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

Study Purpose

The purpose of this study is to evaluate the efficacy of one 5 ml leukocyte-poor platelet-rich plasma (LP-PRP) injection to the intra-articular (IA) space in comparison to one 5 ml LP-PRP injection to the IA space with the addition of 3 ml 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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 30 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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 disease 4. Has not had a corticosteroid injection in the past 6 months 5. Has not used non-steroidal anti inflammatory 7 days prior to treatment and has not used oral corticosteroids 30 days prior to treatment 6. Willing and able to participate for the entire study period 7. 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 Criteria:

1. 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. 2. Patients who are taking anticoagulant medication including Aspirin [60] 3. Patients who have a local skin infection at the treatment site 4. Patients with a history of thrombocytopenia (platelet count of <100,000 platelets/ μL) and/ or hypofibrinogenemia 5. Previous reparative cellular/orthobiologic/PRP injection to the affected hip 6. ≥7mm hip effusion as measured on ultrasound at the femoral neck 7. K-L Grade 4 OA x-ray documented 8. Patient has a history of alcohol or drug abuse within the six months prior to enrolment in the study 9. Patients who had intra-articular treatment with corticosteroids within 6 months of randomization in this study 10. Patient received more than 2 previous intra- or extra-articular corticosteroid injections to the affected hip 11. Patients who are pregnant or nursing at the time of consent 12. Patients who have had anorexia, chronic insomnia, immunocompromised state, and/ or are on immunosuppressive medication 13. 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 14. History of chemotherapy within the past 3 years or radiation therapy to the involved hip area 15. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis) 16. Patients who have had previous intervention to the hip except for labral repair/ reconstruction and/ or femoral neck osteoplasty or acetabular osteoplasty without microfracture. 17. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments. 18. Use of NSAID 7 days prior to treatment or oral or subcutaneous corticosteroids 30 days prior 19. Patients with a BMI over 35 20. Deformity or dysplasia (i.e. Legg Calve Perthes or DDH) other than FAI.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04241354
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Regenerative Orthopedics and Sports Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sean W Mulvaney, MD
Principal Investigator Affiliation Regenerative Orthopedics and Sports Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

IndustryOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Osteoarthritis, Hip, Osteoarthritis, Degeneration
Additional Details

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.

Arms & Interventions

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

Biological: - Leukocyte-poor platelet rich plasma

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Annapolis, Maryland

Status

Recruiting

Address

Regenerative Orthopedics and Sports Medicine

Annapolis, Maryland, 21401

Site Contact

Tamara Ibrahim

research@rosm.org

301-503-9590