Knee OsteoarthritisEXTRANCT03215602
EXercise as TReatment for osteoArthritis
A study testing NEMEX and education + strength training and NEMEX and education in people with Knee Osteoarthritis, run by Slagelse Hospital at 1 site in Denmark.
Trial summary
Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of pain and disability worldwide. Exercise has previously demonstrated good effect in alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- NEMEX and education + strength training and NEMEX and education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jul 2017to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic and radiographically confirmed knee-OA who are found not eligible for knee replacement surgery by an orthopaedic surgeon in secondary health care.
Who cannot join
- Kellgren \& Lawrence score of <2 on radiography
- Less than "mild" symptoms (mean score >75 in 0-100 KOOS-ADL)
- Medication: Morphine for pain other than knee-joint pain
- Previous ipsilateral knee arthroplasty
- Rheumatoid arthritis
- Inability to comply with the protocol
- Inadequacy in written and spoken Danish
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of planned Orthopaedic Surgery, Naestved Hospital
Næstved, Region Sjælland, 4700
About this study
Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of pain and disability worldwide. Exercise has previously demonstrated good effect in alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown.
This study seeks to evaluate the effects of supplementary focused, knee extensor strength training in addition to neuromuscular exercise (NEMEX) and education in people with OA of the knee as performed in Good Life with osteoArthritis in Denmark (GLA:D ᵀᴹ).
Read more
Through a randomized design, study participants will either be allocated to 12 weeks (twice weekly) of NEMEX and education or 12 weeks (twice weekly) of NEMEX and education and focused, knee extensor strength training.
The primary outcome measurement for this study is the Knee injury and Osteoarthritis Outcome Score, subscale Activities of Daily Living (KOOS-ADL), which is a self-reported questionnaire on daily life activities. Other outcomes include parameters of maximal muscle strength and muscle power, muscle imaging, physical function, pain and self-reported health status.
Read the detailed description
Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases worldwide. In Denmark, it is estimated that approximately 900.000 people, or 1 out of 5 residents are suffering from OA in one or more joints. The annual socio-economic costs (treatment and loss of labour) as a direct consequence of OA in Denmark are estimated to 11.5 billion "Danish kroner" (DKK).
Osteoarthritis of the knee is the most frequently reported and disabling OA subgroup and is mainly reported in middle-aged adults (≥40 years) with an increasing prevalence with increasing age. Knee osteoarthritis is associated with knee pain, loss of lower limb muscle strength, activity limitations and reduced quality of life. Moreover, pain sensitization, i.e. increased responsiveness of nociceptive neurons, is another mechanism involved in pain and disability in knee-OA and may contribute to the frequently reported disparities between pain symptoms and radiographic signs of structural damage.
The current non-surgical treatment recommendations in Denmark as well as internationally include offering one or more of: Patient education, dietary advice, weight loss counselling and exercise. Exercise has proven to be a potent stimulus to improve function, and general quality of life in people with knee-OA. Moreover, exercise has been shown to reduce pain sensitization in knee-OA subjects with clinical signs of sensitization. However, there is still a paucity of information on the exact exercise mode for greatest beneficial effects in the knee-OA population.
Reduced lower limb muscle strength has repeatedly been suggested as one of the main working mechanisms behind knee-OA symptoms and quadriceps muscle strength is even suggested as a potential mediating factor in future knee joint space narrowing and longitudinal worsening of knee-joint pain. A recent systematic review revealed upper leg muscle strength along with joint proprioception to be two of the most potent mediating factors in symptomatic knee-OA.
In a randomized controlled trial (RCT) design, this study seeks to investigate potential added benefits of supplementing NEMEX and education with focused knee extensor strength training in patients with knee-OA. 90 patients deemed ineligible for knee replacement surgery will be recruited from the ambulatory setting at Naestved Hospital. By random allocation, patients will be recruited to either 12 weeks (twice weekly) of NEMEX and education + focused knee extensor strength training (intervention group) or 12 weeks (twice weekly) of NEMEX and education only (control group).
The main outcome is the change in KOOS-ADL from baseline to 12-week follow-up. Other outcomes include the remaining KOOS subscales, self-reported pain, health status, physical activity and patient satisfaction, knee extensor muscle power and knee extensor maximal contractile strength, pain sensitization, MRI assessed thigh muscle quality and physical function.
- Conditions
- Knee Osteoarthritis
- Being tested
- NEMEX and education + strength training, NEMEX and education
- Keywords
- knee, osteoarthritis, exercise, quadriceps, strength, activities of daily living, treatment outcome
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMEX and education + strength trainingOther
Also called GLA:D + strength training
Optimizing sensorimotor control and achieving functional stability. Increasing knee extensor muscle strength. Teaching everyday disease management.
NEMEX and educationOther
Also called GLA:D
Optimizing sensorimotor control and achieving functional stability. Teaching everyday disease management.
| Study group | Role | What they receive |
|---|---|---|
| NEMEX and education + strength training | Experimental | Participants will undergo 12 weeks of twice weekly exercise. Each exercise session will last for 70-90 min. and will consist of 1 hour of specific exercises to optimize sensorimotor control and achieve compensatory functional stability performed in a multiple-joint weight-bearing specific manner. The final part of the session will consist of focused knee extensor strength training performed in gym machines (knee extension \& leg-press) in a combination of low-load fatiguing exercises (knee-extension) followed by high-load exercises (leg-press).
Additionally, participants will receive 2 educational sessions, which include disease- and exercise specific counseling. Receives: Other: NEMEX and education + strength training |
| NEMEX and education | Active comparator | Participants will undergo 12 weeks of twice weekly exercise. Each exercise session will last for approximately 60 min. and will consist of 1 hour of specific exercises to optimize sensorimotor control and achieve compensatory functional stability performed in a multiple-joint weight-bearing specific manner.
Additionally, participants will receive 2 educational sessions, which include disease- and exercise specific counseling. Receives: Other: NEMEX and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
KOOS is a validated and extensively used self-reported outcome measure for people with knee OA. KOOS consists of five subscales, of which the subscale KOOS-ADL will be the primary outcome for this study. KOOS-ADL consists of 17 questions, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). KOOS-ADL has demonstrated a test-retest reliability (ICC) of 0.84-0.94 as well as demonstrating responsiveness to change following physical therapy in knee osteoarthritis.
Measured: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.
Secondary outcomes (5)
Muscle power (watt/kg. bodyweight)
Knee extensor muscle power (force times acceleration) will be measured using the Nottingham Power Rig (NPR). The NPR measures the power output in total watt and watt pr. bodyweight in kilograms from a seated push on a flat pedal which is transmitted by a lever and chain to spin a flywheel. The NPR is a safe and reliable method to measure explosive knee extensor muscle power and has been validated as a clinically important measure of muscle function in elderly individuals.
Measured: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: Baseline to 6 weeks.
Functional performance (40 m walk & stair-climbs)
Assessment of functional performance involves time (in seconds) taken to complete a 40 m course at fast walking pace as well as time taken to negotiate 9 steps on a standard step-height stair-way. The tests are part of the recommended functional performance tests in knee osteoarthritis.
Measured: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: 6 weeks.
Pain medication
Assessment of pain medication intake specific for knee pain. Derived as part of self-reported outcome measure.
Measured: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.
KOOS (remaining four subscales)
The four remaining subscales of the validated KOOS questionnaire (see primary outcome for further info on KOOS). The 4 remaining subscales cover: symptoms, pain, sport \& recreation and quality of life.
Measured: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.
AE (adverse events) & Serious Adverse Events (SAE)
Continous registration of health issues and injuries. Physiotherapists in charge of the training sessions will monitor potential AE and SAE. Also, during the follow-up visits at week 6 and week 12, the participants will be asked about potential AE's and SAE's using open-probe questions. Finally, the 12 month follow-up will include questions regarding AE's and SAE's during the preceding period from baseline to 12 months.
Measured: Primary endpoint: From baseline to 12 weeks.. Secondary endpoint: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start18 Jul 2017
- Primary completion8 Mar 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Parallel group, assessor- and patient blinded randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Rheumatism Association, Region Zealand, Naestved Hospital, University of Southern Denmark
- Responsible party
- Principal investigator, Pætur Mikal Holm, Slagelse Hospital
- Investigators
- Pætur M Holm, PT, MSc, Principal investigator, University of Southern Denmark and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospitals.Søren T Skou, PT, PhD, Study chair, University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.Henrik M Schøder, MD, Study chair, Naestved HospitalMathias Wernbom, PT, PhD, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215602
- Sponsor's protocol ID
- SJ-517
- Acronym
- EXTRA
- Status last verified
- Sep 2020
- First submitted
- 10 Jul 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pajaniaye JB, Cheret EP, Langvad CH, Holm PM, Skou ST, Larsen JB, Mechkenburg I. Knee osteoarthritis and minimal important change for the nine-step stair climb test. Dan Med J. 2026 Feb 5;73(3):A03250164. doi: 10.61409/A03250164.
PubMed 41772995Holm PM, Kemnitz J, Bandholm T, Wernbom M, Schroder HM, Skou ST. Muscle Function Tests as Supportive Outcome Measures for Performance-Based and Self-Reported Physical Function in Patients With Knee Osteoarthritis: Exploratory Analysis of Baseline Data From a Randomized Trial. J Strength Cond Res. 2022 Sep 1;36(9):2635-2642. doi: 10.1519/JSC.0000000000003840. Epub 2020 Oct 5.
PubMed 33021580Holm PM, Nyberg M, Wernbom M, Schroder HM, Skou ST. Intrarater Reliability and Agreement of Recommended Performance-Based Tests and Common Muscle Function Tests in Knee Osteoarthritis. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):144-152. doi: 10.1519/JPT.0000000000000266.
PubMed 32304510Holm PM, Schroder HM, Wernbom M, Skou ST. Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jun;28(6):744-754. doi: 10.1016/j.joca.2020.02.839. Epub 2020 Mar 13.
PubMed 32179197
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXercise as TReatment for osteoArthritis
- ClinicalTrials.gov ID
- NCT03215602
- Acronym / sponsor ID
- EXTRA / SJ-517
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, exercise, quadriceps, strength, activities of daily living, treatment outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- The Danish Rheumatism Association, Region Zealand, Naestved Hospital, University of Southern Denmark
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 12 Jul 2017 (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.
Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of pain and disability worldwide. Exercise has previously demonstrated good effect in alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown.
This study seeks to evaluate the effects of supplementary focused, knee extensor strength training in addition to neuromuscular exercise (NEMEX) and education in people with OA of the knee as performed in Good Life with osteoArthritis in Denmark (GLA:D ᵀᴹ).
Through a randomized design, study participants will either be allocated to 12 weeks (twice weekly) of NEMEX and education or 12 weeks (twice weekly) of NEMEX and education and focused, knee extensor strength training.
The primary outcome measurement for this study is the Knee injury and Osteoarthritis Outcome Score, subscale Activities of Daily Living (KOOS-ADL), which is a self-reported questionnaire on daily life activities. Other outcomes include parameters of maximal muscle strength and muscle power, muscle imaging, physical function, pain and self-reported health status.
Detailed description
Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases worldwide. In Denmark, it is estimated that approximately 900.000 people, or 1 out of 5 residents are suffering from OA in one or more joints. The annual socio-economic costs (treatment and loss of labour) as a direct consequence of OA in Denmark are estimated to 11.5 billion "Danish kroner" (DKK).
Osteoarthritis of the knee is the most frequently reported and disabling OA subgroup and is mainly reported in middle-aged adults (≥40 years) with an increasing prevalence with increasing age. Knee osteoarthritis is associated with knee pain, loss of lower limb muscle strength, activity limitations and reduced quality of life. Moreover, pain sensitization, i.e. increased responsiveness of nociceptive neurons, is another mechanism involved in pain and disability in knee-OA and may contribute to the frequently reported disparities between pain symptoms and radiographic signs of structural damage.
The current non-surgical treatment recommendations in Denmark as well as internationally include offering one or more of: Patient education, dietary advice, weight loss counselling and exercise. Exercise has proven to be a potent stimulus to improve function, and general quality of life in people with knee-OA. Moreover, exercise has been shown to reduce pain sensitization in knee-OA subjects with clinical signs of sensitization. However, there is still a paucity of information on the exact exercise mode for greatest beneficial effects in the knee-OA population.
Reduced lower limb muscle strength has repeatedly been suggested as one of the main working mechanisms behind knee-OA symptoms and quadriceps muscle strength is even suggested as a potential mediating factor in future knee joint space narrowing and longitudinal worsening of knee-joint pain. A recent systematic review revealed upper leg muscle strength along with joint proprioception to be two of the most potent mediating factors in symptomatic knee-OA.
In a randomized controlled trial (RCT) design, this study seeks to investigate potential added benefits of supplementing NEMEX and education with focused knee extensor strength training in patients with knee-OA. 90 patients deemed ineligible for knee replacement surgery will be recruited from the ambulatory setting at Naestved Hospital. By random allocation, patients will be recruited to either 12 weeks (twice weekly) of NEMEX and education + focused knee extensor strength training (intervention group) or 12 weeks (twice weekly) of NEMEX and education only (control group).
