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 saline injection in the past 6 months

5. Has not used non-steroidal anti inflammatory 7 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 saline within 6 months of randomization in this study
  10. Patients who are pregnant or nursing at the time of consent
  11. Patients who have had anorexia, chronic insomnia, immunocompromised state, and/ or are on immunosuppressive medication
  12. 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
  13. History of chemotherapy within the past 3 years or radiation therapy to the involved hip area
  14. Patients with inflammatory arthritic conditions (e.g. rheumatoid arthritis)
  15. Patients who have had previous intervention to the hip except for labral repair/ reconstruction and/ or femoral neck osteoplasty or acetabular osteoplasty without microfracture.
  16. Additional disabilities in any of the lower limbs that would interfere with any of the clinical assessments.
  17. Use of NSAID 7 days prior to treatment in 30 days prior
  18. Patients with a BMI over 35
  19. 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.

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