Knee OsteoarthritisNCT03082430
GO PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care
A study testing autologous PRP. in people with Knee Osteoarthritis, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- autologous PRP.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2017to 30 Sep 2018
- 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 20 to 80 years
- Gonarthrosis diagnostic objectified by the criteria of the American College of Rheumatology
- Joint pain for more than 6 months
- Answer "moderate" to the question about pain walking on flat ground
- Answer "moderate" to the question about trouble walking on flat ground
- Osteoarthritis stage 2 or 3 on the scale of Kellgren Lawrence (objectified radiography) within 6 months previous inclusion
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- Axial deformation of less than or equal to 5 ° lower limbs
- Informed consent signed by the patient
- HB> 10g / dl
- Beta-HCG negative at baseline
- Ability to perform the procedures in the follow-up (50 not walk on a flat surface and up / down stairs).
- Being affiliated to a system of health insurance
Who cannot join
- Axial deformation > 5 °
- Ligamentous instability
- Significant injuries or target knee or knee surgery contralateral side in 12 months previous the inclusion visit
- Ligament reconstruction in the 12 months précédants the inclusion visit
- Need a cane or assistance to move
- BMI> 35
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- Thrombocytopenia <150 G / L
- Thrombocytosis> 450 G / L
- Known thrombopathy
- Anemia HB <10g / dl
- Active infections to HIV 1 and 2, Agp24, HCV Ab, Ag and HbS AcHbc, Ac HTLV I and II, TPHA
- Chronic treatment with corticosteroids per os or older than 2 weeks
- Injection intra-articular corticosteroid of less than 2 months
- Intra-articular injection of hyaluronic acid of less than 6 months
- NSAIDs or antiplatelet agent of less than 15 days
- Inability to stop NSAIDs (including aspirin) 15 days before the injection and the week following the injection
- Fever or recent illness
- Autoimmune diseases
- Inflammatory arthritis
- Immune deficiency
- Infectious diseases
- Pregnant women
- Adults legally protected (under guardianship and trusteeship)
- People simultaneously participating in other biomedical research16. Inability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care
This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation
Read the detailed description
The main objective is to get a 50% proportion of responders defined by answers "absent" or "light" in the KOOS questionnaire on questions about pain and difficulty walking on flat ground.
Secondary objectives include the safety validation of the use of PRP (prepared standardized manner by means of a given medical device) as second-line standard of care for osteoarthritis by the introduction of a systematic monitoring; and the feasibility of the health care system dedicated to the treatment of knee osteoarthritis by autologous PRP.
Furthermore, the secondary objectives are to monitor and follow the evolution of pain (VAS) and the knee function (KOOS score) at 1 month, 3 months, 6 months. Evaluation of MRI will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
- Conditions
- Knee Osteoarthritis
- Being tested
- autologous PRP.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous PRP.Biological
one autologous PRP patient in this study and monitor and follow the evolution of pain and the knee function
| Study group | Role | What they receive |
|---|---|---|
| knee osteoarthritis patients. | Other | therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation. Receives: Biological: autologous PRP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to monitor and follow the evolution of pain
VAS to monitor and follow the evolution of pain
Measured: prior,1 month, 3 months, 6 months
to monitor and follow the evolution of the knee function
(KOOS score)
Measured: prior,1 month, 3 months, 6 months
Evaluation of MRI
Evaluation will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
Measured: prior,1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start19 Jan 2017
- Primary completion28 Feb 2018
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- descriptive study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Arniaud, Hospital St. Joseph, Marseille, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082430
- Sponsor's protocol ID
- GO PRP
- Status last verified
- May 2018
- First submitted
- 6 Mar 2017
- Last updated
- 4 May 2018
- 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 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study GO-PRP: Assessing the Efficacy of Intra Articular Injection of Platelets Rich Plasma for Gonarthrosis Treatment in Routine Care
- ClinicalTrials.gov ID
- NCT03082430
- Acronym / sponsor ID
- GO PRP
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 17 Mar 2017 (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.
This monocentric protocol is designed to evaluate the efficacy of therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation
Detailed description
The main objective is to get a 50% proportion of responders defined by answers "absent" or "light" in the KOOS questionnaire on questions about pain and difficulty walking on flat ground.
Secondary objectives include the safety validation of the use of PRP (prepared standardized manner by means of a given medical device) as second-line standard of care for osteoarthritis by the introduction of a systematic monitoring; and the feasibility of the health care system dedicated to the treatment of knee osteoarthritis by autologous PRP.
Furthermore, the secondary objectives are to monitor and follow the evolution of pain (VAS) and the knee function (KOOS score) at 1 month, 3 months, 6 months. Evaluation of MRI will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- descriptive study
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis patients. | Other | Biological: autologous PRP.therapeutic management of symptomatic knee osteoarthritis (resistant to medical first-line treatment) by intra-articular injection of autologous PRP prepared in the same procedure and using a dedicated CE marked medical device and a validated and reproducible method of preparation. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men and women 20 to 80 years
- Gonarthrosis diagnostic objectified by the criteria of the American College of Rheumatology
- Joint pain for more than 6 months
- Answer "moderate" to the question about pain walking on flat ground
- Answer "moderate" to the question about trouble walking on flat ground
Key exclusion criteria (24 listed)
- Axial deformation > 5 °
- Ligamentous instability
- Significant injuries or target knee or knee surgery contralateral side in 12 months previous the inclusion visit
- Ligament reconstruction in the 12 months précédants 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 |
|---|---|---|
| autologous PRP.one autologous PRP patient in this study and monitor and follow the evolution of pain and the knee function | Biological | knee osteoarthritis patients. |
Primary outcome
to monitor and follow the evolution of pain
Time frame: prior,1 month, 3 months, 6 months
VAS to monitor and follow the evolution of pain
to monitor and follow the evolution of the knee function
Time frame: prior,1 month, 3 months, 6 months
(KOOS score)
Evaluation of MRI
Time frame: prior,1 month, 3 months, 6 months
Evaluation will be performed within 15 days prior (inclusion visit) injection and 6 months to assess the cartilage thickness and visualize a regenerative effect.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- 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?
A study testing autologous PRP. in people with Knee Osteoarthritis, run by Hospital St. Joseph, Marseille, France 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 12 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 4 May 2018. 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?
Results are not available in the source record.
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?
to monitor and follow the evolution of pain (time frame: prior,1 month, 3 months, 6 months). The study lists 3 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 4 May 2018.