Knee Pain ChronicEPROGENCT06466330
Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
A study testing microparticles and embolization in people with Knee Pain Chronic and Knee Pain Swelling, run by Societe Francaise de Rhumatologie at 11 sites in France.
Trial summary
The goal of this clinical investigation is to evaluate the effectiveness on pain of arterial occlusion (embolization) of neovessels by microparticle in a double-blind sham controlled randomised trial in patients with persistent pain on a total knee prosthesis (TKP), inserted for gonarthrosis, despite well-conducted… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Pain Chronic, Knee Pain Swelling
- What is being tested?
- microparticles and embolization
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 11 sitesFrance
- Study dates
- 10 Mar 2025to 28 Feb 2027
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged between 40 and 80 years with a TKR for more than one year.
- TKR pain with a VAS ≥ 40 mm having progressed for at least 3 months despite the initiation of a well-conducted medical treatment including stage I and II analgesics and NSAIDs in the absence of contraindication.
- Investigations within 6 months to rule out malposition, loosening and sepsis (conventional X-rays, bone scan, knee CT scan and biological work-up for inflammatory syndrome).
- No revision surgery envisaged.
- Echodoppler hyperemia over the painful area of the knee.
- Subjects affiliated to social security.
- Signed consent to the study.
Who cannot join
- Local infection of the TKR or systemic infection.
- Algoneurodystrophy.
- Prosthesis loosening.
- Neuropathic pain.
- Allergy to contrast media.
- Fibromyalgia.
Show all 13Show fewer
- Chronic or acute renal failure (clearance < 30 ml/mn).
- Hemostasis disorders (platelet count < 50,000/mm3 or patient activated partial thromboplastin time (aPTT)/control aPTT>1.2 or prothrombin ratio < 50%).
- Operative indication for removal of the prosthesis retained
- Patient with severe obliterative arteriopathy of the lower limbs (Leriche et Fontaine stage 3).
- Lidocaine contraindication: known hypersensitivity to lidocaine hydrochloride, amide-bonded local anesthetics or any of the excipients; patients with recurrent porphyria.
- Vulnerable persons (minors, patients under guardianship or curatorship, deprived of liberty, under court protection, etc.).
- Pregnant patients: for patients of childbearing age, a pregnancy test will be performed during the screening visit.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
Centre Hospitalier Henri Mondor
Créteil
Florent Eymard, MD
- Recruiting
Centre Hospitalier Dijon
Dijon
Paul Ornetti, MD
- Recruiting
Centre Hospitalier Universitaire de Grenoble
Grenoble
Xavier Romand, MD
- Not yet recruiting
Centre Hospitalier Saint-Philibert
Lomme
Tristan Pascart, MD, 03 20 22 50 59, Pascart.Tristan@ghicl.net
- Not yet recruiting
Hôpital Saint Philibert
Lomme
Tristan Pascard, MD
- Not yet recruiting
CHU Marseille
Marseille
Thao Pham, MD
- Recruiting
Centre Hospitalier Universitaire de Nice
Nice
Christian Roux, MD
- Not yet recruiting
Centre Hospitalier de Nîmes
Nîmes
Cecile Gaujoux-Viala, MD, +33 4 666 83120, cecile.GAUJOUX.VIALA@chu-nimes.fr
- Not yet recruiting
Hôpital Lariboisière
Paris
Augustin Latourte, MD
- Not yet recruiting
Hôpital Saint-Antoine
Paris
Jérémie Sellam, MD
- Not yet recruiting
Hospices Civils de Strasbourg
Strasbourg
Jacques-Eric Gottenberg, MD
About this study
The goal of this clinical investigation is to evaluate the effectiveness on pain of arterial occlusion (embolization) of neovessels by microparticle in a double-blind sham controlled randomised trial in patients with persistent pain on a total knee prosthesis (TKP), inserted for gonarthrosis, despite well-conducted medical treatment. The study patient population will consist of up to 112 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or saline in the sham arm. The efficacy of embolization will be judged on the basis of the following criteria: improvement in pain, mobility, use of pain medication, adverse effects of embolization and duration of improvement.
