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

NCT04241354 | Unknown Phase 1 FDA Drug

• 1 other identifier: ROSM-HO-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Hip; Osteoarthritis; Degeneration

Keywords

platelet-rich plasma; leukocyte poor platelet rich plasma; PRP; hip osteoarthritis; osteoarthritis; Regenerative orthopedics and sports medicine; ROSM; EmCyte

Outcome Measures

Primary Outcomes (10)

• 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.

  baseline

• 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.

  baseline

• 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.

  6 weeks

• 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.

  4 months

• 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.

  6 months

• 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.

  12 months

• 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.

  6 weeks

• 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.

  4 months

• 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.

  6 months

• 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.

  12 months

Study Arms (2)

Intra-articular LP-PRP Injection

ACTIVE COMPARATOR

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

Intra- and extra- articular LP-PRP Injection

EXPERIMENTAL

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

Interventions

Leukocyte-poor platelet rich plasma BIOLOGICAL

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

Intra- and extra- articular LP-PRP Injection; Intra-articular LP-PRP Injection

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regenerative Orthopedics and Sports Medicine: lead
• EmCyte Corporation: collaborator

Study Sites (1)

Regenerative Orthopedics and Sports Medicine

North Bethesda, Maryland, 20852, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Sean W Mulvaney, MD

  Regenerative Orthopedics and Sports Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley McClure, BA

CONTACT

1-(301)-906-8294; Research@rosm.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: August 25, 2021
• Primary Completion: December 1, 2021
• Study Completion: August 25, 2022
• Last Updated: September 9, 2021

Record last verified: 2021-09

Locations

US (1)