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Enrolling by invitation Observational

Conservative Management vs. Arthroplasty in Knee Osteoarthritis

NCT06623149 · tracked via the Priya Life Science Denmark tracker
Sponsor
Marius Henriksen
Phase
Observational
Started
2024-10-01
Last updated
2026-06-16

Condition(s) studied

Knee Osteoarthrosis

Investigational drug(s) / intervention(s)

Non-Surgical InterventionCurrent practice

Non-Surgical Intervention: 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 practice: 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 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?

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * Referral declined upon initial vetting. * Not consenting to sharing data

Primary outcome measure(s)

  • Proportion of patients undergoing knee arthroplasty surgery — 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) — 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.

Trial sites (6)

FacilityCityRegionStatus
Bispebjerg Frederiksberg Hospital Copenhagen Copenhagen
Amager Hvidovre Hospital Copenhagen Hvidovre
Rigshospitalet Copenhagen Denmark
herlev Gentofe Hospital Copenhagen Denmark
Nordsjællands Hospital Hillerød Denmark
Bornholms hospital Rønne Denmark

More Marius Henriksen trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06623149 on ClinicalTrials.gov ↗ ← All trials in Denmark