Knee OsteoarthrosisNCT06623149
Conservative Management vs. Arthroplasty in Knee Osteoarthritis
An observational study of Knee Osteoarthrosis, run by Marius Henriksen at 6 sites in Denmark.
Trial summary
The goal of this observational study is to learn about the long-term effects of a non-surgical management programme in people with osteoarthritis that are eligible for a knee joint replacement surgery to treat their knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthrosis
- What is being tested?
- Non-Surgical Intervention and Current practice
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 2,500 participants
- Where
- 6 sitesDenmark
- Study dates
- 1 Oct 2024to Apr 2030
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients referred to an orthopedic department at a hospital in The Capital Region of Denmark for treatment of knee osteoarthritis.
Who may be able to join
- A diagnosis of knee osteoarthritis.
- Referral from primary care to an orthopedic department at a hospital in The Capital Region of Denmark for treatment of knee osteoarthritis
Who cannot join
- Referral declined upon initial vetting.
- Not consenting to sharing data
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Denmark6 sites
Bispebjerg Frederiksberg Hospital
Copenhagen, Copenhagen, 2000
Amager Hvidovre Hospital
Copenhagen, Hvidovre, 2650
Rigshospitalet
Copenhagen, 2100
herlev Gentofe Hospital
Copenhagen, 2730
Nordsjællands Hospital
Hillerød, 3400
Bornholms hospital
Rønne
About this study
Official title: Policy-Induced Conservative Management Prioritization Over Arthroplasty On Knee Osteoarthritis Outcomes
The goal of this observational study is to learn about the long-term effects of a non-surgical management programme in people with osteoarthritis that are eligible for a knee joint replacement surgery to treat their knee osteoarthritis (KOA). The main question it aims to answer is:
- Does the non-surgical management programme reduce the proportion of referred patients who are treated with a knee arthroplasty without reducing the health-related quality of life over a two-year perspective?
Read the detailed description
Knee arthroplasty (joint replacement surgery) is a well-established and effective treatment for knee osteoarthritis (KOA). The incidence of knee arthroplasty has increased in Denmark from 8,000 procedures in 2017 to over 15,000 in 2023, partly due to demographic changes, demands, and the procedures effectiveness. However, concerns remain that some patients undergo surgery without having fully explored non-surgical options.
A growing body of research and public declarations suggest that individuals with KOA may benefit from conservative treatment regimens encompassing physical training, weight loss, and pain management strategies. It is implicitly suggested that surgical procedures may be circumvented or deferred well beyond the span of these conservative measures, without adversely impacting patients' quality of life. Such contentions have garnered the attention of decision-makers in the policy realm.
Consequently, a task force under the Capital Region of Denmark has recently mandated a policy shift requiring public hospitals to establish pathways for conservative, non-operative treatment with a duration of three months that patients must complete prior to considering knee arthroplasty. The aim of this policy alteration is to further prioritize conservative management and curtail the frequency of knee arthroplasty procedures while preserving patients' quality of life. Although the number of surgical procedures could be ostensibly minimized by constraining healthcare service provisions and impeding patient access, the patients' quality of life remains the paramount political objective. Consequently, the task force has decided to assess the impact of the policy change by endorsing and initiating a study to monitor quality, as summarized in the current protocol synopsis.
The new policy is introduced in a step-wise manner at the major hospitals in the Capital Region of Denmark (Copenhagen) from October 1st 2024 to January 1st 2025) and this observational study enrols patients at the hospitals before and after implementation of the new policy to facilitate a comparison of the two policies (new vs old). The enrolled patients are followed for 2 years with regular collection of patient-reported outcomes and medical record reviews.
