Conservative Management vs. Arthroplasty in Knee Osteoarthritis

NCT06623149 | Enrolling By Invitation

• 1 other identifier: NOK
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 6

Brief 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). 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?

Conditions

Knee Osteoarthrosis

Keywords

arthroplasty; exercise; osteoarthritis; weight loss; pain management; quality of ilfe

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)

Secondary Outcomes (9)

• Oxford Knee Score questionnaire

  Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)

• Oxford Knee Score questionnaire

  After 2 years (month 24)

• Euroqol 5 dimensions questionnaire (EQ5D)

  After 2 years (month 24)

• Satisfaction questionnaire

  After 1 year (month 12)

• Satisfaction questionnaire

  After 2 years (month 24)

Other Outcomes (2)

• Proportion of patients undergoing knee arthroplasty surgery

  5 years

• Costs

  During 2 year from enrollment

Study Arms (2)

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).

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).

Behavioral: Non-Surgical Intervention

Interventions

Non-Surgical Intervention BEHAVIORAL

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

New policy - non-surgical management

Current practice PROCEDURE

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.

Old policy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred to an orthopedic department at a hospital in The Capital Region of Denmark for treatment of knee osteoarthritis.

You may qualify if:

• 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

You may not qualify if:

• Referral declined upon initial vetting.
• Not consenting to sharing data

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (6)

Bispebjerg Frederiksberg Hospital

Copenhagen, Copenhagen, 2000, Denmark

Location

Amager Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

herlev Gentofe Hospital

Copenhagen, 2730, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Bornholms hospital

Rønne, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity; Osteoarthritis; Weight Loss; Agnosia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Marius Henriksen, Professor

  The Parker Institute, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark

  STUDY CHAIR

• Anders Odgaard, Professor

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

DK (6)