Clinical trial Recruiting at 2 sites Interventional Ages 18 to 90

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 typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment1000 (estimated)
SponsorUniversity Hospital, Brest
Academic / other
Locations21 sites (Amiens and 20 other locations)
StatusRecruiting
StartedOctober 17, 2025
Main results expectedApril 2031
Study endsApril 2031
Registry record updatedMay 22, 2026
Trial IDNCT06643845 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.