- Conditions
- Knee Osteoarthrosis
- Being tested
- Non-Surgical Intervention, Current practice
- Keywords
- arthroplasty, exercise, osteoarthritis, weight loss, pain management, quality of ilfe
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Osteoarthritis, Weight Loss, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical InterventionBehavioural
After referral from the general practitioner to the orthopedic department, the patient is offered a 3-month non-operative treatment program. The conservative program consists of several elements that are offered on an individual basis. The program consists of 3 main elements:
- Patient education/information
- Specialized exercise supervised by a physiotherapist
- Weight loss counseling with a dietician
Current practiceProcedure or surgery
After referral from the general practitioner to the orthopedic department, the patient is assessed by an orthopedic surgeon in the out-patient clinic according to standard practice with a focus on symptoms, history, physical examination, radiography, and an appraisal of the patient's expectations. If an indication for knee arthroplasty is found, the patient is offered knee arthroplasty, and if the patient accepts the offer, he/she is scheduled according to usual practice. If a patient declines the offer, the patient is informed that the hospital cannot offer any additional service, and the patient is referred back to primary care.
| Study group | Role | What they receive |
|---|---|---|
| Old policy | Individuals with knee osteoarthritis referred from a general practitioner to a participating orthopedic department for assessment of eligibility for knee arthroplasty (surgical joint replacement). Receives: Procedure: Current practice | |
| New policy - non-surgical management | Individuals with knee osteoarthritis referred from a general practitioner to a participating orthopedic department for assessment of eligibility for knee arthroplasty (surgical joint replacement). Receives: Behavioral: Non-Surgical Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients undergoing knee arthroplasty surgery
Percentage of patients who undergo knee replacement surgery in the target joint during the 2-year observation period.
Measured: 2 years
Euroqol 5 dimensions questionnaire (EQ5D)
EQ5D is a standardized patient-reported instrument for use as a measure of health outcome and quality of life. EQ5D is designed for self-completion by respondents and is ideally suited for use in surveys. We will use standard Danish value set to convert the five EQ-5D-5L answers to a single index utility score, and ulti-mately to calculate the QALYs gained by the treatment.
Measured: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)
Secondary outcomes (9)
Oxford Knee Score questionnaire
The Oxford Knee Score (OKS) is a 12-item Patient Reported Outcome questionnaire developed specifically to assess the patients perspective on the outcomes of knee arthroplasty with respect to combined pain and physical function. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Thus, a total score is calculated that ranges from 0 and 48, with 48 indicating the best outcome.
Measured: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)
Oxford Knee Score questionnaire
The Oxford Knee Score (OKS) is a 12-item Patient Reported Outcome questionnaire developed specifically to assess the patients perspective on the outcomes of knee arthroplasty with respect to combined pain and physical function. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Thus, a total score is calculated that ranges from 0 and 48, with 48 indicating the best outcome.
Measured: After 2 years (month 24)
Euroqol 5 dimensions questionnaire (EQ5D)
EQ5D is a standardized patient-reported instrument for use as a measure of health outcome and quality of life. EQ5D is designed for self-completion by respondents and is ideally suited for use in surveys. We will use standard Danish value set to convert the five EQ-5D-5L answers to a single index utility score, and ulti-mately to calculate the QALYs gained by the treatment.
Measured: After 2 years (month 24)
Satisfaction questionnaire
A 5-item questionaire for satisfaction focusing on satisfaction with function of the knee, and the received treatment.
Measured: After 1 year (month 12)
Satisfaction questionnaire
A 5-item questionaire for satisfaction focusing on satisfaction with function of the knee, and the received treatment.
Measured: After 2 years (month 24)
UCLA Physical Activity Scale
The UCLA Activity Scale is a questionnaire used to assess the physical activity levels of patients, particularly those with joint issues, such as knee osteoarthritis or those who have undergone knee arthroplasty. It ranges from 1 to 10, with higher scores indicating higher levels of physical activity. This scale helps clinicians evaluate the functional status of patients and their capacity to perform various physical activities.