After verification of eligibility criteria, patients with painful total knee prosthesis will be randomized to either the embolization group or the control group. Embolization will be performed using microparticles (Embozene® Microspheres 100 microns from Varian), for the treatment group. For the "sham " group, only diagnostic arteriography will be performed without injection of microparticles. Subjects will be followed up at 1, 3, 6 and 12 months.
Read the detailed description
Rational: One hundred thousand total knee replacements (TKRs) are fitted annually in France. Twenty percent of patients who have undergone a TKR have residual pain unrelated to a technical fault or loosening. This pain is a major handicap in everyday life, with no effective therapeutic solution. Arterial embolization for therapeutic purposes is rapidly gaining ground in a variety of pathologies. Its use in intractable synovitis and osteoarthritis appears particularly attractive. To date, no randomized controlled study has been conducted to assess the analgesic effects of arterial embolization in patients with symptomatic TKR. A study of 12 patients at the CHU de NICE showed good tolerance of the technique and a significant effect on the KOOS 12 pain score, which improved by 38% at 3 and 6 months. In view of the results of this study, and in this situation of therapeutic impasse, it seems appropriate to evaluate this technique in a randomized, controlled therapeutic trial, which could offer real therapeutic hope
The main objective this double-blind (patient and evaluator), randomized, prospective study is to evaluate the effectiveness of embolization on the pain of patients with persistent pain on a total knee prosthesis by double-blind comparison of two groups at 3-months: the first control group (sham) will include patients who will benefit from arteriography and an injection of saline in their neovessels. The second group, called treatment group, will consist of patients whose neovessels will be occluded by inert microparticles of 100 µm. The pain will be evaluated in both groups before and 3 months after embolisation. The objective is to show that the pain is significantly less important in the group of patients whose neovessels have been occluded with microparticles in comparison to the control group.
Secondary objectives are to evaluate the effectiveness of neovascular embolization on pain, symptoms and functional limitation, knee stiffness, physical activity, quality of life, use of analgesics and anti-inflammatories over the 12 month-follow-up period. The safety and the medico-economic impact will also be evaluated.
Study Population: 112 patients aged 40 to 80 years with a painful total prosthesis with a visual analogue scale (VAS) score greater than or equal to 40 mm for at least 3 months despite an optimal medical treatment, and investigations ruling out malpositioning, loosening and sepsis of the prosthesis,
Primary endpoint: modification of the pain item of the self-administered 12-item Knee injury and Osteoarthritis Outcome Score (KOOS-12) between baseline and 3 months.
Secondary evaluation criteria are KOOS-12, VAS (visual analogic scale), AMIQUAL (Quality of Life Scale) at baseline and then at 6 months; the use of analgesics and anti-inflammatories; adverse effects, medico-economic impact of embolization.
Expected benefits: This study should contribute to improving knowledge in the field of knee prostheses and, more generally, knee osteoarthritis and its management. More importantly, should the study prove conclusive, the results would enable us to extend the use of embolization treatment to all patients with chronic pain following knee prosthesis. At a societal level, health savings could be envisaged thanks to lower consumption of care and prolonged autonomy.
- Conditions
- Knee Pain Chronic, Knee Pain Swelling
- Being tested
- microparticles, embolization, sham embolization
- Keywords
- total hip replacement, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microparticlesDevice
inert microparticles
embolizationProcedure or surgery
Injection of inert microparticles in neovessels using a microcatheter
sham embolizationProcedure or surgery
injection of saline solution
| Study group | Role | What they receive |
|---|---|---|
| Embolization | Experimental | The genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiography. Through groin access and puncture of the femoral artery through a microcatheter, microspheres (Embozene) will be injected into this area. Receives: Device: microparticles; Procedure: embolization |
| Placebo | Sham comparator | In the control (sham) arm patients will undergo angiography but there will be injection of saline. Receives: Procedure: sham embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the pain assessed by Pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) at 3 months
The effectiveness of embolization will be determined by pain assessment using the pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) self-questionnaire (score 0-100). The evolution of this pain score between M0 and M3 will be calculated. KOOS 12 is a self-administered questionnaire that measures patients' perceptions of their knee health, symptoms and functionality. The KOOS-12 comprises 4 items relating to pain, 4 items relating to function (activities of daily living, sport and recreation) and 4 items relating to quality of life.
