Recruiting
Phase 1

PRP vs. IA

Sponsor:

Regenerative Orthopedics and Sports Medicine

Code:

NCT04241354

Conditions

Osteoarthritis, Hip

Osteoarthritis

Degeneration

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

Interventions

Leukocyte-poor platelet rich plasma

Study Details

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

Study ID

NCT04241354

Start date

Aug 25, 2021

Status verified date

Sep, 2021

Completion date

Aug 25, 2022

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Leukocyte-poor platelet rich plasma

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

Primary outcome measure

  • Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: baseline ]
  • Numeric Rating Scale [ Time Frame: baseline ]
  • Numeric Rating Scale [ Time Frame: 6 weeks ]
  • Numeric Rating Scale [ Time Frame: 4 months ]
  • Numeric Rating Scale [ Time Frame: 6 months ]
  • Numeric Rating Scale [ Time Frame: 12 months ]
  • Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 6 weeks ]
  • Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 4 months ]
  • Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 6 months ]
  • Hip Osteoarthritis Outcome Score for Joint Replacement (HOOS JR) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Regenerative Orthopedics and Sports Medicine

Recruiting

North Bethesda, Maryland, United States, 20852

Contacts

Principal Investigator:

Sean W Mulvaney, MD

More Information

Sponsor

Regenerative Orthopedics and Sports Medicine

Last update posted

Sep 9, 2021

Last verified

Sep, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Regenerative Orthopedics and Sports Medicine on 2021-09-09.