- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726464
Testing the Characteristics of Platelet Rich Plasma in Sports Medicine (PRiSM)
This is an observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal injuries and degenerative joint diseases.
A sample of the PRP will be tested for platelet and microparticle content using dynamic light scattering to determine if there is a relationship between the composition and the treatment outcome.
Study Overview
Status
Conditions
Detailed Description
An observational study that evaluates the characteristics of Platelet Rich Plasma used in the therapy and treatment of musculoskeletal and degenerative joint conditions.
Patients enrolled in this study have already been assessed by the Principal Investigator and are schedule to receive treatment with Platelet Rich Plasma. Prior to the treatment patients will be asked to consent in the study where the composition of the PRP is to be evaluated. Consenting patients that meet inclusion/exclusion criteria will complete a pain score self-assessment prior to treatment.
An autologous preparation of PRP sample will be made from the subject's whole blood. The subject will receive the PRP treatment and an excess portion of the PRP preparation will be tested for composition and the relative concentration of the constituents.
The sample of the PRP will be tested using Dynamic Light Scattering (ThromboLUX System) to measure the constituents in PRP preparations prior to injection. PRP and whole blood (at physician's discretion) will be analyzed on a hematology analyzer.
The testing work-flow does not alter the subject's standard of care. The physician will be blinded to the analytical results during the enrolment, treatment and patient follow-up phase of the study. Analytical results are not used in patient management decisions.
Patient's response to the PRP treatment will be assessed at 3 and 6 weeks post injection. At these times, the clinical outcome of the treatment will be measured using a patient self -assessment (post-treatment pain scores).
This study will test the hypothesis that PRP characteristics, such as platelet and microparticle content and composition can be predictive clinical outcome for PRP treatments.
The clinical outcome will be evaluated by patient pre- and post-pain score assessment. This study aims to review clinical outcomes and compare these results against ThromboLUX and other test results. If the predictive value of platelet composition testing can be demonstrated, additional studies may be considered.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6T1Z3
- Allan McGavin Sports Medicine Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Are willing and able to give informed consent for participation in the study
- Have a diagnosed injury/condition requiring PRP injection: patients with acute or chronic musculoskeletal injury, tendinopathy, or mild to moderate osteoarthritis of the knee
- Are otherwise healthy
- Agree to pre-treatment fasting (4 hours prior to treatment)
- Agree to disclose medications taken in the last 2 weeks
- Able (in the Investigators opinion) and willing to comply with all study requirements
- Able to attend an on-site visit or provide information on your current status electronically, 3 and 6 weeks following the PRP injection
- Have not previously received a PRP injection for your current injury
Exclusion Criteria:
- Unable to provide informed consent
- Have any blood borne disease, currently or in the past
- Have a systemic inflammatory disease, skin or joint infection, bleeding disorders, or compromised immune function
- Have a known platelet abnormality or hematological disorder
- Are not able or willing to share with the study team any medications taken in the last two weeks.
- Taking anti-inflammatory medications or medications that interfere with clotting
- Are female and are pregnant or breast feeding
- Have inadequate venous access for drawing blood
- Have any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the patients ability to participate in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pre- and post- pain score at 3 and 6 weeks
Time Frame: Up to 6 weeks after injection
|
The primary objective of the study is to test the hypothesis that the constituents in platelet-rich plasma (PRP) preparations, such as platelet and microparticle content and composition, can be correlated to the clinical outcome for PRP treatments.
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Up to 6 weeks after injection
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The impact of microparticle content on pain scores
Time Frame: Up to 6 weeks after injection
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The study will ascertain the capability of ThromboLUX microparticle assay results to correlate with the clinical outcome for PRP treatments when evaluated by patient pre- and post-pain score assessment.
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Up to 6 weeks after injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of platelet count to ThromboLUX results
Time Frame: Up to 6 weeks after injection
|
Evaluation of PRP platelet count to clinical outcome and ThromboLUX data outputs
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Up to 6 weeks after injection
|
The use of dynamic light scattering (ThromboLUX) as a patient screening tool
Time Frame: Up to 6 weeks after injection
|
To verify the performance of the ThromboLUX instrument in a clinical setting by reviewing size and composition of constituents in PRP
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Up to 6 weeks after injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Don McKenzie, MD, PhD, LLD, University of British Columbia
- Study Director: Jennifer Leung, MSc, LightIntegra Technology Inc
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H16-00328
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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