Measured: before intervention and at month 3
Secondary outcomes (8)
Evolution of pain throughout the patient's follow-up period assessed by KOOS 12 pain score
The evolution of pain will be measured here by the KOOS 12 pain score, as in the main objective. The KOOS 12 pain score will be collected at Month 0, Month 1, Month 3, Month 6 and Month 12.
Measured: From before intervention to Month 12.
Progression of patient's symptoms and functional limitations throughout the patient's follow-up period assessed by global KOOS score
The patient's symptoms and functional limitations will be assessed using the global KOOS 12 score (score from 0 to 100). The global KOOS 12 score will be collected at Month 0, Month 1, Month 3, Month 6 and Month 12.
Measured: From before intervention to Month 12.
Evolution of pain throughout the patient's follow-up period assessed by VAS (Visual Analog Score)
Pain will be measured using a VAS (Visual Analog Scale). The VAS will be graduated from 0 to 100 mm, with 0 = no pain and 100 = maximum pain perceived in the 48 hours preceding the consultation, as recommended by the OARSI in osteoarthritis on pain assessment.The pain VAS will be collected at Month 0, Month 1, Month 3, Month 6 and Month 12.
Measured: From before intervention to Month 12.
Evolution of Quality of Life throughout the patient's follow-up period, assessed by the AMIQUAL (Arthrose des Membres Inférieurs et QUAlité de vie) Score
Quality of life (QoL) will be measured using the AMIQUAL score. This score is a quality-of-life instrument specific to hip and knee osteoarthritis, capable of capturing patients' perception of their disease.It comprises 5 domains: physical activity (19 items), mental health (14 items), social support (4 items), social functioning (3 items) and pain (3 items), plus 3 items relating to family, sexuality and work. Each item is scored from 1-10, with lower scores reflecting better quality of life. QoL will be collected during patient follow-up at Month 0, Month 3 and Month 12.
Measured: From before intervention to Month 12
Analgesic and anti-inflammatory drugs consumption throughout the the patient's follow-up period
This consumption will be evaluated by the number of days with anti-inflammatory drugs and the number of days with analgesics during the follow-up from Month 0 to Month 6. This information will be collected by the patient in a notebook provided specifically for this purpose. Patients will simply be asked to record the days on which they took anti-inflammatory drugs and analgesics in relation to their knee pain.
Measured: From before intervention to Month 12
Incidence of Serious Adverse Events (safety) throughout the study
Adverse events will be recorded throughout the sudy. Safety will be assessed by incidence of Serious Adverse Events.
Measured: From consent signature to Month12
Medico-economic impact assessed by the incremental cost-effectiveness ratio throughout the study
The medico-economic impact is assessed by the incremental cost-effectiveness ratio in terms of cost per patient with at least a 50% reduction in the KOOS 12 pain score throughout the study.
Measured: From before intervention to Month 12
Medico-economic impact assessed by the incremental cost-utility ratio throughout the study
The medico-economic impact is assessed by the incremental cost-utility ratio in terms of cost per quality-adjusted life year (QALY) gained. The EQ-5D-5L (EuroQol questionnaire 5-Dimensions-5 Levels) comprises a descriptive system and a visual analog scale (VAS). The descriptive system comprises 5 items representing 5 dimensions (mobility, autonomy, daily activities, pain/grief and anxiety/depression) with five levels of health status (no problems, mild problems, moderate problems, severe problems and extreme problems/incapacity). For each of the 5 dimensions, the patient's response is converted into a number between 1 and 5. The 5 numbers obtained are then combined to produce a five-digit score describing the patient's state of health, which is then converted into a utility value (For France : utility value of between -0.53 (health worse than death) and 1 (best possible health). The VAS records the respondent's self-assessed state of health (scale 0 to 100)
Measured: From before intervention to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start10 Mar 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Societe Francaise de Rhumatologie
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, Euraxi Pharma
- Responsible party
- Sponsor
- Investigators
- Christian Roux, Pr, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466330
- Sponsor's protocol ID
- EPROGE
- Acronym
- EPROGE
- Status last verified
- May 2025
- First submitted
- 10 Jun 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Microparticle Geniculate Artery Embolization in Total Knee Prosthesis Patients With Pain Resistant to Medical Treatment. A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06466330
- Acronym / sponsor ID
- EPROGE / EPROGE
- Conditions
- Knee Pain Chronic, Knee Pain Swelling
- Keywords
- total hip replacement, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Societe Francaise de RhumatologieUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, Euraxi Pharma
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Jun 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.
