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NCT Number: NCT06643845

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroplasty

Procedure

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

Medical and non-medical treatments

Other

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 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.

    Time frame: 2 years

    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 &gt; 40/100 at 2 years.

Secondary outcomes

  1. Study the proportion of delayed surgery in the medical group

    Time frame: 2 years

    Number of cumulated surgery (yes/no) by month in the medical group

  2. Study the proportion of patients with severe events induced by surgery

    Time frame: 2 years

    Number of severe events (Who classification) in the surgical group.

  3. Analyze the impact of physical activity on change of body mass by arm in the randomized population.

    Time frame: 2 years

    Perform analyses of body mass on whole body densitometry

  4. To compare analgesic use by arm.

    Time frame: 2 years

    Analgesic use by class in milligram.

  5. To compare the 0-2 years cost using the National Health Data System between the 2 groups.

    Time frame: 0-2 years

    Cost in euro between 0-2

  6. To compare the 2-5 cost using the National Health Data System between the 2 groups.

    Time frame: 2-5 years

    Cost in euro between 2-5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Alain Saraux, Pr

CONTACT

[email protected]

+33 2 98 34 72 70

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: INCREDIBLE

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Oct 16, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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