Osteoarthritis, KneePhase 1ECHOGUIDENCT05235854
Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.
A Phase 1 study testing Injection of corticosteroids (Diprostène®) in people with Osteoarthritis, Knee, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Injection of corticosteroids (Diprostène®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2022to 4 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).
- Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.
- Patient who has given free and informed consent.
- Patient who has signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
- Adult patient (≥18 years of age).
Who cannot join
- No iconographic evidence of meniscal injury.
- Associated lesions of the central pivot of the knee.
- Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).
- Presence of a skin lesion at the infiltration sites.
- Suspected soft tissue or joint infection.
- Patient participating in research involving human subjects defined as Category 1.
Show all 11Show fewer
- Patient in an exclusion period as determined by another study.
- Patient under court protection, guardianship or trusteeship.
- Patient unable to give consent.
- Patient for whom it is impossible to give informed information.
- Pregnant, parturient or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.
The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.
The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Injection of corticosteroids (Diprostène®)
- Keywords
- knee,, osteoarthritis,, meniscus,, Lysholm score,, corticoids, infiltration
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of corticosteroids (Diprostène®)Drug
Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.
| Study group | Role | What they receive |
|---|---|---|
| Meniscal wall infiltration group | Active comparator | Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control. Receives: Drug: Injection of corticosteroids (Diprostène®) |
| Intra-articular infiltration group | Active comparator | The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly.
Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe. Receives: Drug: Injection of corticosteroids (Diprostène®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score before infiltration (intra-articular group)
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Measured: 15 days before infiltration
Lysholm score before infiltration (meniscal wall group)
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Measured: 15 days before infiltration
Lysholm score after infiltration (intra-articular group)
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Measured: 3 months after infiltration
Lysholm score after infiltration (meniscal wall group)
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Measured: 3 months after infiltration
Secondary outcomes (32)
Arthroscopy required within six months of infiltration: (intra-articular group)
Yes/No and, if so, the date of the arthroscopy will be recorded.
Measured: 6 months after infiltration
Arthroscopy required within six months of infiltration: (meniscal wall group)
Yes/No and, if so, the date of the arthroscopy will be recorded.
Measured: 6 months after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 15 days before infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 1 week after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 2 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 3 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 4 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 5 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 6 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 7 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 8 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 9 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 10 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 11 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 12 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 15 days before infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 1 week after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 2 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 3 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 4 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 5 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 6 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 7 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 8 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 9 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 10 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 11 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Measured: 12 weeks after infiltration
Return to physical activity (intra-articular infiltration group)
The number of days taken for the patient to return to physical activity
Measured: Day 0 to Month 6
Return to physical activity (meniscal wall infiltration group)
The number of days taken for the patient to return to physical activity
Measured: Day 0 to Month 6
Adverse events in the intra-articular infiltration group
Collection of all possible adverse events from D0 to M3. Qualitative
Measured: Day 0 to 3 months after infiltration
Adverse events in the meniscal wall infiltration group
Collection of all possible adverse events from D0 to M3. Qualitative
Measured: Day 0 to 3 months after infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start12 May 2022
- Primary completion4 May 2026
- Study completion4 May 2026
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 Centre Hospitalier Universitaire de NīmesThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, double-blind, controlled study comparing two management strategies.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235854
- Sponsor's protocol ID
- NIMAO/2021-1/PM-01
- Acronym
- ECHOGUIDE
- Status last verified
- May 2026
- First submitted
- 21 Jan 2022
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.
- ClinicalTrials.gov ID
- NCT05235854
- Acronym / sponsor ID
- ECHOGUIDE / NIMAO/2021-1/PM-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee,, osteoarthritis,, meniscus,, Lysholm score,, corticoids, infiltration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 11 Feb 2022 (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 main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.
The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Single-center, randomized, double-blind, controlled study comparing two management strategies.
| Arm | Type | Receives |
|---|---|---|
| Meniscal wall infiltration group | Active comparator | Drug: Injection of corticosteroids (Diprostène®)Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control. |
| Intra-articular infiltration group | Active comparator | Drug: Injection of corticosteroids (Diprostène®)The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly. Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).
- Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.
- Patient who has given free and informed consent.
- Patient who has signed the consent form.
- Patient affiliated or beneficiary of a health insurance plan.
Key exclusion criteria (11 listed)
- No iconographic evidence of meniscal injury.
- Associated lesions of the central pivot of the knee.
- Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).
- Presence of a skin lesion at the infiltration sites.
- Suspected soft tissue or joint infection.
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 |
|---|---|---|
| Injection of corticosteroids (Diprostène®)Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe. | Drug | Intra-articular infiltration group, Meniscal wall infiltration group |
Primary outcome
Lysholm score before infiltration (intra-articular group)
Time frame: 15 days before infiltration
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score before infiltration (meniscal wall group)
Time frame: 15 days before infiltration
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score after infiltration (intra-articular group)
Time frame: 3 months after infiltration
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score after infiltration (meniscal wall group)
Time frame: 3 months after infiltration
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
32 secondary outcomes
Arthroscopy required within six months of infiltration: (intra-articular group)
Time frame: 6 months after infiltration
Arthroscopy required within six months of infiltration: (meniscal wall group)
Time frame: 6 months after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 15 days before infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 1 week after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 2 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 3 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 4 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 5 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 6 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 7 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 8 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 9 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 10 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 11 weeks after infiltration
Pain evaluated by the patient (intra-articular group)
Time frame: 12 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 15 days before infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 1 week after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 2 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 3 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 4 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 5 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 6 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 7 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 8 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 9 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 10 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 11 weeks after infiltration
Pain evaluated by the patient (meniscal wall group)
Time frame: 12 weeks after infiltration
Return to physical activity (intra-articular infiltration group)
Time frame: Day 0 to Month 6
Return to physical activity (meniscal wall infiltration group)
Time frame: Day 0 to Month 6
Adverse events in the intra-articular infiltration group
Time frame: Day 0 to 3 months after infiltration
Adverse events in the meniscal wall infiltration group
Time frame: Day 0 to 3 months after infiltration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Injection of corticosteroids (Diprostène®) in people with Osteoarthritis, Knee, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 13 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 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm score before infiltration (intra-articular group) (time frame: 15 days before infiltration). The study lists 4 primary outcomes in all. 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 13 May 2026.