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

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status and phase

Terminated
Phase 4

Conditions

Hip Pain
Tendinopathy

Treatments

Device: Ultrasound
Biological: Whole Blood
Biological: PRP

Study type

Interventional

Funder types

Other

Identifiers

NCT02978833
2015-184

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

2 participants in 2 patient groups

PRP
Experimental group
Treatment:
Device: Ultrasound
Biological: PRP
Whole Blood
Active Comparator group
Treatment:
Biological: Whole Blood

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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