Knee OsteoarthritisTREATrightNCT03746184
The Right Treatment for the Right Patient at the Right Time. A Study Following 5,000 Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The treatment that patients with knee OA are offered varies largely. There is a need for more evidence-based individualized guidance to treatment choice for knee osteoarthritis. This study will register and evaluate the course and outcome of treatment in 5,000 patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Treatment course
- How many people
- 3,507 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Oct 2018to 27 Apr 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients with primary referrals to one of two public hospitals orthopedic department's outpatient clinics due to knee osteoarthritis are consecutively invited to participate. The two hospitals cover the larger part of Zealand in Denmark.
Who may be able to join
- primary referrals to one of two orthopedic department's outpatient clinics due to knee osteoarthritis
Who cannot join
- previous total or unicompartmental knee replacement
- osteotomy around the study knee
- unable to read or write Danish
- patients who decline to answer the questionnaire at inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
About this study
Official title: The Right Treatment for the Right Patient at the Right Time - A Prospective Cohort Study of 5,000 Patients With Knee Osteoarthritis
The treatment that patients with knee OA are offered varies largely. There is a need for more evidence-based individualized guidance to treatment choice for knee osteoarthritis. This study will register and evaluate the course and outcome of treatment in 5,000 patients with knee osteoarthritis. The understanding of knee OA treatment will advance in three ways: Firstly, by describing the different treatment pathways that are currently being used for knee OA. Secondly, by identifying wich individual factors that may impact the outcome of the treatment course. And finally, by conducting the economic burden related to different treatment modalities.
Read the detailed description
The problem: Knee Osteoarthritis (OA), the most common form of arthritis, is a chronic, widespread disease with a steadily increasing prevalence that places a major economic burden on the society. Patients with knee OA suffer from chronic knee pain and functional disabilities. The treatment that patients with knee OA are offered varies largely, and is often not in coherence with clinical guidelines. The guidelines recommend patient education, exercise, and weight control as core interventions for all patients with knee OA and surgical intervention for end-stage knee OA. However, the timing of surgery is debated, and whether the outcome of different treatment strategies depend on individual factors such as the patients symptoms, OA severity, or prior treatment, has not been established.
The solution: This large-scale study aims at improving the understanding of which treatment should be offered to which patient with knee OA at which time. The study is an interdisciplinary, collaborative effort, including orthopaedic surgeons, physiotherapists and general practitioners from two different regions in Denmark. At least 5,000 patients with primary referrals to orthopaedic surgeons due to knee OA, at two public hospitals, will be recruited through a two-year inclusion period. Patients' prior treatment and symptom severity will be registered at the first consultation with the orthopaedic surgeon using a patient self-reported questionnaire. OA severity will be defined on plain standing knee radiographs using a well-established classification system. The course of treatment will be registered after 6 months and 2 years through a self-reported questionnaire with additional questions asking whether patients can accept their current symptom state, or, if not, whether they consider the treatment to have failed.
Societal impact and clinical implications: The understanding of knee OA treatment will advance in three ways: Firstly, our results will improve the overview by describing the different treatment pathways that are currently being used for knee OA. Secondly, predictors of good and poor treatment outcomes of different treatment modalities, or combinations hereof will be identified. And finally, the cost-effectiveness of different treatment modalities will be evaluated. These results will be used to develop a treatment algorithm to help patients with knee OA and clinicians to tailor the right treatment at the right time through shared decision-making.
- Conditions
- Knee Osteoarthritis
- Being tested
- Treatment course
- Keywords
- precision medicine, Patient-Specific Modeling
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment courseOther
Pursued treatment for knee OA, including type of health care provider, time period of treatment course, and types of treatments received, will be recorded via the patient-reported questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis | Treatment course Receives: Other: Treatment course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Acceptable Symptom State (PASS)
Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
Measured: 2 years after inclusion
Treatment Failure
Patients who answer "no" to the PASS question will also answer "yes/no" to a question about whether they consider the treatment received to have failed.
Measured: 2 years after inclusion
Secondary outcomes (4)
Patient Acceptable Symptom State (PASS)
Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
Measured: 6 months after inclusion
Treatment Failure
Patients who answer "no" to the PASS question will also answer "yes/no" to a question about whether they consider the treatment received to have failed.
Measured: 6 months after inclusion
Minimal Important Change
An anchor question asking about the degree and importance of change in knee-pain and function will be answered on a 7-level Likert scale ranging from better, an important improvement to worse, an important deterioration.
Measured: 6 months and 2 years after inclusion
Oxford Knee Score (OKS), range from 0 (worst) to 48 (best)
Patient self-reported average knee pain and function during the past four weeks calculated from a validated 12-item questionnaire.
Measured: 6 months and 2 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start23 Oct 2018
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,507 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital, University of Copenhagen, VIVE - The Danish Center for Social Science Research, University of Southern Denmark
- Responsible party
- Principal investigator, Anders Troelsen, Hvidovre University Hospital
- Investigators
- Anders Troelsen, Professor, Study chair, Copenhagen University Hospital, HvidovreLina H Ingelsrud, PhD, Study chair, Copenhagen University Hospital, HvidovreHenrik M Schroeder, Asst. Prof., Study chair, Næstved Sygehus, DenmarkSøren T Skou, Assoc. Prof., Study chair, Næstved-Slagelse-Ringsted Hospitals AND University of Southern DenmarkThomas Bandholm, Professor, Study chair, University of Copenhagen AND Copenhagen University Hospital Hvidovre, DenmarkJakob Kjellberg, Professor, Study chair, VIVE - The Danish Centre of Applied Social Science, DenmarkSusanne Reventlow, Professor, Study chair, University of CopenhagenAnne Møller, Asst. Prof., Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746184
- Sponsor's protocol ID
- CAGROAD_TREATright_2018
- Acronym
- TREATright
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2018
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Decision in pending on whether the total database with all anonymised data will be transferred to the Danish National Archives' Collections once the study is completed.
Publications
Bruhn SM, Skou ST, Harris LK, Bandholm T, Moller A, Schroder HM, Troelsen A, Ingelsrud LH. Usage of guideline-adherent core treatments for knee osteoarthritis before and after consulting an orthopaedic surgeon: A prospective cohort study. Osteoarthr Cartil Open. 2023 Sep 28;5(4):100411. doi: 10.1016/j.ocarto.2023.100411. eCollection 2023 Dec.
PubMed 37818279Bruhn SM, Ingelsrud LH, Bandholm T, Skou ST, Schroder HM, Reventlow S, Moller A, Kjellberg J, Kallemose T, Troelsen A. Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study. BMJ Open. 2021 Jul 7;11(7):e048411. doi: 10.1136/bmjopen-2020-048411.
PubMed 34233992
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Right Treatment for the Right Patient at the Right Time - A Prospective Cohort Study of 5,000 Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03746184
- Acronym / sponsor ID
- TREATright / CAGROAD_TREATright_2018
- Conditions
- Knee Osteoarthritis
- Keywords
- precision medicine, Patient-Specific Modeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,507 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Naestved Hospital, University of Copenhagen, VIVE - The Danish Center for Social Science Research, University of Southern Denmark
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 19 Nov 2018 (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 treatment that patients with knee OA are offered varies largely. There is a need for more evidence-based individualized guidance to treatment choice for knee osteoarthritis. This study will register and evaluate the course and outcome of treatment in 5,000 patients with knee osteoarthritis. The understanding of knee OA treatment will advance in three ways: Firstly, by describing the different treatment pathways that are currently being used for knee OA. Secondly, by identifying wich individual factors that may impact the outcome of the treatment course. And finally, by conducting the economic burden related to different treatment modalities.
Detailed description
The problem: Knee Osteoarthritis (OA), the most common form of arthritis, is a chronic, widespread disease with a steadily increasing prevalence that places a major economic burden on the society. Patients with knee OA suffer from chronic knee pain and functional disabilities. The treatment that patients with knee OA are offered varies largely, and is often not in coherence with clinical guidelines. The guidelines recommend patient education, exercise, and weight control as core interventions for all patients with knee OA and surgical intervention for end-stage knee OA. However, the timing of surgery is debated, and whether the outcome of different treatment strategies depend on individual factors such as the patients symptoms, OA severity, or prior treatment, has not been established.
