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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03746184
Recruitment Status : Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : March 16, 2022
Sponsor:
Collaborators:
Naestved Hospital
University of Copenhagen
VIVE - The Danish Center for Social Science Research
University of Southern Denmark
Information provided by (Responsible Party):
Anders Troelsen, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment
Knee Osteoarthritis Other: Treatment course

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Right Treatment for the Right Patient at the Right Time - A Prospective Cohort Study of 5,000 Patients With Knee Osteoarthritis
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
Knee osteoarthritis
Treatment course
Other: Treatment 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Patient Acceptable Symptom State (PASS) [ Time Frame: 6 months after inclusion ]
    Patients answer yes/no to a PASS question asking whether they consider the current symptom state to be acceptable.

  2. Treatment Failure [ Time Frame: 6 months 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.

  3. Minimal Important Change [ Time Frame: 6 months and 2 years after inclusion ]
    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.

  4. Oxford Knee Score (OKS), range from 0 (worst) to 48 (best) [ Time Frame: 6 months and 2 years after inclusion ]
    Patient self-reported average knee pain and function during the past four weeks calculated from a validated 12-item questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746184


Locations
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Denmark
Department of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Department of Orthopaedic Surgery, Næstved Sygehus
Næstved, Denmark, 4700
Sponsors and Collaborators
Hvidovre University Hospital
Naestved Hospital
University of Copenhagen
VIVE - The Danish Center for Social Science Research
University of Southern Denmark
Investigators
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Study Chair: Anders Troelsen, Professor Copenhagen University Hospital, Hvidovre, Denmark
Study Chair: Lina H Ingelsrud, PhD Copenhagen University Hospital, Hvidovre, Denmark
Study Chair: Henrik M Schroeder, Asst. Prof. Næstved Sygehus, Denmark
Study Chair: Søren T Skou, Assoc. Prof. Næstved-Slagelse-Ringsted Hospitals AND University of Southern Denmark
Study Chair: Thomas Bandholm, Professor University of Copenhagen AND Copenhagen University Hospital Hvidovre, Denmark
Study Chair: Jakob Kjellberg, Professor VIVE - The Danish Centre of Applied Social Science, Denmark
Study Chair: Susanne Reventlow, Professor University of Copenhagen
Study Chair: Anne Møller, Asst. Prof. University of Copenhagen
Study Chair: Simon M Bruhn, M.Sc. Copenhagen University Hospital, Hvidovre, Denmark
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Troelsen, Professor, consultant, dr.med., PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT03746184    
Other Study ID Numbers: CAGROAD_TREATright_2018
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anders Troelsen, Hvidovre University Hospital:
precision medicine
Patient-Specific Modeling
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases