Clinical Research Study

ROSM RESEARCH STUDY

PLATELET-RICH PLASMA FOR HIP OSTEOARTHRITIS ELIGIBILITY SCREENING

This page provides additional information on Regenerative Orthopedics and Sports Medicine’s IRB approved (IRCM-2019-208) research study on the use of platelet rich plasma (PRP) for hip osteoarthritis.

PRP FOR HIP OSTEOARTHRITIS STUDY GENERAL INFORMATION

What is a research study?

Research studies help us learn more about a problem and how to better address it. In medical research, we aim to learn more about diseases and how to treat them.

What is the purpose of this study?

As leaders in the field of regenerative orthopedics, Regenerative Orthopedics and Sports Medicine (ROSM) physicians are dedicated to advancing our field through their contributions to clinical research. The purpose of this study is to compare patient-reported outcomes of two platelet- rich plasma (PRP) treatment approaches for hip osteoarthritis (OA) to determine whether or not one is more effective than the other.

Do I have to participate in this study?

No, participation in this study is entirely voluntary. Your care at ROSM will not be affected by your decision to participate, or not participate, in this study. If you decide to participate, you may withdraw from the study at any point over the course of the year. Your completed pain questionnaires will be saved in your medical record.

What are the benefits of participating in this study?

PRP has level 1 evidence to support its use in Osteoarthritis, and it is significantly less invasive treatment option than surgery. The PRP treatment will be provided to you at no cost. Your participation in this study will help us make contributions to the growing field of regenerative orthopedic medicine and help future patients.

What are the risks of participating in this study?

There are no risks that would result from your participation in this study other than to those associated with a standard PRP treatment at ROSM. Please refer to our PRP treatment information sheet for more information on PRP. Your physician can answer any questions you have about any risks associated with PRP treatments.

Will I learn the results of this study?

As a participant in the study, you have the option to receive updates on where and when results from our study will be shared with the community. Your pain questionnaire data will be accessible to you and will be stored in your medical record.

What does this study involve?

Patients are required to complete the screening process prior to being enrolled in the study. This involves answering eligibility screening questions and obtaining an X-ray to determine your eligibility. Qualified patients will receive one PRP treatment.

Patients will be asked to sign a consent script and complete two brief questionnaires four times over the course of the year following their PRP treatment. The Visual Analogue Scale (VAS) will ask patients to indicate their average pain on a 0-10 scale. The HOOS JR questionnaire is a 6 question survey about pain and function. Study participants will receive one PRP treatment and will complete the first questionnaire at the clinic prior to the procedure. Patients will complete the last three questionnaires remotely by email or using the Data Biologics application at 4, 6, and 12 months after the treatment.

What is Data Biologics?

Data Biologics is an electronic data collection system that uses standardized pain and function measurement surveys to track patient outcomes for various orthopedic conditions. Surveys can be completed using the Data Biologics mobile application or by email, and all responses are saved in a secure database.

Who will have access to the questionnaires I complete?

Your completed questionnaires will be accessible to researchers and medical staff at ROSM. The information we use from your survey will not be tied to your personal information (name, date of birth, etc.).

Will I have to pay anything to participate in the study?

One PRP treatment will be provided to you at no cost. Your X-ray, evaluation visit, and follow-up visits will be billed to your insurance. Uninsured patients who are interested in participating in this study should contact us at research@rosm.org for more information.

Additional Information:

If you are interested in participating in this study, please complete the eligibility screening questionnaire. If you are deemed eligible to participate, a research coordinator will contact you at the telephone number or email address you provide on the Eligibility Screening Questionnaire.

STUDY CRITERIA

Study Patient Requirements

Patients must be able to travel to a ROSM clinic for an evaluation to determine study eligibility. We require all prospective study patients to have an X-Ray in AP, Lateral, and Frog-leg views with Kellgren-Lawrence grading within the last 6 months prior to the evaluation visit. Travel costs will be the responsibility of the patient.

If deemed eligible, patients must be willing to complete 4 weeks of Physical Therapy and all follow-up surveys following treatment.

Inclusion Criteria – Patients must meet all inclusion criteria to be eligible

1. Symptomatic OA of hip (K-L Grade 1-3) documented by x-ray taken within the past 6 months

2. 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. If on chronic anticoagulant medication, we will follow the recommendations of the physician managing their anticoagulant medication if they can safely come off of their anticoagulation medication 5 days prior to blood draw. If not, they are excluded.

7. Willing and able to participate for the entire study period

8. 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: Patients who meet any of the below criteria are not eligible to participate

    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.
Prospective eligible participants can complete the eligibility screening questionnaire to proceed with the screening process.