Osteoarthritis Clinical Trial
Official title:
Testing the Characteristics of Platelet Rich Plasma in Sports Medicine
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.
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