Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

Launched by THE CLEVELAND CLINIC · Aug 3, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different treatments for hip osteoarthritis, a painful condition affecting the hip joint. The researchers want to see how effective a treatment called bone marrow aspirate concentrate (BMAC) is compared to a steroid injection called triamcinolone. They will look at how much pain patients have and how well they can move and walk over a year after receiving one of these injections. The hope is that while the steroid may provide quicker relief, the BMAC treatment could lead to longer-lasting benefits.

To participate in the trial, individuals should be between 18 and 75 years old and have a certain level of hip pain and joint damage as seen on X-rays. They should have already tried physical therapy and be willing to follow the study rules. Participants will receive either the BMAC or the steroid injection, and both treatments will be guided by ultrasound to ensure accuracy. The trial is not currently recruiting, but it's an opportunity for those struggling with hip osteoarthritis to potentially find a more effective treatment option.

Gender

ALL

Eligibility criteria

• 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 greater than or equal to 2 on Hip X-Rays
• • 6. Body Mass Index less than or equal to 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