Conservative Management vs. Arthroplasty in Knee Osteoarthritis

NCT ID: NCT06623149

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2030-04-30

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.

Conditions

Knee Osteoarthrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Current practice

Intervention Type: 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.

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).

Non-Surgical Intervention

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marius Henriksen

OTHER

Sponsor Role: lead

Responsible Party

Marius Henriksen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marius Henriksen, Professor

Role: STUDY_CHAIR

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

Anders Odgaard, Professor

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Bispebjerg Frederiksberg Hospital

Copenhagen, Copenhagen, Denmark

Amager Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Rigshospitalet

Copenhagen, , Denmark

herlev Gentofe Hospital

Copenhagen, , Denmark

Nordsjællands Hospital

Hillerød, , Denmark

Bornholms hospital

Rønne, , Denmark

Countries

Denmark

Other Identifiers

NOK

Identifier Type: -

Identifier Source: org_study_id