Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)

May 19, 2026 updated by: University Hospital, Brest

Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 patient's 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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-90 years old
  • Femoro-tibial osteoarthritis Kellgren stage stage≥ 2 without laxity in extension;
  • A proposal of total knee replacement by a surgeon;
  • No corticosteroid joint injection within 3 months;
  • Visual analogic score pain (VAS) >40/100 but <90/100 or Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index function sub scale >40/100 at inclusion;
  • Wish to discuss medical care;
  • Able to consent and having signed a consent form.

Exclusion Criteria:

  • Contraindication or no indication to surgery or medical care (severe infection for example)
  • Inflammatory arthritis
  • Lack of social insurance
  • Symptomatic (VAS pain >40) contralateral knee or hip osteoarthritis (with or without replacement)
  • Pregnant or breastfeeding woman
  • Patient under court protection, guardianship, curatorship
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal medical care arm
In the medical care arm, rheumatologists will list previous treatment, ongoing treatment and then order validated treatment (corticosteroid or hyaluronic acid joint injection if necessary, physical activity and weight loss in the event of obesity, other non-drug treatments (insole, orthosis) as well as other drug treatments (pain killers or non steroidal anti-inflammatory drugs) including validated tools (personalized program, filmed sessions and digital exercise media for regular practice at home, motivational e-mails). At least one modification will be discussed in each domain (physical activity, weight loss, insole, orthosis, assistive device when walking, joint injection, pills -pain killer acetaminophen and opioids- nonsteroidal anti inflammatory drugs -with classical rules - and others)
Other: Medical and non-medical treatments
In the medical care arm, patients will follow multimodal medical strategies to prevent surgery in a population of patients with knee osteoarthritis having a first indication of knee prosthesis
Active Comparator: Surgery arm
In the surgery arm, patients will have to plan, as initially suggested, their surgery (total knee arthroplasty)
Procedure: arthroplasty
In the surgery arm, patients will have their surgery (arthroplasty), as originally planned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multimodal medical care osteoarthritis is non inferior (with a threshold of 15% for pain and function) to total knee arthroplasty in symptomatic radiographic knee osteoarthritis.
Time Frame: 2 years

The outcome relates to two scales which constitute the composite principal endpoint;

  • Visual Analogic Score pain, VAS (scale 0-100)
  • Western Ontario and McMaster Universities function, WOMAC (scale 0-100) Success is defined by a VAS AND WOMAC scale ≤40/100 at 2 years Failure is defined by a VAS pain OR WOMAC scale > 40/100 at 2 years.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study the proportion of delayed surgery in the medical group
Time Frame: 2 years
Number of cumulated surgery (yes/no) by month in the medical group
2 years
Study the proportion of patients with severe events induced by surgery
Time Frame: 2 years
Number of severe events (Who classification) in the surgical group.
2 years
Analyze the impact of physical activity on change of body mass by arm in the randomized population.
Time Frame: 2 years
Perform analyses of body mass on whole body densitometry
2 years
To compare analgesic use by arm.
Time Frame: 2 years
Analgesic use by class in milligram.
2 years
To compare the 0-2 years cost using the National Health Data System between the 2 groups.
Time Frame: 0-2 years
Cost in euro between 0-2
0-2 years
To compare the 2-5 cost using the National Health Data System between the 2 groups.
Time Frame: 2-5 years
Cost in euro between 2-5 years
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Alain Saraux, Pr, CHU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2025

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

October 14, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC23.0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning five years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access request will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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