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A Comparison of PRP Treatment to the IA vs. IA and EA Environments in Patients Diagnosed With Hip Osteoarthritis

NCT04241354 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-09-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of one leukocyte-poor platelet-rich plasma (LP-PRP) injection to the intra-articular (IA) space in comparison to one LP-PRP injection to the IA space with an additional injection into the surrounding extra-articular (EA) structures for the treatment of hip OA (Kellgren Lawrence Grades 1-3). Our hypothesis is that patients receiving both IA and EA LP-PRP injections will have equivalent improvements on HOOS JR and VAS scores over a 12-month period compared to those in the active comparator group (IA LP-PRP injection).

Conditions

Interventions

BIOLOGICAL

Leukocyte-poor platelet rich plasma

Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation \[EmCyte Corp. Fort Myers FL\].

Sponsors & Collaborators

  • EmCyte Corporation

    collaborator INDUSTRY

  • Regenerative Orthopedics and Sports Medicine

    lead INDUSTRY

Principal Investigators

  • Sean W Mulvaney, MD · Regenerative Orthopedics and Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-25
Primary Completion
2021-12-01
Completion
2022-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241354 on ClinicalTrials.gov