Platelet-Rich Plasma (PRP) Injection for the Treatment of Chronic Patellar Tendinopathy (PRP)
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|ClinicalTrials.gov Identifier: NCT01843504|
Recruitment Status : Suspended (Due to COVID-19)
First Posted : April 30, 2013
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Patellar Tendinopathy Chronic PT||Biological: platelet rich plasma Other: saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Clinical, Biomechanical, and Tissue Regenerating Effects of a Single Platelet-rich Plasma Injection for the Treatment of Chronic Patellar Tendinopathy: a Randomized Controlled Trial|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Platelet Rich Plasma
Subjects in Group 1 (PRP) will receive a single US-guided injection of 5 mL autologous platelet-rich plasma at week 0 (baseline).
Biological: platelet rich plasma
A blood draw of 15 mL of the subject's own blood will be performed. The study coordinator will then place the sample in the Platelet Separator System (a centrifuge) and spin the blood sample in using a two-stage spinning: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets. This will be spun by centrifuge to yield 6 mL of concentrated autologous platelet. Under continuous ultrasound evaluation, 1.0-2.0 mL of the prepared PRP will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.
Placebo Comparator: Group 2
Subjects in Group 2 (saline control) will receive a single injection of 5 mL 0.9% normal saline at week 0.
A blood draw of 15 mL of the subject's own blood will be performed to maintain blinding. Under continuous ultrasound evaluation, 1.0-2.0 mL of the saline solution will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.
- Outcome questionnaire score evaluation [ Time Frame: One year ]Subjects will complete outcome questionnaires at weeks 0, 4, 8, 12, 16, and 32 weeks. The results will report evaluate improved pain- and function-dependent, knee-specific quality of life, as assessed by composite scores on the validated Victorian Institute of Sport Assessment-Patellar (VISAP), International Knee Documentation Committee (IKDC), and knee injection questionnaires. The results of the Groups 1 and 2 will be compared.
- Ultrasound evaluation of changes of pathologic features [ Time Frame: One year ]Ultrasound (US) changes of several pathologic features of PT will be evaluated using US imaging of the patellar tendon at 32 weeks compared to baseline imaging. Conventional ultrasound will be done to assess thickness (contralateral comparison), neovascularity, and hypoechogenicity; and Acoustoelastography (AE) will be done to measure stiffness changes of the patellar tendon using standardized 0-3 severity scales compared to control subjects.
- Evaluation of subject satisfaction of PRP therapy [ Time Frame: One year ]Outcome measures will be compared for satisfaction with PRP therapy as assessed by the treatment satisfaction survey score at 32 weeks post-treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843504
|United States, Wisconsin|
|Wisconsin Institute of Medical Research|
|Madison, Wisconsin, United States, 53705|
|UW Sports Medicine Clinic at Research Park|
|Madison, Wisconsin, United States, 53711|
|Principal Investigator:||John J. Wilson, MD, MS||UW-Madison School of Medicine & Public Health|
|Principal Investigator:||Stephen J. Almasi, MD||UW-Madison School of Medicine & Public Health|
|Principal Investigator:||Kenneth S. Lee, MD||UW-Madison School of Medicine & Public Health|