Trial Outcomes & Findings for Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy (NCT NCT02978833)

NCT ID: NCT02978833

Last Updated: 2018-08-07

Results Overview

The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Up to 1 year post-injection

Results posted on

2018-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Platelet-rich Plasma PRP Ultrasound	Whole Blood Whole Blood
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Platelet-rich Plasma PRP Ultrasound	Whole Blood Whole Blood
Overall Study Study terminated	1	1

Baseline Characteristics

Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platelet-rich Plasma n=1 Participants PRP Ultrasound	Whole Blood n=1 Participants Whole Blood	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year post-injection

Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.

The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 1 year post-injection

Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.

The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 1 year post-injection

Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.

The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year post-injection

Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.

The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year post-injection

Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.

Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 1 year post-injection

Population: This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.

Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".

Outcome measures

Outcome data not reported

Adverse Events

Platelet-rich Plasma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Whole Blood

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Cheng

Hospital for Special Surgery

Phone: 6467146870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place