Anterior Cruciate Ligament ReconstructionNCT05152758
STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction
A study testing PARx in people with Anterior Cruciate Ligament Reconstruction and Post-traumatic Osteoarthritis, run by Western University, Canada at 1 site in Canada.
Trial summary
Anterior cruciate ligament (ACL) ruptures are very common knee injuries amongst youth involved in sports and are often treated through ACL reconstruction surgeries. Unfortunately, up to 50% of individuals who undergo ACL reconstruction develop post-traumatic osteoarthritis (PTOA) in their injured knee by 20 years… Read more about this study
- Who is it for?
- Ages 21 to 32 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction, Post-traumatic Osteoarthritis
- What is being tested?
- PARx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 32 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects following up for 7-year visits as part of the Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study (STAbiLiTY)
Who cannot join
- Unable/unwilling to follow up for the study period
- Does not have access to the internet and/or smartphone
- Cannot communicate in English
- Unstable medical conditions that would preclude engagement in prescribed physical activity
- Scheduled for second surgery over study period
Trial locations and contacts
1 site in 1 country.
About this study
Anterior cruciate ligament (ACL) ruptures are very common knee injuries amongst youth involved in sports and are often treated through ACL reconstruction surgeries. Unfortunately, up to 50% of individuals who undergo ACL reconstruction develop post-traumatic osteoarthritis (PTOA) in their injured knee by 20 years post-reconstruction causing pain, decreasing mobility, and impacting quality of life in young active individuals. Much remains unknown regarding the secondary prevention of PTOA, and more investigation is necessary to better understand its disease progression post-ACL reconstruction and types of conservative interventions that can prevent or delay its onset.
Physical activity has improved patient-reported outcomes across many different chronic diseases including knee osteoarthritis (OA), and physical activity prescription has been shown to be an effective way to increase patients' levels of physical activity. It has not yet been heavily investigated in the context of post-ACL reconstruction, and individuals often exhibit decreased physical activity after ACL reconstruction which causes suboptimal cartilage health. Thus, physical activity prescription may improve habitual joint loading, leading to improved cartilage health and patient-reported health outcomes.
Read the detailed description
ACL injuries are extremely common knee injuries sustained by athletes participating in sports involving sudden changes of direction like jumping, cutting and pivoting. Every year, approximately 1 in 3500 individuals injure their ACL. ACL reconstruction surgery is a popular treatment option for young athletes that aims to re-establish knee stability and restore function, enabling high rates of return to sport. Unfortunately, despite reconstruction surgery's short-term benefits, it does not significantly alter the course of post-traumatic osteoarthritis (PTOA) that often develops after sustaining a severe knee injury. In fact, over half of ACL patients present radiographic signs of OA by 20 years post-reconstruction surgery. Individuals with OA often have significantly impaired mobility, functionality, and quality of life, so appropriate rehabilitation protocols and conservative joint management strategies are necessary to improve knee health outcomes post-reconstruction and keep these patients healthy and active for as long as possible.
Physical activity has widely known preventive and therapeutic effects across many chronic diseases such as diabetes, hypertension, heart disease, and obesity. Similarly, there is widespread evidence of high physical activity levels reducing pain and increasing function and health-related quality of life in individuals with knee and hip osteoarthritis, indicating its efficacy as a conservative measure for improving joint health. In contrast, sedentary behaviour increases the risk of OA development and other comorbidities by increasing body mass index (BMI), causing poorer cartilage health, reducing muscle quality, and increasing systemic inflammation. Following ACL reconstruction, individuals are susceptible to adopting more sedentary lifestyles due to a fear of re-injury through movement, evidenced by relatively lower self-reported physical activity levels compared to before injury. While ACL injuries may initiate OA pathogenesis, sedentary behaviour is a modifiable risk factor that can further facilitate disease progression. Since physical activity prescription effectively increases physical activity levels, it offers potential utility for improving knee joint health post-reconstruction surgery and preventing or delaying the onset of PTOA.
Objectives:
- To examine the effects of physical activity prescription on patient-reported outcomes (KOOS and IKDC scores)
- To examine the effects of physical activity prescription on femoral trochlear cartilage thickness and echo intensity based on ultrasound imaging over 1 year.
- To analyze the impact of patients' gait biomechanics on changes in patient-reported outcomes and femoral trochlear cartilage health outcomes due to the physical activity intervention.
Hypotheses:
- Those assigned to the physical activity prescription group will have higher KOOS and IKDC scores than those in the control group following 1 year.
- Physical activity prescription will lead to less reductions in echo intensity and heterogeneity of the femoral trochlear cartilage over 1 year.
- Poorer femoral trochlear cartilage health imaging outcomes (greater reductions in echo intensity and heterogeneity) and lower KOOS and IKDC scores at 1 year will be associated with larger vertical ground reaction forces, smaller knee flexion angles, greater knee adduction moments, smaller knee extensor moments, and larger vertical loading rates of the involved limb.
