Measured: 9 months post-surgery
Change in Anterior Cruciate Ligament Return to Sport Index
12 questions related to return to sport confidence graded from 0 to 10. All scores are summed together and expressed in percentage.The higher the score the better is the outcome.
Measured: 3, 4, 5, 6 and 9 months post-surgery
Change in International knee documentation committee
International knee documentation committee is a 10 items questionnaire measuring knee functional limitation. All items are summed and the total score range from 18 to 105. From that score we subtract 18 and divide by 87 and bring the score back in percentage. The final score can range from 0 to 100% where a higher score represents a better outcome.
Measured: 3, 4, 5, 6 and 9 months post-surgery
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Measured: 3 months post-surgery
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Measured: 4 months post-surgery
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Measured: 5 months post-surgery
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Measured: 6 months post-surgery
Muscle strength
Isometric flexion and extension strength is measured with a handheld dynamometer.
Measured: 9 months post-surgery
Muscle strength
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
Measured: 6 months post-surgery.
Muscle strength
Concentric isokinetic flexion and extension strength is measured with Biodex at speed 60 degree/sec.
Measured: 9 months post-surgery.
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 3 months post-surgery
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 4 months post-surgery
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 5 months post-surgery
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 6 months post-surgery
Single leg hop test.
The single-leg hop test is performed barefoot. The subjects are asked to jump as far as possible on one leg and to land keeping their balance. Measurement is made from the starting line to the place where the heel lands. The subjects must start behind the line. They perform one practice and three trials. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 9 months post-surgery
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 3 months post-surgery
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 4 months post-surgery
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 5 months post-surgery
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 6 months post-surgery
Triple hop test.
The Triple hop test is performed barefoot. The subjects are asked to jump on one leg three times in a row in one direction and to land the third jump in balance as far as possible. Measurement is made from the starting line to the place where the heel lands the third jump. The subjects must start behind the line. They perform one practice and three trial. The best trial is kept. The healthy limb is tested first followed by the injured leg.
Measured: 9 months post-surgery
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Measured: 3 months post-surgery
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Measured: 4 months post-surgery
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Measured: 5 months post-surgery
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Measured: 6 months post-surgery
30 seconds side hop test
The 30 seconds side hop test is performed barefoot. The subjects are asked to jump side to side on one leg as many time as possible during 30 seconds over a 40 cm distance separated by two lines. Each time the foot of the subjet touch one line, the repetition is not recorded. The number of jumps is recorded. They perform two practice jumps and one 30 secondes trial. The healthy limb is tested first followed by the injured leg.
Measured: 9 months post-surgery
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Measured: 4 months post-surgery
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Measured: 5 post-surgery
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Measured: 6 post-surgery
Global Rating Of Change
A 15 item scale to grade the change from the initial data collection.
Measured: 9 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start6 Mar 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc J. Hébert, PHD, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137003
- Sponsor's protocol ID
- ACL readaptation LavalU
- Status last verified
- Oct 2019
- First submitted
- 3 Jul 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laval University Rouge et Or Post Anterior Cruciate Ligament Surgery Readaptation Program Effectiveness With Amateur Athletes: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT04137003
- Acronym / sponsor ID
- ACL readaptation LavalU
- Conditions
- Anterior Cruciate Ligament Injuries, ACL
- Keywords
- Acl, Anterior cruciate ligament, Post surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 23 Oct 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.
The main objective is to compare the effectiveness of two readaptation programs post anterior cruciate ligament surgery. Laval University Rouge et or program is to be compared with the intervention guide from the CHU. Amateur athletes are recruited 3 months post ACL surgery. The level of confidence, symptoms, functional recovery level and muscle strength are assessed and compared between the two groups at 3, 4, 5, 6 and 9-month post surgery.
Detailed description
It is experimental research with pre-post repeated measure with a control group. The subjects are randomised either in the intervention group (Gr PRORO-UL) or the control group (Gr CHU-CP). The assessor is blinded to the randomisation. Both groups receive their program at the first assessment at three months post-ACL-surgery. They are strongly encouraged to continue their follow-up in physiotherapy to ensure the program is suitable to their individual progression. The participants are assessed again at 4, 5, 6 and 9 months post surgery to measure their progression. A weekly journal sent by e-mail is to be filled to ensure the subjects train according to their program attribution. It is a randomised control trial with a blinded assessor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental research with pre-post repeated measures with a control group. It is a randomised control trial with a blinded assessor
| Arm | Type | Receives |
|---|---|---|
| Rouge et Or program | Experimental | Other: Rouge et Or ProgramRouge et Or program group follow a detailed program that they do on their own. It is made of three cycles of four weeks each. Every cycle contains 3 training sessions by week with a minimum of 24 hours between sessions. The training volume is modulated for every cycle and every week. Each training sessions is made of 6 warm-up exercises followed by 6 training exercises. The exercises are a mix of strengthening, endurance, plyometric, neuromuscular control and dynamic stability. The exercises change every month with a progressively increasing difficulty towards the end to mimic return to sport demands. |
| CHU intervention guide | Active comparator | Other: CHU intervention guideCHU intervention guide group follow the standard CHU protocol. At three months post-surgery, the protocol suggests progressing the exercises without precisely suggesting exercise, parameter or frequency. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Amateur athlete aged from 18 to 35 years old doing sports at least 3 times a week
- Having suffered from an Anterior Cruciate Ligament rupture
- Having undergone Anterior Cruciate Ligament surgery either with an anterior approach (with the patellar tendon) or a posterior approach (with the semitendinosus tendon)
- Having a functional deficit (score 85% or under at Knee Outcome Survey - Activity of Daily Living Scale questionnaire and/or score 80% or under at International Knee Documentation Committee questionnaire)
- Being available for follow up and actively follow the programme attributed.
