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

Phase 4

Terminated

• Conditions: Tendinopathy; Hip Pain
• Interventions: Biological: PRP; Biological: Whole Blood; Device: Ultrasound

• Registration Number: NCT02978833
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-01
• Study First Submitted: 2016-11-29
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Results First Submitted: 2018-06-04
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-06
• Last Update Submitted: 2018-08-06
• Results First Posted: 2018-08-07
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRP	PRP	-
PRP	Ultrasound	-
Whole Blood	Whole Blood	-

Primary Outcome Measures

Name	Time	Method
Improvement in Pain	Up to 1 year post-injection	The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.
Improvement in Function	Up to 1 year post-injection	The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.
Patient Satisfaction	Up to 1 year post-injection	The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".

Secondary Outcome Measures

Name	Time	Method
Quality of Movement During the Forward Step-down Test	Up to 1 year post-injection	The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".
Pain During Side-lying Hip Abduction	Up to 1 year post-injection	Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".
Pain During Forward Step-down Test	Up to 1 year post-injection	Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States