RecruitingNot ApplicableNCT06643845

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

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


Sponsor

University Hospital, Brest

Enrollment

1,000 participants

Start Date

Oct 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

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Interventions

PROCEDUREarthroplasty

In the surgery arm, patients will have their surgery (arthroplasty), as originally planned.

OTHERMedical 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


Locations(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

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NCT06643845


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