NCT04241354

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

A Comparison of Platelet-rich Plasma Treatment to the Intra-articular vs. Intra- and Extra-articular Environments in Patients Diagnosed With Hip Osteoarthritis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Regenerative Orthopedics and Sports Medicine · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Hip
• Osteoarthritis
• Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	Leukocyte-poor platelet rich plasma	Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation \[EmCyte Corp. Fort Myers FL\].

Timeline

• Start date: 2021-08-25
• Primary completion: 2021-12-01
• Completion: 2022-08-25
• First posted: 2020-01-27
• Last updated: 2021-09-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study