Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis

FLA 21-020

This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows: Specific Aim 1: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection. Specific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time. Specific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score. Hypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected. The investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, endotoxin, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient. Patients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.

2024-07-01

2025-07-01

2028-07-01

Not yet recruiting

Early phase I

100

Inclusion: 1. Provision of signed and dated consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged between 18 - 75 years old 4. WOMAC Pain Subscale With Average Score(Total WOMAC Pain Score Divided by 5) Equal to 4 or higher 5. Kellgren-Lawrence Grade \> 2 on Hip X-Rays 6. Body Mass Index \< 35 kg/m2 7. Unilateral or Bilateral Hip Osteoarthritis 8. Prior physical therapy treatment for 6 weeks in the last 6 months 9. Agreement to adhere to Lifestyle Considerations (see section 5.3) 10. Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements 11. Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy/radiation therapy such as breast cancer, colon cancer, or skin cancer, and others could participate when deemed in remission for 1 year. Written approval from oncologist will be necessary prior to enrollment 12. Endotoxin less than or equal to 0.5 EU/ml 13. Negative gram stain result Exclusion: 1. Prior corticosteroid injection to the hip 2. History of hip replacement(s) 3. Noncompliance to preventive screening tests for cancer indicated by age 4. Active autoimmune disease 5. Current use of oral corticosteroid 6. Use of immunosuppressive medications, or who are known to me immunocompromised 7. Inability to be weaned of oral anti-inflammatory medications 8. History of Diabetes or HbA1c \> 6.5% 9. Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL 10. Vitamin D Level \< 30 ng/ml 11. Anemia (Hgb \< 11.7 g/dL for Women; Hgb \< 13 g/dL for men) 12. eGFR \< 60 mL/min/1.73 m2 13. Thrombocytopenia with platelet count less than 150,000 x 109 L 14. Patients with coagulopathies based on known clotting disorder 15. Patients currently on anti-coagulation therapies 16. Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C 17. Moving over the next year 18. Inability to consent to the research study 19. Inability to complete forms electronically 20. Subjects in any other clinical trials 21. History of allergic reaction to lidocaine 22. Pregnancy or planning to be pregnant during trial 23. Breastfeeding

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'bone marrow aspirate concentrate versus triamcinolone', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Participant will undergo a sham bone needling if assigned to Triamcinolone group to keep patient blinded to their intervention. This will simulate the bone marrow aspiration process.\n\nOutcomes assessor will receive de-identified data including the treatment type.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-05-01