- Being tested
- PARx
- Keywords
- physical activity, anterior cruciate ligament reconstruction, osteoarthritis
- Medical subject headings
- Motor Activity, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARxDevice
Prescription Physical Activity Programming Application
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will receive the usual care. |
| Physical Activity Prescription (PARx) | Experimental | Patients will be prescribed technology-based physical activity programming. Receives: Device: PARx |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee (IKDC)
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
Measured: Baseline
International Knee Documentation Committee (IKDC)
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
Measured: 2 months
International Knee Documentation Committee (IKDC)
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
Measured: 6 months
International Knee Documentation Committee (IKDC)
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
Measured: 12 months
Secondary outcomes (11)
Knee Injury and Osteoarthritis Outcome Score
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: Baseline
Knee Injury and Osteoarthritis Outcome Score
Knee-specific survey that evaluates short-term and long-term consequences of knee injury with 42 questions across 5 subscales: pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life. Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 2 months
Knee Injury and Osteoarthritis Outcome Score
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 6 months
Knee Injury and Osteoarthritis Outcome Score
Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. The KOOS is a patient reported joint-specific score, which may be useful for assessing changes in knee pathology over time, with or without treatment.
Measured: 12 months
Ultrasonographic Femoral Trochlear Cartilage Imaging
Ultrasonographic imaging of the femoral trochlear cartilage will help visualize and compare deleterious cartilage changes between the PA intervention group and the usual care group. A Logiq e ultrasound machine (GE Healthcare) will be used to measure cartilage thickness, echo-intensity, and heterogeneity to assess composition quality.
Measured: Baseline
Ultrasonographic Femoral Trochlear Cartilage Imaging
Ultrasonographic imaging of the femoral trochlear cartilage will help visualize and compare deleterious cartilage changes between the PA intervention group and the usual care group. A Logiq e ultrasound machine (GE Healthcare) will be used to measure cartilage thickness, echo-intensity, and heterogeneity to assess composition quality.
Measured: 12 months
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
The GPAQ is a 22-item questionnaire designed to estimate patients' physical activity levels in work, transport, and leisure time as well as time spent doing sedentary behaviours. It also asks two questions to determine the patient's level of positive attitude towards physical activity and the barriers that may prevent them from physical activity engagement. MyRecovery is a smartphone app that tracks steps per day, light/moderate/vigorous activity, and total MET-min through accelerometer data.
Measured: Baseline
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
The GPAQ is a 22-item questionnaire designed to estimate patients' physical activity levels in work, transport, and leisure time as well as time spent doing sedentary behaviours. It also asks two questions to determine the patient's level of positive attitude towards physical activity and the barriers that may prevent them from physical activity engagement. MyRecovery is a smartphone app that tracks steps per day, light/moderate/vigorous activity, and total metabolic equivalents through accelerometer data.
Measured: 2 months
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
The GPAQ is a 22-item questionnaire designed to estimate patients' physical activity levels in work, transport, and leisure time as well as time spent doing sedentary behaviours. It also asks two questions to determine the patient's level of positive attitude towards physical activity and the barriers that may prevent them from physical activity engagement. MyRecovery is a smartphone app that tracks steps per day, light/moderate/vigorous activity, and total metabolic equivalents through accelerometer data.
Measured: 6 months
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
The GPAQ is a 22-item questionnaire designed to estimate patients' physical activity levels in work, transport, and leisure time as well as time spent doing sedentary behaviours. It also asks two questions to determine the patient's level of positive attitude towards physical activity and the barriers that may prevent them from physical activity engagement. MyRecovery is a smartphone app that tracks steps per day, light/moderate/vigorous activity, and total MET-min through accelerometer data.
Measured: 12 months
Three-dimensional Motion-captured Gait Biomechanics Analysis
Walking gait biomechanics will be motion-captured and analyzed to identify individuals with asymmetries in lower-limb biomechanics during walking. Metrics used will include peak knee adduction moment, peak knee flexion moment, vertical ground reaction force, and vertical loading rate.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start1 Nov 2021
- Primary completion20 Dec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial will randomize up to 196 ACL-reconstruction patients to receive either the standard of care or a physical activity prescription (PARx) at 7 years post-reconstruction in a 1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Thornton, MD PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152758
- Sponsor's protocol ID
- STABILITY PARx Sub-Study
- Status last verified
- May 2025
- First submitted
- 4 Nov 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cinque ME, Dornan GJ, Chahla J, Moatshe G, LaPrade RF. High Rates of Osteoarthritis Develop After Anterior Cruciate Ligament Surgery: An Analysis of 4108 Patients. Am J Sports Med. 2018 Jul;46(8):2011-2019. doi: 10.1177/0363546517730072. Epub 2017 Oct 6.
