Performance-Enhancing Effects of Platelet-Rich Plasma (PRP) Injections

• ClinicalTrials.gov Identifier: NCT01200875
• Recruitment Status: Completed
• First Posted: September 14, 2010
• Results First Posted: December 6, 2016
• Last Update Posted: August 6, 2018
• Sponsor: Stanford University
• Collaborator: Partnership for Clean Competition
• Information provided by (Responsible Party): Jason L. Dragoo, Stanford University

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Conditions: Tendinopathy; Rheumatic Diseases
• Interventions: Procedure: Ultrasound-guided platelet-rich-plasma (PRP) injection; Procedure: Platelet-Rich Plasma (PRP)
• Enrollment: 25

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	PRP Injection (All Patients)
Arm/Group Description	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
Period Title: Overall Study
Started	25
Completed	25
Not Completed	0

Baseline Characteristics

Arm/Group Title		Treatment Arm
Arm/Group Description		All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
Overall Number of Baseline Participants		25
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants
		38.5 (11.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants
	Female	19 76.0%
	Male	6 24.0%
Region of Enrollment [1]; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	25 participants
		25
		[1] Measure Description: California, United States

Outcome Measures

1. Primary Outcome

Title	Blood Growth Factor Concentrations
Description	[Not Specified]
Time Frame	5 days following PRP injection

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRP Injection (All Patients)
Arm/Group Description:	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
Overall Number of Participants Analyzed	25
Mean (95% Confidence Interval); Unit of Measure: IGF-1 fold-change from baseline @ 24h
	1.078; (1.009 to 1.148)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Treatment Arm
Arm/Group Description	All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
All-Cause Mortality
	Treatment Arm
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Treatment Arm
	Affected / at Risk (%)
Total	0/25 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Treatment Arm
	Affected / at Risk (%)
Total	0/25 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jason Dragoo, Associate Professor
• Organization: Stanford University
• Phone: (650) 721-3430
• EMail: jdragoo@stanford.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wasterlain AS, Braun HJ, Harris AH, Kim HJ, Dragoo JL. The systemic effects of platelet-rich plasma injection. Am J Sports Med. 2013 Jan;41(1):186-93. doi: 10.1177/0363546512466383. Epub 2012 Dec 4.

• Responsible Party: Jason L. Dragoo, Stanford University
• ClinicalTrials.gov Identifier: NCT01200875
• Other Study ID Numbers: SU-08032010-6646; 18963 ( Other Identifier: Stanford IRB )
• First Submitted: September 2, 2010
• First Posted: September 14, 2010
• Results First Submitted: October 12, 2016
• Results First Posted: December 6, 2016
• Last Update Posted: August 6, 2018