The goal of this clinical investigation is to evaluate the effectiveness on pain of arterial occlusion (embolization) of neovessels by microparticle in a double-blind sham controlled randomised trial in patients with persistent pain on a total knee prosthesis (TKP), inserted for gonarthrosis, despite well-conducted medical treatment. The study patient population will consist of up to 112 subjects with knee pain for at least 3 months that is resistant to conservative treatment measures. Subjects will be treated with knee embolisation or saline in the sham arm. The efficacy of embolization will be judged on the basis of the following criteria: improvement in pain, mobility, use of pain medication, adverse effects of embolization and duration of improvement.
After verification of eligibility criteria, patients with painful total knee prosthesis will be randomized to either the embolization group or the control group. Embolization will be performed using microparticles (Embozene® Microspheres 100 microns from Varian), for the treatment group. For the "sham " group, only diagnostic arteriography will be performed without injection of microparticles. Subjects will be followed up at 1, 3, 6 and 12 months.
Detailed description
Rational: One hundred thousand total knee replacements (TKRs) are fitted annually in France. Twenty percent of patients who have undergone a TKR have residual pain unrelated to a technical fault or loosening. This pain is a major handicap in everyday life, with no effective therapeutic solution. Arterial embolization for therapeutic purposes is rapidly gaining ground in a variety of pathologies. Its use in intractable synovitis and osteoarthritis appears particularly attractive. To date, no randomized controlled study has been conducted to assess the analgesic effects of arterial embolization in patients with symptomatic TKR. A study of 12 patients at the CHU de NICE showed good tolerance of the technique and a significant effect on the KOOS 12 pain score, which improved by 38% at 3 and 6 months. In view of the results of this study, and in this situation of therapeutic impasse, it seems appropriate to evaluate this technique in a randomized, controlled therapeutic trial, which could offer real therapeutic hope
The main objective this double-blind (patient and evaluator), randomized, prospective study is to evaluate the effectiveness of embolization on the pain of patients with persistent pain on a total knee prosthesis by double-blind comparison of two groups at 3-months: the first control group (sham) will include patients who will benefit from arteriography and an injection of saline in their neovessels. The second group, called treatment group, will consist of patients whose neovessels will be occluded by inert microparticles of 100 µm. The pain will be evaluated in both groups before and 3 months after embolisation. The objective is to show that the pain is significantly less important in the group of patients whose neovessels have been occluded with microparticles in comparison to the control group.
Secondary objectives are to evaluate the effectiveness of neovascular embolization on pain, symptoms and functional limitation, knee stiffness, physical activity, quality of life, use of analgesics and anti-inflammatories over the 12 month-follow-up period. The safety and the medico-economic impact will also be evaluated.
Study Population: 112 patients aged 40 to 80 years with a painful total prosthesis with a visual analogue scale (VAS) score greater than or equal to 40 mm for at least 3 months despite an optimal medical treatment, and investigations ruling out malpositioning, loosening and sepsis of the prosthesis,
Primary endpoint: modification of the pain item of the self-administered 12-item Knee injury and Osteoarthritis Outcome Score (KOOS-12) between baseline and 3 months.
Secondary evaluation criteria are KOOS-12, VAS (visual analogic scale), AMIQUAL (Quality of Life Scale) at baseline and then at 6 months; the use of analgesics and anti-inflammatories; adverse effects, medico-economic impact of embolization.