PubMed 28982255Ravalli S, Castrogiovanni P, Musumeci G. Exercise as medicine to be prescribed in osteoarthritis. World J Orthop. 2019 Jul 18;10(7):262-267. doi: 10.5312/wjo.v10.i7.262. eCollection 2019 Jul 18.
PubMed 31363456Evans J, Nielson JL. Anterior Cruciate Ligament Knee Injuries. 2021 Feb 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. PMID: 29763023.
Kraus VB, Sprow K, Powell KE, Buchner D, Bloodgood B, Piercy K, George SM, Kraus WE; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Effects of Physical Activity in Knee and Hip Osteoarthritis: A Systematic Umbrella Review. Med Sci Sports Exerc. 2019 Jun;51(6):1324-1339. doi: 10.1249/MSS.0000000000001944.
PubMed 31095089Maly MR, Marriott KA, Chopp-Hurley JN. Osteoarthritis year in review 2019: rehabilitation and outcomes. Osteoarthritis Cartilage. 2020 Mar;28(3):249-266. doi: 10.1016/j.joca.2019.11.008. Epub 2019 Dec 23.
PubMed 31877379Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
PubMed 26606383
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STABILITY: Physical Activity Intervention at 7 Years Post-Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05152758
- Acronym / sponsor ID
- STABILITY PARx Sub-Study
- Keywords
- physical activity, anterior cruciate ligament reconstruction, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2021 (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.
Anterior cruciate ligament (ACL) ruptures are very common knee injuries amongst youth involved in sports and are often treated through ACL reconstruction surgeries. Unfortunately, up to 50% of individuals who undergo ACL reconstruction develop post-traumatic osteoarthritis (PTOA) in their injured knee by 20 years post-reconstruction causing pain, decreasing mobility, and impacting quality of life in young active individuals. Much remains unknown regarding the secondary prevention of PTOA, and more investigation is necessary to better understand its disease progression post-ACL reconstruction and types of conservative interventions that can prevent or delay its onset.
Physical activity has improved patient-reported outcomes across many different chronic diseases including knee osteoarthritis (OA), and physical activity prescription has been shown to be an effective way to increase patients' levels of physical activity. It has not yet been heavily investigated in the context of post-ACL reconstruction, and individuals often exhibit decreased physical activity after ACL reconstruction which causes suboptimal cartilage health. Thus, physical activity prescription may improve habitual joint loading, leading to improved cartilage health and patient-reported health outcomes.
Detailed description
ACL injuries are extremely common knee injuries sustained by athletes participating in sports involving sudden changes of direction like jumping, cutting and pivoting. Every year, approximately 1 in 3500 individuals injure their ACL. ACL reconstruction surgery is a popular treatment option for young athletes that aims to re-establish knee stability and restore function, enabling high rates of return to sport. Unfortunately, despite reconstruction surgery's short-term benefits, it does not significantly alter the course of post-traumatic osteoarthritis (PTOA) that often develops after sustaining a severe knee injury. In fact, over half of ACL patients present radiographic signs of OA by 20 years post-reconstruction surgery. Individuals with OA often have significantly impaired mobility, functionality, and quality of life, so appropriate rehabilitation protocols and conservative joint management strategies are necessary to improve knee health outcomes post-reconstruction and keep these patients healthy and active for as long as possible.
Physical activity has widely known preventive and therapeutic effects across many chronic diseases such as diabetes, hypertension, heart disease, and obesity. Similarly, there is widespread evidence of high physical activity levels reducing pain and increasing function and health-related quality of life in individuals with knee and hip osteoarthritis, indicating its efficacy as a conservative measure for improving joint health. In contrast, sedentary behaviour increases the risk of OA development and other comorbidities by increasing body mass index (BMI), causing poorer cartilage health, reducing muscle quality, and increasing systemic inflammation. Following ACL reconstruction, individuals are susceptible to adopting more sedentary lifestyles due to a fear of re-injury through movement, evidenced by relatively lower self-reported physical activity levels compared to before injury. While ACL injuries may initiate OA pathogenesis, sedentary behaviour is a modifiable risk factor that can further facilitate disease progression. Since physical activity prescription effectively increases physical activity levels, it offers potential utility for improving knee joint health post-reconstruction surgery and preventing or delaying the onset of PTOA.
Objectives:
- To examine the effects of physical activity prescription on patient-reported outcomes (KOOS and IKDC scores)
- To examine the effects of physical activity prescription on femoral trochlear cartilage thickness and echo intensity based on ultrasound imaging over 1 year.
- To analyze the impact of patients' gait biomechanics on changes in patient-reported outcomes and femoral trochlear cartilage health outcomes due to the physical activity intervention.
