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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal medical care arm | Experimental | In the medical care arm, rheumatologists will list previous treatment, ongoing treatment and then order validated treatment (corticosteroid or hyaluronic acid joint injection if necessary, physical activity and weight loss in the event of obesity, other non-drug treatments (insole, orthosis) as well as other drug treatments (pain killers or non steroidal anti-inflammatory drugs) including validated tools (personalized program, filmed sessions and digital exercise media for regular practice at home, motivational e-mails). At least one modification will be discussed in each domain (physical activity, weight loss, insole, orthosis, assistive device when walking, joint injection, pills -pain killer acetaminophen and opioids- nonsteroidal anti inflammatory drugs -with classical rules - and others) |
|
| Surgery arm | Active Comparator | In the surgery arm, patients will have to plan, as initially suggested, their surgery (total knee arthroplasty) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arthroplasty | Procedure | In the surgery arm, patients will have their surgery (arthroplasty), as originally planned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome relates to two scales which constitute the composite principal endpoint;
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Study the proportion of delayed surgery in the medical group | Number of cumulated surgery (yes/no) by month in the medical group | 2 years |
| Study the proportion of patients with severe events induced by surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Saraux, Pr | Contact | +33 2 98 34 72 70 | alain.saraux@chu-brest.fr |
| Name | Affiliation | Role |
|---|---|---|
| Alain Saraux, Pr | CHU Brest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Not yet recruiting | Amiens | France |
All collected data that underlie results in a publication
Data will be available beginning five years and ending fifteen years following the final study report completion
Data access request will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
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| 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 |
|
Number of severe events (Who classification) in the surgical group.
| 2 years |
| Analyze the impact of physical activity on change of body mass by arm in the randomized population. | Perform analyses of body mass on whole body densitometry | 2 years |
| To compare analgesic use by arm. | Analgesic use by class in milligram. | 2 years |
| To compare the 0-2 years cost using the National Health Data System between the 2 groups. | Cost in euro between 0-2 | 0-2 years |
| To compare the 2-5 cost using the National Health Data System between the 2 groups. | Cost in euro between 2-5 years | 2-5 years |
| CHU Brest | Recruiting | Brest | France |
|
| CHU Caen | Not yet recruiting | Caen | France |
|
| CHD Vendée | Not yet recruiting | La Roche-sur-Yon | France |
|
| CHU Le Mans | Not yet recruiting | Le Mans | France |
|
| CHU Limoges | Not yet recruiting | Limoges | France |
|
| GHICL- Hôpital Saint Philibert | Not yet recruiting | Lomme | France |
|
| HCL | Not yet recruiting | Lyon | France |
|
| CHU Montpellier | Not yet recruiting | Montpellier | France |
|
| CH Morlaix | Not yet recruiting | Morlaix | France |
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| CHU Nantes | Not yet recruiting | Nantes | France |
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| CHU Nice | Not yet recruiting | Nice | France |
|
| AP-HP Cochin | Not yet recruiting | Paris | France |
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| AP-HP La pitié | Not yet recruiting | Paris | France |
|
| AP-HP Lariboisière | Not yet recruiting | Paris | France |
|
| AP-HP Saint-Antoine | Not yet recruiting | Paris | France |
|
| CHIC Quimper | Recruiting | Quimper | France |
|
| CHU Reims | Not yet recruiting | Reims | France |
|
| CHU Saint Etienne | Not yet recruiting | Saint-Etienne | France |
|
| CHU Strasbourg | Not yet recruiting | Strasbourg | France |
|
| CHU Tours | Not yet recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001178 | Arthroplasty |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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