Expected benefits: This study should contribute to improving knowledge in the field of knee prostheses and, more generally, knee osteoarthritis and its management. More importantly, should the study prove conclusive, the results would enable us to extend the use of embolization treatment to all patients with chronic pain following knee prosthesis. At a societal level, health savings could be envisaged thanks to lower consumption of care and prolonged autonomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization | Experimental | Device: microparticles, Procedure: embolizationThe genicular artery embolisation procedure identifies abnormal blood vessels in the knee via angiography. Through groin access and puncture of the femoral artery through a microcatheter, microspheres (Embozene) will be injected into this area. |
| Placebo | Sham comparator | Procedure: sham embolizationIn the control (sham) arm patients will undergo angiography but there will be injection of saline. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or woman aged between 40 and 80 years with a TKR for more than one year.
- TKR pain with a VAS ≥ 40 mm having progressed for at least 3 months despite the initiation of a well-conducted medical treatment including stage I and II analgesics and NSAIDs in the absence of contraindication.
- Investigations within 6 months to rule out malposition, loosening and sepsis (conventional X-rays, bone scan, knee CT scan and biological work-up for inflammatory syndrome).
- No revision surgery envisaged.
- Echodoppler hyperemia over the painful area of the knee.
Key exclusion criteria (13 listed)
- Local infection of the TKR or systemic infection.
- Algoneurodystrophy.
- Prosthesis loosening.
- Neuropathic pain.
- Allergy to contrast media.
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 |
|---|---|---|
| microparticlesinert microparticles | Device | Embolization |
| embolizationInjection of inert microparticles in neovessels using a microcatheter | Procedure or surgery | Embolization |
| sham embolizationinjection of saline solution | Procedure or surgery | Placebo |
Primary outcome
Evolution of the pain assessed by Pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) at 3 months
Time frame: before intervention and at month 3
The effectiveness of embolization will be determined by pain assessment using the pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) self-questionnaire (score 0-100). The evolution of this pain score between M0 and M3 will be calculated. KOOS 12 is a self-administered questionnaire that measures patients' perceptions of their knee health, symptoms and functionality. The KOOS-12 comprises 4 items relating to pain, 4 items relating to function (activities of daily living, sport and recreation) and 4 items relating to quality of life.
8 secondary outcomes
Evolution of pain throughout the patient's follow-up period assessed by KOOS 12 pain score
Time frame: From before intervention to Month 12.
Progression of patient's symptoms and functional limitations throughout the patient's follow-up period assessed by global KOOS score
Time frame: From before intervention to Month 12.
Evolution of pain throughout the patient's follow-up period assessed by VAS (Visual Analog Score)
Time frame: From before intervention to Month 12.
Evolution of Quality of Life throughout the patient's follow-up period, assessed by the AMIQUAL (Arthrose des Membres Inférieurs et QUAlité de vie) Score
Time frame: From before intervention to Month 12
Analgesic and anti-inflammatory drugs consumption throughout the the patient's follow-up period
Time frame: From before intervention to Month 12
Incidence of Serious Adverse Events (safety) throughout the study
Time frame: From consent signature to Month12
Medico-economic impact assessed by the incremental cost-effectiveness ratio throughout the study
Time frame: From before intervention to Month 12
Medico-economic impact assessed by the incremental cost-utility ratio throughout the study
Time frame: From before intervention to Month 12
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 30 May 2025.
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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.
Christian Roux, Pr, MD principal investigator
Centre Hospitalier Universitaire de Nice
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microparticles and embolization in people with Knee Pain Chronic and Knee Pain Swelling, run by Societe Francaise de Rhumatologie at 11 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 13 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 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. Some participants in this study may receive a placebo. 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 Pascale Thevenot (+33(0)1.42.50.00.18, recherche@rhumatologie.asso.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the pain assessed by Pain item of the Knee injury and Osteoarthritis Outcome Score 12 (KOOS 12) at 3 months (time frame: before intervention and at month 3). 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 30 May 2025.