The solution: This large-scale study aims at improving the understanding of which treatment should be offered to which patient with knee OA at which time. The study is an interdisciplinary, collaborative effort, including orthopaedic surgeons, physiotherapists and general practitioners from two different regions in Denmark. At least 5,000 patients with primary referrals to orthopaedic surgeons due to knee OA, at two public hospitals, will be recruited through a two-year inclusion period. Patients' prior treatment and symptom severity will be registered at the first consultation with the orthopaedic surgeon using a patient self-reported questionnaire. OA severity will be defined on plain standing knee radiographs using a well-established classification system. The course of treatment will be registered after 6 months and 2 years through a self-reported questionnaire with additional questions asking whether patients can accept their current symptom state, or, if not, whether they consider the treatment to have failed.
Societal impact and clinical implications: The understanding of knee OA treatment will advance in three ways: Firstly, our results will improve the overview by describing the different treatment pathways that are currently being used for knee OA. Secondly, predictors of good and poor treatment outcomes of different treatment modalities, or combinations hereof will be identified. And finally, the cost-effectiveness of different treatment modalities will be evaluated. These results will be used to develop a treatment algorithm to help patients with knee OA and clinicians to tailor the right treatment at the right time through shared decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis | – | Other: Treatment courseTreatment course |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with primary referrals to one of two public hospitals orthopedic department's outpatient clinics due to knee osteoarthritis are consecutively invited to participate. The two hospitals cover the larger part of Zealand in Denmark.
Key inclusion criteria (1 listed)
- primary referrals to one of two orthopedic department's outpatient clinics due to knee osteoarthritis
Key exclusion criteria (4 listed)
- previous total or unicompartmental knee replacement
- osteotomy around the study knee
- unable to read or write Danish
- patients who decline to answer the questionnaire at inclusion
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 |
|---|---|---|
| Treatment coursePursued treatment for knee OA, including type of health care provider, time period of treatment course, and types of treatments received, will be recorded via the patient-reported questionnaire. | Other | Knee osteoarthritis |
Primary outcome
Patient Acceptable Symptom State (PASS)
Time frame: 2 years after inclusion
Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
Treatment Failure
Time frame: 2 years after inclusion
Patients who answer "no" to the PASS question will also answer "yes/no" to a question about whether they consider the treatment received to have failed.
4 secondary outcomes
Patient Acceptable Symptom State (PASS)
Time frame: 6 months after inclusion
Treatment Failure
Time frame: 6 months after inclusion
Minimal Important Change
Time frame: 6 months and 2 years after inclusion
Oxford Knee Score (OKS), range from 0 (worst) to 48 (best)
Time frame: 6 months and 2 years after inclusion
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 18 Sep 2026.
- Derived from this study: PubMed 37818279Bruhn SM, Skou ST, Harris LK, Bandholm T, Moller A, Schroder HM, Troelsen A, Ingelsrud LH. Usage of guideline-adherent core treatments for knee osteoarthritis before and after consulting an orthopaedic surgeon: A prospective cohort study. Osteoarthr Cartil Open. 2023 Sep 28;5(4):100411. doi: 10.1016/j.ocarto.2023.100411. eCollection 2023 Dec.
- Derived from this study: PubMed 34233992Bruhn SM, Ingelsrud LH, Bandholm T, Skou ST, Schroder HM, Reventlow S, Moller A, Kjellberg J, Kallemose T, Troelsen A. Disentangling treatment pathways for knee osteoarthritis: a study protocol for the TREATright study including a prospective cohort study, a qualitative study and a cost-effectiveness study. BMJ Open. 2021 Jul 7;11(7):e048411. doi: 10.1136/bmjopen-2020-048411.
- Individual participant dataSharing planned: Undecided. Decision in pending on whether the total database with all anonymised data will be transferred to the Danish National Archives' Collections once the study is completed.
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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.
Anders Troelsen, Professor study chair
Copenhagen University Hospital, Hvidovre
Lina H Ingelsrud, PhD study chair
Copenhagen University Hospital, Hvidovre
Henrik M Schroeder, Asst. Prof. study chair
Næstved Sygehus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Hvidovre University 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 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: finished, as of the sponsor's last update on 18 Sep 2026. 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?
Patient Acceptable Symptom State (PASS) (time frame: 2 years after inclusion). 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?
On the ClinicalTrials.gov record for NCT03746184, which also lists 2 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 18 Sep 2026.