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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity Hospital, Brest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • arthroplasty

    Procedure/Surgery

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

  • Medical and non-medical treatments

    Other intervention

    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

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Multimodal medical care armExperimental treatment 1 intervention
Group B: Surgery armActive comparator 1 intervention

Trial outcomes

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.

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 \> 40/100 at 2 years.

Time frame
2 years

Secondary outcomes

1

Study the proportion of delayed surgery in the medical group

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

Time frame
2 years
2

Study the proportion of patients with severe events induced by surgery

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

Time frame
2 years
3

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

Time frame
2 years
4

To compare analgesic use by arm.

Analgesic use by class in milligram.

Time frame
2 years

Other outcomes

Sponsors and contacts

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