Osteoarthritis, KneeINCREDIBLENCT06643845
Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement?
A study testing arthroplasty and Medical and non-medical treatments in people with Osteoarthritis, Knee, run by University Hospital, Brest at 21 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- arthroplasty and Medical and non-medical treatments
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 21 sitesFrance
- Study dates
- 17 Oct 2025to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
France21 sites, 21 recruiting
- Not yet recruiting
CHU Amiens
Amiens
Vincent Goeb, Goeb.Vincent@chu-amiens.fr
- Recruiting
CHU Brest
Brest
Alain Saraux, Pr, alain.saraux@chu-brest.fr
- Not yet recruiting
CHU Caen
Caen
Anne Christine Rat, rat-ac@chu-caen.fr
- Not yet recruiting
CHD Vendée
La Roche-sur-Yon
Grégoire Cormier, Dr, gregoire.cormier@ght85.fr
- Not yet recruiting
CHU Le Mans
Le Mans
Emmanuelle Dernis, edernis@ch-lemans.fr
- Not yet recruiting
CHU Limoges
Limoges
Pascale Vergne-Salle
- Not yet recruiting
GHICL- Hôpital Saint Philibert
Lomme
Tristan Pascart, Pascart.tristan@ghicl.net
- Not yet recruiting
HCL
Lyon
Roland Chapurlat, roland.chapurlat@inserm.fr
- Not yet recruiting
CHU Montpellier
Montpellier
Pers Yves Marie, ym-pers@chu-montpellier.fr
Claire Daien, c-daien@chu-montpellier.fr
- Not yet recruiting
CH Morlaix
Morlaix
Catherine Le Henaff, lehenaff-rhumato@wanadoo.fr
- Not yet recruiting
CHU Nantes
Nantes
Benoit Le Goff, benoit.legoff@chu-nantes.fr
- Not yet recruiting
CHU Nice
Nice
Christian Roux, roux.c2@chu-nice.fr
- Not yet recruiting
AP-HP Cochin
Paris
François Rannou, francois.rannou@aphp.fr
- Not yet recruiting
AP-HP La pitié
Paris
Bruno Fautrel, bruno.fautrel@aphp.fr
- Not yet recruiting
AP-HP Lariboisière
Paris
Pascal Richette, pascal.richette@aphp.fr
- Not yet recruiting
AP-HP Saint-Antoine
Paris
Jérémie Sellam, jeremie.sellam@aphp.fr
- Recruiting
CHIC Quimper
Quimper
Elise DOARE, elise.doare@ch-cornouaille.fr
- Not yet recruiting
CHU Reims
Reims
Jean-Hugues Salmon, jhsalmon@chu-reims.fr
- Not yet recruiting
CHU Saint Etienne
Saint-Etienne
Thierry Thomas, thierry.thomas@chu-st-etienne.fr
- Not yet recruiting
CHU Strasbourg
Strasbourg
Gottenberg Eric, jacques-eric.gottenberg@chru-strasbourg.fr
- Not yet recruiting
CHU Tours
Tours
Philippe Goupille, philippe.goupille@univ-tours.fr
About this study
Official title: Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- arthroplasty, Medical and non-medical treatments
- Keywords
- Surgery, Arthroplasty, Total knee replacement
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arthroplastyProcedure or surgery
In the surgery arm, patients will have their surgery (arthroplasty), as originally planned.
Medical and non-medical treatmentsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Medical and non-medical treatments |
| Surgery arm | Active comparator | In the surgery arm, patients will have to plan, as initially suggested, their surgery (total knee arthroplasty) Receives: Procedure: arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
Study the proportion of delayed surgery in the medical group
Number of cumulated surgery (yes/no) by month in the medical group
Measured: 2 years
Study the proportion of patients with severe events induced by surgery
Number of severe events (Who classification) in the surgical group.
Measured: 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
Measured: 2 years
To compare analgesic use by arm.
Analgesic use by class in milligram.
Measured: 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
Measured: 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
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start17 Oct 2025
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Saraux, Pr, Principal investigator, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643845
- Sponsor's protocol ID
- 29BRC23.0002
- Acronym
- INCREDIBLE
- Status last verified
- May 2026
- First submitted
- 19 Aug 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Non Surgical CaRE Using Treat to Target Multimodal meDIcal Strategies aBLE to Delay or Avoid Total Knee Replacement? (INCREDIBLE)
- ClinicalTrials.gov ID
- NCT06643845
- Acronym / sponsor ID
- INCREDIBLE / 29BRC23.0002
- Conditions
- Osteoarthritis, Knee
- Keywords
- Surgery, Arthroplasty, Total knee replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal medical care arm | Experimental | Other: Medical and non-medical treatmentsIn 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 | Procedure: arthroplastyIn the surgery arm, patients will have to plan, as initially suggested, their surgery (total knee arthroplasty) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arthroplastyIn the surgery arm, patients will have their surgery (arthroplasty), as originally planned. | Procedure or surgery | Surgery arm |
| Medical and non-medical treatmentsIn 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 | Other | Multimodal medical care arm |
Primary outcome
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 \> 40/100 at 2 years.
6 secondary outcomes
Study the proportion of delayed surgery in the medical group
Time frame: 2 years
Study the proportion of patients with severe events induced by surgery
Time frame: 2 years
Analyze the impact of physical activity on change of body mass by arm in the randomized population.
Time frame: 2 years
To compare analgesic use by arm.
Time frame: 2 years
To compare the 0-2 years cost using the National Health Data System between the 2 groups.
Time frame: 0-2 years
To compare the 2-5 cost using the National Health Data System between the 2 groups.
Time frame: 2-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alain Saraux, Pr principal investigator
CHU Brest
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arthroplasty and Medical and non-medical treatments in people with Osteoarthritis, Knee, run by University Hospital, Brest at 21 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Saraux, Pr (+33 2 98 34 72 70, alain.saraux@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.