Study Stopped
slow enrollment, lack of patients
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study
1 other identifier
interventional
2
1 country
1
Brief Summary
Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Oct 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 29, 2016
CompletedFirst Posted
Study publicly available on registry
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedAugust 7, 2018
August 1, 2018
3.7 years
November 29, 2016
June 4, 2018
August 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Improvement in Pain
The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
Up to 1 year post-injection
Improvement in Function
The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Up to 1 year post-injection
Patient Satisfaction
The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".
Up to 1 year post-injection
Secondary Outcomes (3)
Quality of Movement During the Forward Step-down Test
Up to 1 year post-injection
Pain During Side-lying Hip Abduction
Up to 1 year post-injection
Pain During Forward Step-down Test
Up to 1 year post-injection
Study Arms (2)
PRP
EXPERIMENTALWhole Blood
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Moderate to severe lateral hip pain for greater than 3 months
- Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition
- Moderate to severe gluteus medius tendinosis with or without partial tear \<1 cm
- Normal neurologic exam except for hip abductor weakness on the affected side
You may not qualify if:
- Severe (Tonnis grade \>1) hip osteoarthritis with active synovitis or bone edema
- Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution
- No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI
- Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions
- Non-English speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital for Special Surgery
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jennifer Cheng
- Organization
- Hospital for Special Surgery
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Moley, M.D.
Hospital for Special Surgery, New York
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2016
First Posted
December 1, 2016
Study Start
October 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 7, 2018
Results First Posted
August 7, 2018
Record last verified: 2018-08