Hypotheses:
- Those assigned to the physical activity prescription group will have higher KOOS and IKDC scores than those in the control group following 1 year.
- Physical activity prescription will lead to less reductions in echo intensity and heterogeneity of the femoral trochlear cartilage over 1 year.
- Poorer femoral trochlear cartilage health imaging outcomes (greater reductions in echo intensity and heterogeneity) and lower KOOS and IKDC scores at 1 year will be associated with larger vertical ground reaction forces, smaller knee flexion angles, greater knee adduction moments, smaller knee extensor moments, and larger vertical loading rates of the involved limb.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This trial will randomize up to 196 ACL-reconstruction patients to receive either the standard of care or a physical activity prescription (PARx) at 7 years post-reconstruction in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive the usual care. |
| Physical Activity Prescription (PARx) | Experimental | Device: PARxPatients will be prescribed technology-based physical activity programming. |
Who may qualify
- Ages
- 21 to 32 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects following up for 7-year visits as part of the Standard ACL Reconstruction vs ACL + Lateral Extra-Articular Tenodesis Study (STAbiLiTY)
Key exclusion criteria (5 listed)
- Unable/unwilling to follow up for the study period
- Does not have access to the internet and/or smartphone
- Cannot communicate in English
- Unstable medical conditions that would preclude engagement in prescribed physical activity
- Scheduled for second surgery over study period
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 |
|---|---|---|
| PARxPrescription Physical Activity Programming Application | Device | Physical Activity Prescription (PARx) |
Primary outcome
International Knee Documentation Committee (IKDC)
Time frame: Baseline
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
International Knee Documentation Committee (IKDC)
Time frame: 2 months
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
International Knee Documentation Committee (IKDC)
Time frame: 6 months
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
International Knee Documentation Committee (IKDC)
Time frame: 12 months
This form uses a subjective scale to provide a score from 0 to 100 indicating the patient's overall level of function. The total score is determined by adding individual scores from three categories: symptoms, sports activity, and knee function.
11 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline
Knee Injury and Osteoarthritis Outcome Score
Time frame: 2 months
Knee Injury and Osteoarthritis Outcome Score
Time frame: 6 months
Knee Injury and Osteoarthritis Outcome Score
Time frame: 12 months
Ultrasonographic Femoral Trochlear Cartilage Imaging
Time frame: Baseline
Ultrasonographic Femoral Trochlear Cartilage Imaging
Time frame: 12 months
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
Time frame: Baseline
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
Time frame: 2 months
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
Time frame: 6 months
Physical Activity Evaluation using Global Physical Activity Questionnaire (GPAQ) and MyRecovery app
Time frame: 12 months
Three-dimensional Motion-captured Gait Biomechanics Analysis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 28982255Cinque ME, Dornan GJ, Chahla J, Moatshe G, LaPrade RF. High Rates of Osteoarthritis Develop After Anterior Cruciate Ligament Surgery: An Analysis of 4108 Patients. Am J Sports Med. 2018 Jul;46(8):2011-2019. doi: 10.1177/0363546517730072. Epub 2017 Oct 6.
- Background: PubMed 31363456Ravalli S, Castrogiovanni P, Musumeci G. Exercise as medicine to be prescribed in osteoarthritis. World J Orthop. 2019 Jul 18;10(7):262-267. doi: 10.5312/wjo.v10.i7.262. eCollection 2019 Jul 18.
- BackgroundEvans J, Nielson JL. Anterior Cruciate Ligament Knee Injuries. 2021 Feb 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. PMID: 29763023.
- Background: PubMed 31095089Kraus VB, Sprow K, Powell KE, Buchner D, Bloodgood B, Piercy K, George SM, Kraus WE; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Effects of Physical Activity in Knee and Hip Osteoarthritis: A Systematic Umbrella Review. Med Sci Sports Exerc. 2019 Jun;51(6):1324-1339. doi: 10.1249/MSS.0000000000001944.
- Background: PubMed 31877379Maly MR, Marriott KA, Chopp-Hurley JN. Osteoarthritis year in review 2019: rehabilitation and outcomes. Osteoarthritis Cartilage. 2020 Mar;28(3):249-266. doi: 10.1016/j.joca.2019.11.008. Epub 2019 Dec 23.
- Background: PubMed 26606383Pedersen BK, Saltin B. Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Scand J Med Sci Sports. 2015 Dec;25 Suppl 3:1-72. doi: 10.1111/sms.12581.
- Individual participant dataSharing planned: No
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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.
Jane Thornton, MD PhD principal investigator
Western 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 PARx in people with Anterior Cruciate Ligament Reconstruction and Post-traumatic Osteoarthritis, run by Western University, Canada 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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee (IKDC) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152758, which also lists 6 linked publications.
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 13 May 2025.