Skip to content

The Right Treatment for the Right Patient at the Right Time. A Study Following 5,000 Patients With Knee Osteoarthritis

The Right Treatment for the Right Patient at the Right Time - A Prospective Cohort Study of 5,000 Patients With Knee Osteoarthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03746184
Acronym
TREATright
Enrollment
3507
Registered
2018-11-19
Start date
2018-10-23
Completion date
2023-04-27
Last updated
2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

precision medicine, Patient-Specific Modeling

Brief 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. 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.

Interventions

OTHERTreatment course

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.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER
Naestved Hospital
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
VIVE - The Danish Center for Social Science Research
CollaboratorOTHER
University of Southern Denmark
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* primary referrals to one of two orthopedic department's outpatient clinics due to knee osteoarthritis

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Patient Acceptable Symptom State (PASS)2 years after inclusionPatients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
Treatment Failure2 years after inclusionPatients 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.

Secondary

MeasureTime frameDescription
Patient Acceptable Symptom State (PASS)6 months after inclusionPatients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.
Treatment Failure6 months after inclusionPatients 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.
Minimal Important Change6 months and 2 years after inclusionAn 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.
Oxford Knee Score (OKS), range from 0 (worst) to 48 (best)6 months and 2 years after inclusionPatient self-reported average knee pain and function during the past four weeks calculated from a validated 12-item questionnaire.

Countries

Denmark

Contacts

STUDY_CHAIRAnders Troelsen, Professor

Copenhagen University Hospital, Hvidovre

STUDY_CHAIRLina H Ingelsrud, PhD

Copenhagen University Hospital, Hvidovre

STUDY_CHAIRHenrik M Schroeder, Asst. Prof.

Næstved Sygehus, Denmark

STUDY_CHAIRSøren T Skou, Assoc. Prof.

Næstved-Slagelse-Ringsted Hospitals AND University of Southern Denmark

STUDY_CHAIRThomas Bandholm, Professor

University of Copenhagen AND Copenhagen University Hospital Hvidovre, Denmark

STUDY_CHAIRJakob Kjellberg, Professor

VIVE - The Danish Centre of Applied Social Science, Denmark

STUDY_CHAIRSusanne Reventlow, Professor

University of Copenhagen

STUDY_CHAIRAnne Møller, Asst. Prof.

University of Copenhagen

STUDY_CHAIRSimon M Bruhn, M.Sc.

Copenhagen University Hospital, Hvidovre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026