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

NCT ID: NCT02978833

Last Updated: 2018-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-01

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Tendinopathy Hip Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PRP

Group Type EXPERIMENTAL

PRP

Intervention Type BIOLOGICAL

Ultrasound

Intervention Type DEVICE

Whole Blood

Group Type ACTIVE_COMPARATOR

Whole Blood

Intervention Type BIOLOGICAL

Interventions

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PRP

Intervention Type BIOLOGICAL

Whole Blood

Intervention Type BIOLOGICAL

Ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Moley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-184

Identifier Type: -

Identifier Source: org_study_id

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