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

Phase 1

• Conditions: Degeneration; Osteoarthritis, Hip; Osteoarthritis
• Interventions: Biological: Leukocyte-poor platelet rich plasma

• Registration Number: NCT04241354
• Lead Sponsor: Regenerative Orthopedics and Sports Medicine

Brief 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).

Detailed Description

A novel comprehensive approach through which the joint and its surrounding structures are treated as an integrated system may offer a clinically superior treatment to hip osteoarthritis (OA) compared to only an intra-articular (IA) infiltration. The efficacy of autologous leukocyte-poor platelet-rich plasma (LP-PRP) for the treatment of OA is a growing area of regenerative orthopedic research.

The purpose of this study is to determine if a LP-PRP treatment to both the IA space and EA supporting capsular ligament and tendon structures provides a significant clinical benefit when compared to an IA treatment alone. In this clinical study of 84 patients, both study arms receive effective treatments that are supported by sound medical evidence, making this an ethically strong model to address our hypothesis.

This is a multi-site, randomized, comparative study of LP-PRP treatment into the IA space versus the IA space and EA hip structures. This study is sponsored by Regenerative Orthopedics and Sports Medicine (ROSM) and EmCyte Corporation. Patients who meet the study criteria with at least mild pain as indicated by \>25/100 on a 100mm visual analogue scale (VAS) (Sanchez et al. 2011), or \<80/100 on HOOS JR with radiographic evidence of Kellgren-Lawrence grades 1-3 hip OA will be invited to participate in this study.

The preparation of PRP is a simple tissue fractionation using centrifugation with EmCyte PurePRP Supraphysiologic SP kit \[EmCyte Corp. Fort Myers FL\]. Platelet quantification analysis is performed using the Horiba ABX Micros ES 60 \[Plymouth Medical\]. Primary outcome measures are indicated by overall hip pain severity by HOOS JR and VAS patient reported outcome measures.

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2021-08-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-09
• Primary Completion: 2021-12-01
• Study Completion: 2022-08-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular LP-PRP Injection	Leukocyte-poor platelet rich plasma	A single injection of leukocyte poor platelet rich plasma (LP-PRP) will be administered to the intra-articular space under ultrasound guidance at the treatment visit.
Intra- and extra- articular LP-PRP Injection	Leukocyte-poor platelet rich plasma	A single injection of LP-PRP will be administered to the intra- articular space and the extra- articular structures under ultrasound guidance at the first visit.

Primary Outcome Measures

Name	Time	Method
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)	12 months	This is a patient-reported outcome measure for which scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating optimal hip health.
Numeric Rating Scale	12 months	This is a patient-reported outcome measure. Scores range from 0 to 10 with score of 0 indicating no pain and a score of 10 indicating most intense pain.

Trial Locations

Locations (1)

Regenerative Orthopedics and Sports Medicine; 🇺🇸 North Bethesda, Maryland, United States