Measured: Change from baseline after 2 years (month 24)
UCLA Physical Activity Scale
The UCLA Activity Scale is a questionnaire used to assess the physical activity levels of patients, particularly those with joint issues, such as knee osteoarthritis or those who have undergone knee arthroplasty. It ranges from 1 to 10, with higher scores indicating higher levels of physical activity. This scale helps clinicians evaluate the functional status of patients and their capacity to perform various physical activities.
Measured: Change from baseline after 1 year (month 12)
Copenhagen Knee Range of Motion Scale
The Copenhagen Knee Range of Motion Scale is a clinical tool used to assess and quantify the range of motion in the knee joint. It is particularly useful for evaluating patients with knee osteoarthritis, those undergoing rehabilitation, or those recovering from knee surgeries such as arthroplasty. This scale measures the patient's ability to bend the knee (flexion) and the ability to straighten the knee (extension). The Copenhagen Knee ROM Scale provides a standardized method for healthcare professionals to record knee movement, track progress over time, and guide treatment decisions.
Measured: After 1 year (month 12)
Copenhagen Knee Range of Motion Scale
The Copenhagen Knee Range of Motion Scale is a clinical tool used to assess and quantify the range of motion in the knee joint. It is particularly useful for evaluating patients with knee osteoarthritis, those undergoing rehabilitation, or those recovering from knee surgeries such as arthroplasty. This scale measures the patient's ability to bend the knee (flexion) and the ability to straighten the knee (extension). The Copenhagen Knee ROM Scale provides a standardized method for healthcare professionals to record knee movement, track progress over time, and guide treatment decisions.
Measured: After 2 years (month 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Apr 2027 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthrosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Marius Henriksen, Professor, Study chair, The Parker Institute, Bispebjerg Frederiksberg University Hospital, Copenhagen, DenmarkAnders Odgaard, Professor, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623149
- Sponsor's protocol ID
- NOK
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2024
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Policy-Induced Conservative Management Prioritization Over Arthroplasty On Knee Osteoarthritis Outcomes
- ClinicalTrials.gov ID
- NCT06623149
- Acronym / sponsor ID
- NOK
- Conditions
- Knee Osteoarthrosis
- Keywords
- arthroplasty, exercise, osteoarthritis, weight loss, pain management, quality of ilfe
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 2 Oct 2024 (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 goal of this observational study is to learn about the long-term effects of a non-surgical management programme in people with osteoarthritis that are eligible for a knee joint replacement surgery to treat their knee osteoarthritis (KOA). The main question it aims to answer is:
- Does the non-surgical management programme reduce the proportion of referred patients who are treated with a knee arthroplasty without reducing the health-related quality of life over a two-year perspective?
Detailed description
Knee arthroplasty (joint replacement surgery) is a well-established and effective treatment for knee osteoarthritis (KOA). The incidence of knee arthroplasty has increased in Denmark from 8,000 procedures in 2017 to over 15,000 in 2023, partly due to demographic changes, demands, and the procedures effectiveness. However, concerns remain that some patients undergo surgery without having fully explored non-surgical options.
A growing body of research and public declarations suggest that individuals with KOA may benefit from conservative treatment regimens encompassing physical training, weight loss, and pain management strategies. It is implicitly suggested that surgical procedures may be circumvented or deferred well beyond the span of these conservative measures, without adversely impacting patients' quality of life. Such contentions have garnered the attention of decision-makers in the policy realm.
Consequently, a task force under the Capital Region of Denmark has recently mandated a policy shift requiring public hospitals to establish pathways for conservative, non-operative treatment with a duration of three months that patients must complete prior to considering knee arthroplasty. The aim of this policy alteration is to further prioritize conservative management and curtail the frequency of knee arthroplasty procedures while preserving patients' quality of life. Although the number of surgical procedures could be ostensibly minimized by constraining healthcare service provisions and impeding patient access, the patients' quality of life remains the paramount political objective. Consequently, the task force has decided to assess the impact of the policy change by endorsing and initiating a study to monitor quality, as summarized in the current protocol synopsis.
