Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement?
INCREDIBLE
1 other identifier
interventional
1,000
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedStudy Start
First participant enrolled
October 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2031
May 22, 2026
May 1, 2026
5.5 years
August 19, 2024
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 Outcomes (6)
Study the proportion of delayed surgery in the medical group
2 years
Study the proportion of patients with severe events induced by surgery
2 years
Analyze the impact of physical activity on change of body mass by arm in the randomized population.
2 years
To compare analgesic use by arm.
2 years
To compare the 0-2 years cost using the National Health Data System between the 2 groups.
0-2 years
- +1 more secondary outcomes
Study Arms (2)
Multimodal medical care arm
EXPERIMENTALIn 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)
Surgery arm
ACTIVE COMPARATORIn the surgery arm, patients will have to plan, as initially suggested, their surgery (total knee arthroplasty)
Interventions
In the surgery arm, patients will have their surgery (arthroplasty), as originally planned.
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
Eligibility Criteria
You may qualify if:
- 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;
- Wish to discuss medical care;
- Able to consent and having signed a consent form.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
CHU Amiens
Amiens, France
CHU Brest
Brest, France
CHU Caen
Caen, France
CHD Vendée
La Roche-sur-Yon, France
CHU Le Mans
Le Mans, France
CHU Limoges
Limoges, France
GHICL- Hôpital Saint Philibert
Lomme, France
HCL
Lyon, France
CHU Montpellier
Montpellier, France
CH Morlaix
Morlaix, France
CHU Nantes
Nantes, France
CHU Nice
Nice, France
AP-HP Cochin
Paris, France
AP-HP La pitié
Paris, France
AP-HP Lariboisière
Paris, France
AP-HP Saint-Antoine
Paris, France
CHIC Quimper
Quimper, France
CHU Reims
Reims, France
CHU Saint Etienne
Saint-Etienne, France
CHU Strasbourg
Strasbourg, France
CHU Tours
Tours, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain Saraux, Pr
CHU Brest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2024
First Posted
October 16, 2024
Study Start
October 17, 2025
Primary Completion (Estimated)
April 1, 2031
Study Completion (Estimated)
April 1, 2031
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning five years and ending fifteen years following the final study report completion
- 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.
All collected data that underlie results in a publication