Clinical trial NCT06643845: Can Multimodal Medical Strategies Can Delay 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Surgery
Arthroplasty
Total knee replacement
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Study the proportion of delayed surgery in the medical group
timeFrame: 2 years
measure: Study the proportion of patients with severe events induced by surgery
timeFrame: 2 years
measure: Analyze the impact of physical activity on change of body mass by arm in the randomized population.
timeFrame: 2 years
measure: To compare analgesic use by arm.
timeFrame: 2 years
measure: To compare the 0-2 years cost using the National Health Data System between the 2 groups.
timeFrame: 0-2 years
measure: To compare the 2-5 cost using the National Health Data System between the 2 groups.
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: CHU Le Mans
city: Limoges
country: France
facility: CHU Limoges
city: Lomme
country: France
facility: GHICL- Hôpital Saint Philibert
city: Lyon
country: France
facility: HCL
city: Montpellier
country: France
facility: CHU Montpellier
city: Morlaix
country: France
facility: CH Morlaix
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: AP-HP Cochin
city: Paris
country: France
facility: AP-HP La pitié
city: Paris
country: France
facility: AP-HP Lariboisière
city: Paris
country: France
facility: AP-HP Saint-Antoine
city: Quimper
country: France
facility: CHIC Quimper
city: Reims
country: France
facility: CHU Reims
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHU Brest
name: Alain Saraux, Pr
role: PRINCIPAL_INVESTIGATOR
References: