Clinical trial NCT06623149: Conservative Management vs. Arthroplasty in Knee Osteoarthritis
Official title: Policy-Induced Conservative Management Prioritization Over Arthroplasty On Knee Osteoarthritis Outcomes
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Knee Osteoarthrosis
Keywords: arthroplasty
exercise
osteoarthritis
weight loss
pain management
quality of ilfe
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?

Detailed description: Knee arthroplasty (joint replacement surgery) is a well-established and effective treatment for knee osteoarthritis (KOA). The incidence of knee arthroplasty has increased in Denmark from 8,000 procedures in 2017 to over 15,000 in 2023, partly due to demographic changes, demands, and the procedures effectiveness. However, concerns remain that some patients undergo surgery without having fully explored non-surgical options.

A growing body of research and public declarations suggest that individuals with KOA may benefit from conservative treatment regimens encompassing physical training, weight loss, and pain management strategies. It is implicitly suggested that surgical procedures may be circumvented or deferred well beyond the span of these conservative measures, without adversely impacting patients' quality of life. Such contentions have garnered the attention of decision-makers in the policy realm.

Consequently, a task force under the Capital Region of Denmark has recently mandated a policy shift requiring public hospitals to establish pathways for conservative, non-operative treatment with a duration of three months that patients must complete prior to considering knee arthroplasty. The aim of this policy alteration is to further prioritize conservative management and curtail the frequency of knee arthroplasty procedures while preserving patients' quality of life. Although the number of surgical procedures could be ostensibly minimized by constraining healthcare service provisions and impeding patient access, the patients' quality of life remains the paramount political objective. Consequently, the task force has decided to assess the impact of the policy change by endorsing and initiating a study to monitor quality, as summarized in the current protocol synopsis.

The new policy is introduced in a step-wise manner at the major hospitals in the Capital Region of Denmark (Copenhagen) from October 1st 2024 to January 1st 2025) and this observational study enrols patients at the hospitals before and after implementation of the new policy to facilitate a comparison of the two policies (new vs old). The enrolled patients are followed for 2 years with regular collection of patient-reported outcomes and medical record reviews.

Eligibility criteria: 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 outcomes:
measure: Proportion of patients undergoing knee arthroplasty surgery
timeFrame: 2 years
measure: Euroqol 5 dimensions questionnaire (EQ5D)
timeFrame: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)
Secondary outcomes:
measure: Oxford Knee Score questionnaire
timeFrame: Average over 2 years (collected at month 0 (enrollment), 3, 6, 9, 12, 18 and 24)
measure: Oxford Knee Score questionnaire
timeFrame: After 2 years (month 24)
measure: Euroqol 5 dimensions questionnaire (EQ5D)
timeFrame: After 2 years (month 24)
measure: Satisfaction questionnaire
timeFrame: After 1 year (month 12)
measure: Satisfaction questionnaire
timeFrame: After 2 years (month 24)
measure: UCLA Physical Activity Scale
timeFrame: Change from baseline after 2 years (month 24)
measure: UCLA Physical Activity Scale
timeFrame: Change from baseline after 1 year (month 12)
measure: Copenhagen Knee Range of Motion Scale
timeFrame: After 1 year (month 12)
measure: Copenhagen Knee Range of Motion Scale
timeFrame: After 2 years (month 24)
Other outcomes:
measure: Proportion of patients undergoing knee arthroplasty surgery
timeFrame: 5 years
measure: Costs
timeFrame: During 2 year from enrollment
Locations:
city: Copenhagen
country: Denmark
facility: Amager Hvidovre Hospital
state: Hvidovre
city: Copenhagen
country: Denmark
facility: Bispebjerg Frederiksberg Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: herlev Gentofe Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Rønne
country: Denmark
facility: Bornholms hospital
Study officials:
affiliation: The Parker Institute, Bispebjerg Frederiksberg University Hospital, Copenhagen, Denmark
name: Marius Henriksen, Professor
role: STUDY_CHAIR
affiliation: Rigshospitalet, Denmark
name: Anders Odgaard, Professor
role: STUDY_CHAIR
References: