DEGENERATIVE MENISCAL LESIONSMENIPREPNCT03866824
MENIPREP Study: Evauation of the Effectiveness of Prp Injection in the Management of Degenerative Meniscal Lesions : Randomized Controlled Trial Double Blind Versus Reference Treatment"
A study testing injection of Platelet Enhanced Plasma(PRP), injection of corticosteroids and RMI in people with DEGENERATIVE MENISCAL LESIONS, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Meniscal tissue has very limited intrinsic properties in terms of repair, given the low mitotic activity of chondrocytes and poor vascularization. Nevertheless, its capacity for regeneration, in vivo and in vitro, can be stimulated by the contribution of growth factors, as has been widely described in the medical and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- DEGENERATIVE MENISCAL LESIONS
- What is being tested?
- injection of Platelet Enhanced Plasma(PRP), injection of corticosteroids and RMI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 4 Dec 2023
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 20 to 80
- MDD diagnosis objected to MRI (grade II/III)
- Joint pain for more than 3 month
- Absence of bone lesion or moderate knee osteoarthritis stage <2 on the Kellgren Laurence scale (objectified on radiography in schuss) in the 6 months prior to inclusion
- Axial deformity of the lower limbs less than or equal to 5 °
- Signed consent signed by the patient
- Ability to perform procedures as part of the follow-up (walk 50 steps on a flat surface and up / down stairs).
- Be affiliated to a health insurance scheme
Who cannot join
- Axial deformity> 5 °
- Ligament instability
- Major injuries or surgery of the target knee or lateral contralateral knee in the 12 months preceding the inclusion visit
- Ligament reconstruction in the 12 months prior to the inclusion visit
- Need a cane or assistance to move
- BMI> 35
- Thrombocytopenia <150 G / L
- Thrombocytosis> 450 G / L
Trial locations and contacts
1 site in 1 country.
About this study
Meniscal tissue has very limited intrinsic properties in terms of repair, given the low mitotic activity of chondrocytes and poor vascularization. Nevertheless, its capacity for regeneration, in vivo and in vitro, can be stimulated by the contribution of growth factors, as has been widely described in the medical and scientific literature. Platelet Enhanced Plasma (PRP) is an autologous biological product (that is, derived from the patient's blood) containing a growth factor concentrate. The contribution of these growth factors stimulates cartilage repair by stimulating neovascularization, collagen synthesis and activation of chondrocytes. Intra-articular injection PRP is an autologous biological product, now used in daily practice for the treatment of early osteoarthritic lesions.
The hypothesis of this work is that the injection of PRP in contact with LMD(Degenerative Meniscal Lesions) will improve the clinical symptomatology of our patients compared to reference treatment (intra-auricular injection of corticosteroids).
- Conditions
- DEGENERATIVE MENISCAL LESIONS
- Being tested
- injection of Platelet Enhanced Plasma(PRP), injection of corticosteroids, RMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of Platelet Enhanced Plasma(PRP)Drug
intra-articular injection
injection of corticosteroidsDrug
intra-articular injection
RMIDevice
A CONTROL RMI at 1 year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Not described Receives: Drug: injection of Platelet Enhanced Plasma(PRP); Device: RMI |
| reference treatment | Active comparator | Not described Receives: Drug: injection of corticosteroids; Device: RMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control by Magnetic Resonance Imaging (MIR)
To evaluate the evolution of the LMD compared to pretherapeutic images.
Measured: 12 Months
Secondary outcomes (3)
self-completed questionnaire EVA score
EVA (analogical visual scale)
Measured: 12 Months
self-completed questionnaire SF36
SF36 (The Short Form (36) Health Survey)
Measured: 12 Months
self-completed questionnaire KOOS score
KOOS (Knee Injury and Osteoarthritis Outcome Score)
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Mar 2021
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DEGENERATIVE MENISCAL LESIONSStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-olivier ARNAUD, Study director, ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866824
- Sponsor's protocol ID
- 2018-55
- Other IDs
- 2018-A02497-48
- Acronym
- MENIPREP
- Status last verified
- Jun 2025
- First submitted
- 4 Mar 2019
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MENIPREP Study: Evauation of the Effectiveness of Prp Injection in the Management of Degenerative Meniscal Lesions : Randomized Controlled Trial Double Blind Versus Reference Treatment"
- ClinicalTrials.gov ID
- NCT03866824
- Acronym / sponsor ID
- MENIPREP / 2018-55
- Conditions
- DEGENERATIVE MENISCAL LESIONS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 7 Mar 2019 (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.
Meniscal tissue has very limited intrinsic properties in terms of repair, given the low mitotic activity of chondrocytes and poor vascularization. Nevertheless, its capacity for regeneration, in vivo and in vitro, can be stimulated by the contribution of growth factors, as has been widely described in the medical and scientific literature. Platelet Enhanced Plasma (PRP) is an autologous biological product (that is, derived from the patient's blood) containing a growth factor concentrate. The contribution of these growth factors stimulates cartilage repair by stimulating neovascularization, collagen synthesis and activation of chondrocytes. Intra-articular injection PRP is an autologous biological product, now used in daily practice for the treatment of early osteoarthritic lesions.
The hypothesis of this work is that the injection of PRP in contact with LMD(Degenerative Meniscal Lesions) will improve the clinical symptomatology of our patients compared to reference treatment (intra-auricular injection of corticosteroids).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Drug: injection of Platelet Enhanced Plasma(PRP), Device: RMI |
| reference treatment | Active comparator | Drug: injection of corticosteroids, Device: RMI |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women aged 20 to 80
- MDD diagnosis objected to MRI (grade II/III)
- Joint pain for more than 3 month
- Absence of bone lesion or moderate knee osteoarthritis stage <2 on the Kellgren Laurence scale (objectified on radiography in schuss) in the 6 months prior to inclusion
- Axial deformity of the lower limbs less than or equal to 5 °
Key exclusion criteria (8 listed)
- Axial deformity> 5 °
- Ligament instability
- Major injuries or surgery of the target knee or lateral contralateral knee in the 12 months preceding the inclusion visit
- Ligament reconstruction in the 12 months prior to the inclusion visit
- Need a cane or assistance to move
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 Platelet Enhanced Plasma(PRP)intra-articular injection | Drug | PRP group |
| injection of corticosteroidsintra-articular injection | Drug | reference treatment |
| RMIA CONTROL RMI at 1 year follow-up. | Device | PRP group, reference treatment |
Primary outcome
Control by Magnetic Resonance Imaging (MIR)
Time frame: 12 Months
To evaluate the evolution of the LMD compared to pretherapeutic images.
3 secondary outcomes
self-completed questionnaire EVA score
Time frame: 12 Months
self-completed questionnaire SF36
Time frame: 12 Months
self-completed questionnaire KOOS score
Time frame: 12 Months
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 29 Jun 2025.
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Meniscus Lesion
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.
jean-olivier ARNAUD study director
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of Platelet Enhanced Plasma(PRP), injection of corticosteroids and RMI in people with DEGENERATIVE MENISCAL LESIONS, run by Assistance Publique Hopitaux De Marseille 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 8 inclusion and 8 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 29 Jun 2025. 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.
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?
Control by Magnetic Resonance Imaging (MIR) (time frame: 12 Months). 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 29 Jun 2025.