Osteoarthritis Clinical Trial
Official title:
A Comparison of Platelet-rich Plasma Treatment to the Intra-articular vs. Intra- and Extra-articular Environments in Patients Diagnosed With Hip Osteoarthritis
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).
Status | Recruiting |
Enrollment | 84 |
Est. completion date | August 25, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Regenerative Orthopedics and Sports Medicine | North Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Regenerative Orthopedics and Sports Medicine | EmCyte Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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