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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)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06643845
Acronym
INCREDIBLE
Enrollment
1000
Registered
2024-10-16
Start date
2025-10-17
Completion date
2031-04-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Surgery, Arthroplasty, Total knee replacement

Brief 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.

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

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

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.2 yearsThe 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

MeasureTime frameDescription
Study the proportion of delayed surgery in the medical group2 yearsNumber of cumulated surgery (yes/no) by month in the medical group
Study the proportion of patients with severe events induced by surgery2 yearsNumber of severe events (Who classification) in the surgical group.
Analyze the impact of physical activity on change of body mass by arm in the randomized population.2 yearsPerform analyses of body mass on whole body densitometry
To compare analgesic use by arm.2 yearsAnalgesic use by class in milligram.
To compare the 0-2 years cost using the National Health Data System between the 2 groups.0-2 yearsCost in euro between 0-2
To compare the 2-5 cost using the National Health Data System between the 2 groups.2-5 yearsCost in euro between 2-5 years

Countries

France

Contacts

CONTACTAlain Saraux, Pr
alain.saraux@chu-brest.fr+33 2 98 34 72 70
PRINCIPAL_INVESTIGATORAlain Saraux, Pr

CHU Brest

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026