Key exclusion criteria (4 listed)
- Having suffered from multiple surgery for other ligaments in the same knee.
- Having undergone total meniscus removal
- Having suffered form Posterior Cruciate Ligament rupture.
- Having other injuries that could affect the functional performance and prevent from training.
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 |
|---|---|---|
| Rouge et Or ProgramAlso: (Gr PRORO-UL), Programme du rouge et Or, Laval University Rouge et Or programIt is a detailed, structured and precise training program. It is used from the third-month post ACL surgery to the sixth month. | Other | Rouge et Or program |
| CHU intervention guideAlso: Programme du CHU, (Gr CHU-CP), CHU programFrom the third month to the sixth month, it outlines the progression to have in the training without precise information on exercises, parameter or frequency. | Other | CHU intervention guide |
Primary outcome
Change in Knee Outcome Survey-Activity of Daily Living Scale
Time frame: 3, 4, 5, 6 and 9 months post-surgery
Questionnaire ranging from 0 to 70 over 70 where 70 means no limitation in activity of daily living. There is 14 questions with each graded answer providing 0 to 5 points that are summed together and expressed in percentage. The higher is the score, the better is the outcome.
33 secondary outcomes
Numerical Pain Rating Scale
Time frame: 3 months post surgery
Numerical Pain Rating Scale
Time frame: 4 months post-surgery
Numerical Pain Rating Scale
Time frame: 5 months post-surgery
Numerical Pain Rating Scale
Time frame: 6 months post-surgery
Numerical Pain Rating Scale
Time frame: 9 months post-surgery
Change in Anterior Cruciate Ligament Return to Sport Index
Time frame: 3, 4, 5, 6 and 9 months post-surgery
Change in International knee documentation committee
Time frame: 3, 4, 5, 6 and 9 months post-surgery
Muscle strength
Time frame: 3 months post-surgery
Muscle strength
Time frame: 4 months post-surgery
Muscle strength
Time frame: 5 months post-surgery
Muscle strength
Time frame: 6 months post-surgery
Muscle strength
Time frame: 9 months post-surgery
Muscle strength
Time frame: 6 months post-surgery.
Muscle strength
Time frame: 9 months post-surgery.
Single leg hop test.
Time frame: 3 months post-surgery
Single leg hop test.
Time frame: 4 months post-surgery
Single leg hop test.
Time frame: 5 months post-surgery
Single leg hop test.
Time frame: 6 months post-surgery
Single leg hop test.
Time frame: 9 months post-surgery
Triple hop test.
Time frame: 3 months post-surgery
Triple hop test.
Time frame: 4 months post-surgery
Triple hop test.
Time frame: 5 months post-surgery
Triple hop test.
Time frame: 6 months post-surgery
Triple hop test.
Time frame: 9 months post-surgery
30 seconds side hop test
Time frame: 3 months post-surgery
30 seconds side hop test
Time frame: 4 months post-surgery
30 seconds side hop test
Time frame: 5 months post-surgery
30 seconds side hop test
Time frame: 6 months post-surgery
30 seconds side hop test
Time frame: 9 months post-surgery
Global Rating Of Change
Time frame: 4 months post-surgery
Global Rating Of Change
Time frame: 5 post-surgery
Global Rating Of Change
Time frame: 6 post-surgery
Global Rating Of Change
Time frame: 9 post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
Luc J. Hébert, PHD study director
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rouge et Or Program and CHU intervention guide in people with Anterior Cruciate Ligament Injuries and ACL, run by Laval University at 1 site in Canada.
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 4 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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 Luc J. Hébert, PHD (418-529-9141 ext. 6579, lucj.hebert@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Outcome Survey-Activity of Daily Living Scale (time frame: 3, 4, 5, 6 and 9 months post-surgery). 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 28 Oct 2019; AzTrials last refreshed its copy on 31 Oct 2026.