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Recruiting NCT06643845

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

No phase Interventional Osteoarthritis, Knee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: arthroplasty, Medical and non-medical treatments.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • Study the proportion of delayed surgery in the medical group [Time frame: 2 years]
  • Study the proportion of patients with severe events induced by surgery [Time frame: 2 years]
  • Analyze the impact of physical activity on change of body mass by arm in the randomized population. [Time frame: 2 years]
  • To compare analgesic use by arm. [Time frame: 2 years]
  • To compare the 0-2 years cost using the National Health Data System between the 2 groups. [Time frame: 0-2 years]
  • To compare the 2-5 cost using the National Health Data System between the 2 groups. [Time frame: 2-5 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 21 centers
  • CHU Amiens — Amiens
  • CHU Brest — Brest
  • CHU Caen — Caen
  • CHD Vendée — La Roche-sur-Yon
  • CHU Le Mans — Le Mans
  • CHU Limoges — Limoges
  • GHICL- Hôpital Saint Philibert — Lomme
  • HCL — Lyon
  • … and 13 more centers

Identifiers

NCT: NCT06643845 · 29BRC23.0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