Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623149
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Conservative Management Vs Arthroplasty in Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Policy-Induced Conservative Management Prioritization Over Arthroplasty on Knee Osteoarthritis Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the long-term effects of a non-surgical management program 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 os
- Does the non-surgical management program reduce the number of knee surgeries without reducing the health-related quality of life over a two-year perspective
- Does the non-surgical management program reduce the number of knee surgeries without reducing the health-related quality of life over a two-year perspective
Detailed Description:
Knee arthroplasty surgical joint replacement surgery is a well-established and effective treatment for knee osteoarthritis KOA The incidence of knee arthroplasty has increased in Denmark from 8000 procedures in 2017 to over 11000 in 2022 partly due to demographic changes demands and the procedure39s 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 might 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 enrolls 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
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 might 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 enrolls 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None