drugset / Trial / NCT04231357

Greater Trochanteric Pain Syndrome: Efficacy of Ultrasound Guided Platelet-rich Plasma vs Needle Tenotomy.

NCT04231357

Phase 3 Completed 81 enrolled Isabel Andia
RandomizedParallel-groupDouble-blindTreatment

Summary

Great trochanteric pain syndrome (GTPS) is a difficult problem to manage and results in significant patient morbidity. This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have an ultrasound (US)-guided injection of pure platelet-rich plasma (PRP) or needle tenotomy. Outcome data will be collected before the intervention, and at 3, 6, and 12 months after intervention. Main outcome measure: percent of patients that experience a reduction of 25% in hip outcome score (HOS) (responders) at 6 months after the intervention. Secondary outcome measures include percent of responders at three and twelve months, and pain reduction (VAS) at 3, 6, and 12 months. Adverse reactions or events will be recorded.

Timeline

Start
2019-12-04
Primary completion
2023-01-27
Completion
2023-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Platelet Rich Plasma Other / unclassified 3 ml Other

Indications