An observational study in Musculoskeletal Pain and Osteoarthritis, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by University of British Columbia · Observational
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.
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.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 40 is below the median of 163 across 136 observational studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adults have been selected to receive platelet-rich plasma (PRP) injections as a treatment for musculoskeletal or degenerative joint conditions
Exclusion Criteria:
Change in pre- and post- pain score at 3 and 6 weeks
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.
Time frame: Up to 6 weeks after injection
The impact of microparticle content on pain scores
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.
Time frame: Up to 6 weeks after injection
Correlation of platelet count to ThromboLUX results
Evaluation of PRP platelet count to clinical outcome and ThromboLUX data outputs
Time frame: Up to 6 weeks after injection
The use of dynamic light scattering (ThromboLUX) as a patient screening tool
To verify the performance of the ThromboLUX instrument in a clinical setting by reviewing size and composition of constituents in PRP
Time frame: Up to 6 weeks after injection
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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University of British Columbia