Meniscus LesionCOMPARENCT03966638
Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal Injection of Platelet-rich Plasma (PRP)
An observational study of Meniscus Lesion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Meniscal lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy. Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- Intra-meniscal injection of platelet-rich plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2017to 30 Nov 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patient with symptomatic non-surgical meniscal injury treated with percutaneous intravenous injection of platelet-rich plasma (PRP)
Who may be able to join
- isolated symptomatic meniscal lesion
- lesion confirmed by MRI
- grade II or III lesion touching the peripheral involvement of the middle segment,
- lesion treated by percutaneous intra meniscal PRP's injection
- IKDC score measured before injection and 6 months post-injection
Who cannot join
- other painful etiology of the knee
- emergency surgical management (luxation, bucket handle) or not (indication validated by the surgeon, meniscectomy or meniscal suture)
- impossibility to perform the procedure (non visible lesion, morphology of the patient, cutaneous infection, coagulation treatment in progress)
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Radiology, Croix-Rousse Hospital, Hospices Civils de Lyon
Lyon, 69004
About this study
Official title: Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal
Meniscal lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy.
Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions.
Read more
PRP has been injected under ultrasound in tendons or intra-articularly for several years.
This technique of meniscal percutaneous injection of PRP is now carried out for more than 2 years in our hospital, with satisfactory preliminary results, without any complication.
All patients in our study received an intra-meniscal injection of PRP, under echographic control. They were evaluated clinically and by Magnetic Resonance Imaging (MRI) before and at 6 months of the injection.
The aim of the study is to evaluate the efficacy of intra-meniscal injection of PRP on the symptomatology of the patients (pain, sport activities and daily life) at 6 months post-treatment.
- Conditions
- Meniscus Lesion
- Being tested
- Intra-meniscal injection of platelet-rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-meniscal injection of platelet-rich plasmaProcedure or surgery
Intra-meniscal injection of platelet-rich plasma under echographic control
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving platelet rich plasma | The group is composed of patients receiving an intra-meniscal injection of platelet-rich plasma, under echographic control, for isolated meniscal lesion. Receives: Procedure: Intra-meniscal injection of platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of International Knee Documentation Committee (IKDC) score
The variation of IKDC score between before injection and 6 months post-injection will be calculated. The IKDC score ranges from 0 to 100 and is interpreted as a measure of function with higher scores representing higher levels of function.
Measured: Between 0 and 6 months post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Nov 2017
- Primary completion30 Apr 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966638
- Sponsor's protocol ID
- CRC_GHN_2019_006
- Acronym
- COMPARE
- Status last verified
- Mar 2022
- First submitted
- 27 May 2019
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiological Evaluation of Meniscal Healing After Percutaneous Intra-meniscal
- ClinicalTrials.gov ID
- NCT03966638
- Acronym / sponsor ID
- COMPARE / CRC_GHN_2019_006
- Conditions
- Meniscus Lesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 29 May 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 lesions are a common pathology among athletes, and have an impact on the daily or sporting practice of patients. The consequences of surgical treatment are sometimes heavy.
Platelet-rich-plasma (PRP) has been shown to be effective in healing tendon and ligament lesions.
PRP has been injected under ultrasound in tendons or intra-articularly for several years.
This technique of meniscal percutaneous injection of PRP is now carried out for more than 2 years in our hospital, with satisfactory preliminary results, without any complication.
All patients in our study received an intra-meniscal injection of PRP, under echographic control. They were evaluated clinically and by Magnetic Resonance Imaging (MRI) before and at 6 months of the injection.
The aim of the study is to evaluate the efficacy of intra-meniscal injection of PRP on the symptomatology of the patients (pain, sport activities and daily life) at 6 months post-treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving platelet rich plasma | – | Procedure: Intra-meniscal injection of platelet-rich plasmaThe group is composed of patients receiving an intra-meniscal injection of platelet-rich plasma, under echographic control, for isolated meniscal lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with symptomatic non-surgical meniscal injury treated with percutaneous intravenous injection of platelet-rich plasma (PRP)
Key inclusion criteria (5 listed)
- isolated symptomatic meniscal lesion
- lesion confirmed by MRI
- grade II or III lesion touching the peripheral involvement of the middle segment,
- lesion treated by percutaneous intra meniscal PRP's injection
- IKDC score measured before injection and 6 months post-injection
Key exclusion criteria (3 listed)
- other painful etiology of the knee
- emergency surgical management (luxation, bucket handle) or not (indication validated by the surgeon, meniscectomy or meniscal suture)
- impossibility to perform the procedure (non visible lesion, morphology of the patient, cutaneous infection, coagulation treatment in progress)
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 |
|---|---|---|
| Intra-meniscal injection of platelet-rich plasmaIntra-meniscal injection of platelet-rich plasma under echographic control | Procedure or surgery | Patients receiving platelet rich plasma |
Primary outcome
Variation of International Knee Documentation Committee (IKDC) score
Time frame: Between 0 and 6 months post injection
The variation of IKDC score between before injection and 6 months post-injection will be calculated. The IKDC score ranges from 0 to 100 and is interpreted as a measure of function with higher scores representing higher levels of function.
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 21 Mar 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Meniscus Lesion, run by Hospices Civils de Lyon 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 5 inclusion and 3 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 21 Mar 2022. 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?
Variation of International Knee Documentation Committee (IKDC) score (time frame: Between 0 and 6 months post injection). 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 21 Mar 2022.