Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643845
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Can Multimodal Medical Strategies Can Delay Total Knee Replacement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Is Non Surgical CaRE Using Treat to Target Multimodal MeDIcal Strategies ABLE to Delay or Avoid Total Knee Replacement INCREDIBLE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
INCREDIBLE
Brief Summary:
Knee is the most common site of osteoarthritis Treatment of knee osteoarthritis starts with a full course of medical therapy followed by surgery to replace the knee with a prosthesis if this strategy fails or in advanced cases However the new recommendations of the French rheumatology society which evaluate the various treatments and position them in the treatment plan are not well known and the definition of a complete treatment remains unclear The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal generally analgesics and corticosteroid or hyaluronic acid infiltrations The goal of this study is to to select patients most likely to gain from surgery and to develop strategies that avoid the need for major surgery
Detailed Description:
Knee is the most common site of osteoarthritis Treatment of knee osteoarthritis starts with a full course of medical therapy followed by surgery to replace the knee with a prosthesis if this strategy fails or in advanced cases
However the new recommendations of the French rheumatology society which evaluate the various treatments and position them in the treatment plan are not well known and the definition of a complete treatment remains unclear The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal generally analgesics and corticosteroid or hyaluronic acid infiltrations
Yet medical treatment has proved effective suggesting that it could prevent a significant number of total knee arthroplasties In addition osteoarthritis of the knee is associated with various co-morbidities diabetes cardiovascular that medical treatment can minimize diet physical activity
The effectiveness of knee prostheses has been demonstrated but up to 20 of patients continue to experience pain and surgical procedures induce rare but serious events Prostheses can also be revised and are expensive
This research is designed for patients suffering from femoro-tibial osteoarthritis who have been proposed total knee replacement by a surgeon and aims to develop strategies to avoid the need for major surgery until the medical treatment arsenal adapted to the patients situation has been tried
In the treatment of osteoarthritis the impact of shared decision-making between rheumatologists orthopaedic surgeons and the patient in the event of incomplete medical treatment has been shown to be important as the decision is often modified after discussion
The main objective of this prospective randomized pragmatic non-blinded multicenter study is to investigate whether shared decision-making coupled with multimodal medical strategies delays surgery by at least 2 years in most patients with non-inferiority on pain and function lower cost and fewer serious adverse events compared with total knee arthroplasty from the outset
However the new recommendations of the French rheumatology society which evaluate the various treatments and position them in the treatment plan are not well known and the definition of a complete treatment remains unclear The vast majority of patients are therefore referred to a surgeon after having tried a small part of the therapeutic arsenal generally analgesics and corticosteroid or hyaluronic acid infiltrations
Yet medical treatment has proved effective suggesting that it could prevent a significant number of total knee arthroplasties In addition osteoarthritis of the knee is associated with various co-morbidities diabetes cardiovascular that medical treatment can minimize diet physical activity
The effectiveness of knee prostheses has been demonstrated but up to 20 of patients continue to experience pain and surgical procedures induce rare but serious events Prostheses can also be revised and are expensive
This research is designed for patients suffering from femoro-tibial osteoarthritis who have been proposed total knee replacement by a surgeon and aims to develop strategies to avoid the need for major surgery until the medical treatment arsenal adapted to the patients situation has been tried
In the treatment of osteoarthritis the impact of shared decision-making between rheumatologists orthopaedic surgeons and the patient in the event of incomplete medical treatment has been shown to be important as the decision is often modified after discussion
The main objective of this prospective randomized pragmatic non-blinded multicenter study is to investigate whether shared decision-making coupled with multimodal medical strategies delays surgery by at least 2 years in most patients with non-inferiority on pain and function lower cost and fewer serious adverse events compared with total knee arthroplasty from the outset
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