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Trial record 1 of 1 for:    NCT04241354
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A Comparison of PRP Treatment to the IA vs. IA and EA Environments in Patients Diagnosed With Hip Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04241354
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
EmCyte Corporation
Information provided by (Responsible Party):
Regenerative Orthopedics and Sports Medicine

Study Description
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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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Osteoarthritis Degeneration Biological: Leukocyte-poor platelet rich plasma Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : August 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intra-articular LP-PRP Injection
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.
 Biological: Leukocyte-poor platelet rich plasma
Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation [EmCyte Corp. Fort Myers FL].
Experimental: Intra- and extra- articular LP-PRP Injection
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.
 Biological: Leukocyte-poor platelet rich plasma
Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation [EmCyte Corp. Fort Myers FL].


Outcome Measures
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Primary Outcome Measures :
  1. Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: baseline ]
    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.

  2. Numeric Rating Scale [ Time Frame: baseline ]
    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.

  3. Numeric Rating Scale [ Time Frame: 6 weeks ]
    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.

  4. Numeric Rating Scale [ Time Frame: 4 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.

  5. Numeric Rating Scale [ Time Frame: 6 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.

  6. Numeric Rating Scale [ Time Frame: 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.

  7. Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 6 weeks ]
    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.

  8. Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 4 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.

  9. Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 6 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.

  10. Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241354


Contacts
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Contact: Wesley McClure, BA 1-(301)-906-8294 Research@rosm.org

Locations
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United States, Maryland
Regenerative Orthopedics and Sports Medicine Recruiting
North Bethesda, Maryland, United States, 20852
Contact: Wesley McClure, BA    301-906-8294    research@rosm.org   
Principal Investigator: Sean W Mulvaney, MD         
Sponsors and Collaborators
Regenerative Orthopedics and Sports Medicine
EmCyte Corporation
Investigators
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Principal Investigator: Sean W Mulvaney, MD Regenerative Orthopedics and Sports Medicine
More Information
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Responsible Party: Regenerative Orthopedics and Sports Medicine
ClinicalTrials.gov Identifier: NCT04241354    
Other Study ID Numbers: ROSM-HO-001
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021

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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
Keywords provided by Regenerative Orthopedics and Sports Medicine:
platelet-rich plasma
leukocyte poor platelet rich plasma
PRP
hip osteoarthritis
 osteoarthritis
Regenerative orthopedics and sports medicine
ROSM
EmCyte
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases