Can non-surgical, targeted multimodal care delay or avoid total knee replacement?
Official title: Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)
Run by University Hospital, Brest · NCT06643845 · Data updated 2026-11-12
This trial tests whether a comprehensive medical and lifestyle approach can delay or avoid knee replacement in adults with osteoarthritis who were advised to consider surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 21 sites (Amiens and 20 other locations) |
| Status | Recruiting |
| Started | October 17, 2025 |
| Main results expected | April 2031 |
| Study ends | April 2031 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT06643845 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-90 with femoro-tibial osteoarthritis and Kellgren grade ≥2, planned for knee replacement, who have not recently had a corticosteroid joint injection and meet specified pain and function criteria.
✕Probably not a fit
Patients unlikely to benefit include those with contraindications to surgery or medical care, inflammatory arthritis, or concurrent conditions that limit medical options.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study examines whether a structured, multimodal medical management plan can extend the time before knee replacement is needed in patients with femoro-tibial osteoarthritis. Participants who have been recommended for total knee replacement will receive a combination of medical, non-medical, and previously less-used treatments, with the goal of avoiding major surgery if possible. The trial will track pain, function, and treatment pathways to identify strategies that may reduce the need for arthroplasty. It is conducted across several French centers under the leadership of Hospital Brest, with eligibility focusing on adults up to age 90 and specific imaging and clinical criteria. The aim is to clarify what constitutes a complete medical treatment plan and to personalize care based on patient situation.
Why it matters
Potential benefit: If successful, patients may delay or avoid knee replacement and experience better symptom control with medical strategies.
How similar studies have gone: Previous research supports that comprehensive medical management can help reduce surgical needs in knee OA, though this exact multimodal approach is being tested anew.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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CHU Brest
Brest, France Recruiting -
CHIC Quimper
Quimper, France Recruiting -
CHU Amiens
Amiens, France Not yet recruiting -
CHU Caen
Caen, France Not yet recruiting -
CHD Vendée
La Roche-sur-Yon, France Not yet recruiting -
CHU Le Mans
Le Mans, France Not yet recruiting
Show 15 more locations
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CHU Limoges
Limoges, France Not yet recruiting -
GHICL- Hôpital Saint Philibert
Lomme, France Not yet recruiting -
Hcl
Lyon, France Not yet recruiting -
CHU Montpellier
Montpellier, France Not yet recruiting -
CH Morlaix
Morlaix, France Not yet recruiting -
CHU Nantes
Nantes, France Not yet recruiting -
CHU Nice
Nice, France Not yet recruiting -
AP-HP Cochin
Paris, France Not yet recruiting -
AP-HP La pitié
Paris, France Not yet recruiting -
AP-HP Lariboisière
Paris, France Not yet recruiting -
AP-HP Saint-Antoine
Paris, France Not yet recruiting -
CHU Reims
Reims, France Not yet recruiting -
CHU Saint Etienne
Saint-Etienne, France Not yet recruiting -
CHU Strasbourg
Strasbourg, France Not yet recruiting -
CHU Tours
Tours, France Not yet recruiting
Study contacts
- Principal investigator: Alain Saraux, Pr — CHU Brest
- Study coordinator: Alain Saraux, Pr
- Email: alain.saraux@chu-brest.fr
- Phone: +33 2 98 34 72 70
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.