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

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Degeneration

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Leukocyte-poor platelet rich plasma
Sponsored by
Regenerative Orthopedics and Sports Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring platelet-rich plasma, leukocyte poor platelet rich plasma, PRP, hip osteoarthritis, osteoarthritis, Regenerative orthopedics and sports medicine, ROSM, EmCyte

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

  1. Symptomatic OA of hip (K-L Grade 1-3) documented by x-ray taken within the past 6 months
  2. Male or female age 30 - 65 at time of enrollment
  3. Patients must have adequate immune system function with no known immunodeficiency
  4. disease
  5. Has not had a corticosteroid injection in the past 6 months
  6. Has not used non-steroidal anti-inflammatory 7 days prior to treatment and has not used oral
  7. corticosteroids 30 days prior to treatment
  8. If on chronic anticoagulant medication, we will follow the recommendations of the physician
  9. managing their anticoagulant medication
  10. Willing and able to participate for the entire study period
  11. No evidence of current systemic infection or illness (eg. fever, malaise, etc.) and no evidence
  12. of skin infection in the areas where the injection will be performed

Exclusion:

  1. Patients have been diagnosed with an autoimmune disease, diabetes, rheumatoid arthritis,
  2. hematologic conditions predisposing to bleeding disorders or platelet dysfunction, Paget's disease of femur or ilium, avascular necrosis (AVN) of the femoral head, infectious arthritis, Lyme disease.
  3. Previous reparative cellular/ orthobiologics /PRP injection
  4. ≥7mm hip effusion as measured on ultrasound at the femoral neck
  5. K-L Grade 4 OA x-ray documented
  6. Patient has a history of alcohol or drug abuse within the six months prior to enrolment in the study
  7. Patients who had intra-articular treatment with corticosteroids within 6 months of randomization in this study
  8. Patient received more than 2 previous intra- or extra-articular corticosteroid injections to the affected hip.
  9. Patients who are pregnant or nursing at the time of consent
  10. Patients who have had anorexia, chronic insomnia, immunocompromised state, and/ or are on immunosuppressive medication
  11. Neoplastic cancer within 5 years prior to screening and no evidence of recurrence, except for cutaneous (basal cell and squamous cell) cancer treated with excision
  12. History of chemotherapy within the past 3 years or radiation therapy to the involved hip area
  13. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
  14. Patients who have had previous intervention to the hip except for labral repair/ reconstruction and/ or femoral neck osteoplasty or acetabular osteoplasty without microfracture.
  15. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
  16. Use of NSAID 7 days prior to treatment or oral or subcutaneous corticosteroids 30 days prior
  17. Patients with a BMI over 35
  18. Deformity or dysplasia (i.e. Legg Calve Perthes or DDH) other than FAI.
  19. Patients with systemic infection, hematological conditions, malignancy, blood borne diseases, allergies to lidocaine.

Sites / Locations

  • Regenerative Orthopedics and Sports MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intra-articular LP-PRP Injection

Intra- and extra- articular LP-PRP Injection

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
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
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.
Numeric Rating Scale
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.
Numeric Rating Scale
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.
Numeric Rating Scale
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.
Numeric Rating Scale
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.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
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.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
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.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
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.
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2020
Last Updated
September 2, 2021
Sponsor
Regenerative Orthopedics and Sports Medicine
Collaborators
EmCyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04241354
Brief Title
A Comparison of PRP Treatment to the IA vs. IA and EA Environments in Patients Diagnosed With Hip Osteoarthritis
Official Title
A Comparison of Platelet-rich Plasma Treatment to the Intra-articular vs. Intra- and Extra-articular Environments in Patients Diagnosed With Hip Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
August 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regenerative Orthopedics and Sports Medicine
Collaborators
EmCyte Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis, Degeneration
Keywords
platelet-rich plasma, leukocyte poor platelet rich plasma, PRP, hip osteoarthritis, osteoarthritis, Regenerative orthopedics and sports medicine, ROSM, EmCyte

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intra-articular LP-PRP Injection
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intra- and extra- articular LP-PRP Injection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Leukocyte-poor platelet rich plasma
Intervention Description
Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation [EmCyte Corp. Fort Myers FL].
Primary Outcome Measure Information:
Title
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
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.
Time Frame
baseline
Title
Numeric Rating Scale
Description
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.
Time Frame
baseline
Title
Numeric Rating Scale
Description
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.
Time Frame
6 weeks
Title
Numeric Rating Scale
Description
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.
Time Frame
4 months
Title
Numeric Rating Scale
Description
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.
Time Frame
6 months
Title
Numeric Rating Scale
Description
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.
Time Frame
12 months
Title
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
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.
Time Frame
6 weeks
Title
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
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.
Time Frame
4 months
Title
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
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.
Time Frame
6 months
Title
Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: Symptomatic OA of hip (K-L Grade 1-3) documented by x-ray taken within the past 6 months Male or female age 30 - 65 at time of enrollment Patients must have adequate immune system function with no known immunodeficiency disease Has not had a corticosteroid injection in the past 6 months Has not used non-steroidal anti-inflammatory 7 days prior to treatment and has not used oral corticosteroids 30 days prior to treatment If on chronic anticoagulant medication, we will follow the recommendations of the physician managing their anticoagulant medication Willing and able to participate for the entire study period No evidence of current systemic infection or illness (eg. fever, malaise, etc.) and no evidence of skin infection in the areas where the injection will be performed Exclusion: Patients have been diagnosed with an autoimmune disease, diabetes, rheumatoid arthritis, hematologic conditions predisposing to bleeding disorders or platelet dysfunction, Paget's disease of femur or ilium, avascular necrosis (AVN) of the femoral head, infectious arthritis, Lyme disease. Previous reparative cellular/ orthobiologics /PRP injection ≥7mm hip effusion as measured on ultrasound at the femoral neck K-L Grade 4 OA x-ray documented Patient has a history of alcohol or drug abuse within the six months prior to enrolment in the study Patients who had intra-articular treatment with corticosteroids within 6 months of randomization in this study Patient received more than 2 previous intra- or extra-articular corticosteroid injections to the affected hip. Patients who are pregnant or nursing at the time of consent Patients who have had anorexia, chronic insomnia, immunocompromised state, and/ or are on immunosuppressive medication Neoplastic cancer within 5 years prior to screening and no evidence of recurrence, except for cutaneous (basal cell and squamous cell) cancer treated with excision History of chemotherapy within the past 3 years or radiation therapy to the involved hip area Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis) Patients who have had previous intervention to the hip except for labral repair/ reconstruction and/ or femoral neck osteoplasty or acetabular osteoplasty without microfracture. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments. Use of NSAID 7 days prior to treatment or oral or subcutaneous corticosteroids 30 days prior Patients with a BMI over 35 Deformity or dysplasia (i.e. Legg Calve Perthes or DDH) other than FAI. Patients with systemic infection, hematological conditions, malignancy, blood borne diseases, allergies to lidocaine.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wesley McClure, BA
Phone
1-(301)-906-8294
Email
Research@rosm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean W Mulvaney, MD
Organizational Affiliation
Regenerative Orthopedics and Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regenerative Orthopedics and Sports Medicine
City
North Bethesda
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wesley McClure, BA
Phone
301-906-8294
Email
research@rosm.org
First Name & Middle Initial & Last Name & Degree
Sean W Mulvaney, MD

12. IPD Sharing Statement

Learn more about this trial

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

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