The main outcome is the change in KOOS-ADL from baseline to 12-week follow-up. Other outcomes include the remaining KOOS subscales, self-reported pain, health status, physical activity and patient satisfaction, knee extensor muscle power and knee extensor maximal contractile strength, pain sensitization, MRI assessed thigh muscle quality and physical function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group, assessor- and patient blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| NEMEX and education + strength training | Experimental | Other: NEMEX and education + strength trainingParticipants will undergo 12 weeks of twice weekly exercise. Each exercise session will last for 70-90 min. and will consist of 1 hour of specific exercises to optimize sensorimotor control and achieve compensatory functional stability performed in a multiple-joint weight-bearing specific manner. The final part of the session will consist of focused knee extensor strength training performed in gym machines (knee extension \& leg-press) in a combination of low-load fatiguing exercises (knee-extension) followed by high-load exercises (leg-press). Additionally, participants will receive 2 educational sessions, which include disease- and exercise specific counseling. |
| NEMEX and education | Active comparator | Other: NEMEX and educationParticipants will undergo 12 weeks of twice weekly exercise. Each exercise session will last for approximately 60 min. and will consist of 1 hour of specific exercises to optimize sensorimotor control and achieve compensatory functional stability performed in a multiple-joint weight-bearing specific manner. Additionally, participants will receive 2 educational sessions, which include disease- and exercise specific counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with symptomatic and radiographically confirmed knee-OA who are found not eligible for knee replacement surgery by an orthopaedic surgeon in secondary health care.
Key exclusion criteria (7 listed)
- Kellgren \& Lawrence score of <2 on radiography
- Less than "mild" symptoms (mean score >75 in 0-100 KOOS-ADL)
- Medication: Morphine for pain other than knee-joint pain
- Previous ipsilateral knee arthroplasty
- Rheumatoid arthritis
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 |
|---|---|---|
| NEMEX and education + strength trainingAlso: GLA:D + strength trainingOptimizing sensorimotor control and achieving functional stability. Increasing knee extensor muscle strength. Teaching everyday disease management. | Other | NEMEX and education + strength training |
| NEMEX and educationAlso: GLA:DOptimizing sensorimotor control and achieving functional stability. Teaching everyday disease management. | Other | NEMEX and education |
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)
Time frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.
KOOS is a validated and extensively used self-reported outcome measure for people with knee OA. KOOS consists of five subscales, of which the subscale KOOS-ADL will be the primary outcome for this study. KOOS-ADL consists of 17 questions, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). KOOS-ADL has demonstrated a test-retest reliability (ICC) of 0.84-0.94 as well as demonstrating responsiveness to change following physical therapy in knee osteoarthritis.
5 secondary outcomes
Muscle power (watt/kg. bodyweight)
Time frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: Baseline to 6 weeks.
Functional performance (40 m walk & stair-climbs)
Time frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: 6 weeks.
Pain medication
Time frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.
KOOS (remaining four subscales)
Time frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.
AE (adverse events) & Serious Adverse Events (SAE)
Time frame: Primary endpoint: From baseline to 12 weeks.. Secondary endpoint: 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 41772995Pajaniaye JB, Cheret EP, Langvad CH, Holm PM, Skou ST, Larsen JB, Mechkenburg I. Knee osteoarthritis and minimal important change for the nine-step stair climb test. Dan Med J. 2026 Feb 5;73(3):A03250164. doi: 10.61409/A03250164.
- Derived from this study: PubMed 33021580Holm PM, Kemnitz J, Bandholm T, Wernbom M, Schroder HM, Skou ST. Muscle Function Tests as Supportive Outcome Measures for Performance-Based and Self-Reported Physical Function in Patients With Knee Osteoarthritis: Exploratory Analysis of Baseline Data From a Randomized Trial. J Strength Cond Res. 2022 Sep 1;36(9):2635-2642. doi: 10.1519/JSC.0000000000003840. Epub 2020 Oct 5.
- Derived from this study: PubMed 32304510Holm PM, Nyberg M, Wernbom M, Schroder HM, Skou ST. Intrarater Reliability and Agreement of Recommended Performance-Based Tests and Common Muscle Function Tests in Knee Osteoarthritis. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):144-152. doi: 10.1519/JPT.0000000000000266.
- Derived from this study: PubMed 32179197Holm PM, Schroder HM, Wernbom M, Skou ST. Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jun;28(6):744-754. doi: 10.1016/j.joca.2020.02.839. Epub 2020 Mar 13.
- 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.
Pætur M Holm, PT, MSc principal investigator
University of Southern Denmark and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospitals.
Søren T Skou, PT, PhD study chair
University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.
Henrik M Schøder, MD study chair
Naestved Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEMEX and education + strength training and NEMEX and education in people with Knee Osteoarthritis, run by Slagelse Hospital at 1 site in Denmark.
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 7 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL) (time frame: Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.). 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 NCT03215602, which also lists 4 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 2 Sep 2020.