The new policy is introduced in a step-wise manner at the major hospitals in the Capital Region of Denmark (Copenhagen) from October 1st 2024 to January 1st 2025) and this observational study enrols patients at the hospitals before and after implementation of the new policy to facilitate a comparison of the two policies (new vs old). The enrolled patients are followed for 2 years with regular collection of patient-reported outcomes and medical record reviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old policy | – | Procedure: Current practiceIndividuals with knee osteoarthritis referred from a general practitioner to a participating orthopedic department for assessment of eligibility for knee arthroplasty (surgical joint replacement). |
| New policy - non-surgical management | – | Behavioral: Non-Surgical InterventionIndividuals with knee osteoarthritis referred from a general practitioner to a participating orthopedic department for assessment of eligibility for knee arthroplasty (surgical joint replacement). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients referred to an orthopedic department at a hospital in The Capital Region of Denmark for treatment of knee osteoarthritis.
Key inclusion criteria (2 listed)
- A diagnosis of knee osteoarthritis.
- Referral from primary care to an orthopedic department at a hospital in The Capital Region of Denmark for treatment of knee osteoarthritis
Key exclusion criteria (2 listed)
- Referral declined upon initial vetting.
- Not consenting to sharing data
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 |
|---|---|---|
| Non-Surgical InterventionAfter referral from the general practitioner to the orthopedic department, the patient is offered a 3-month non-operative treatment program. The conservative program consists of several elements that are offered on an individual basis. The program consists of 3 main elements: * Patient education/information * Specialized exercise supervised by a physiotherapist * Weight loss counseling with a dietician | Behavioural | New policy - non-surgical management |
| Current practiceAfter referral from the general practitioner to the orthopedic department, the patient is assessed by an orthopedic surgeon in the out-patient clinic according to standard practice with a focus on symptoms, history, physical examination, radiography, and an appraisal of the patient's expectations. If an indication for knee arthroplasty is found, the patient is offered knee arthroplasty, and if the patient accepts the offer, he/she is scheduled according to usual practice. If a patient declines the offer, the patient is informed that the hospital cannot offer any additional service, and the patient is referred back to primary care. | Procedure or surgery | Old policy |
Primary outcome
Proportion of patients undergoing knee arthroplasty surgery
Time frame: 2 years
Percentage of patients who undergo knee replacement surgery in the target joint during the 2-year observation period.
Euroqol 5 dimensions questionnaire (EQ5D)
Time frame: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)
EQ5D is a standardized patient-reported instrument for use as a measure of health outcome and quality of life. EQ5D is designed for self-completion by respondents and is ideally suited for use in surveys. We will use standard Danish value set to convert the five EQ-5D-5L answers to a single index utility score, and ulti-mately to calculate the QALYs gained by the treatment.
9 secondary outcomes
Oxford Knee Score questionnaire
Time frame: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)
Oxford Knee Score questionnaire
Time frame: After 2 years (month 24)
Euroqol 5 dimensions questionnaire (EQ5D)
Time frame: After 2 years (month 24)
Satisfaction questionnaire
Time frame: After 1 year (month 12)
Satisfaction questionnaire
Time frame: After 2 years (month 24)
UCLA Physical Activity Scale
Time frame: Change from baseline after 2 years (month 24)
UCLA Physical Activity Scale
Time frame: Change from baseline after 1 year (month 12)
Copenhagen Knee Range of Motion Scale
Time frame: After 1 year (month 12)
Copenhagen Knee Range of Motion Scale
Time frame: After 2 years (month 24)
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthrosis
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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.
Marius Henriksen, Professor study chair
The Parker Institute, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark
Anders Odgaard, Professor study chair
Copenhagen University Hospital, Rigshospitalet
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthrosis, run by Marius Henriksen at 6 sites 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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?
Proportion of patients undergoing knee arthroplasty surgery (time frame: 2 years). The study lists 2 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 16 Jun 2026.