Bone marrow concentrate vs steroid shot for hip osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, single-blind, two-arm study compares one-time bone marrow aspirate concentrate (BMAC) injections to Triamcinolone injections in adults with hip osteoarthritis. Participants are assigned to either intervention, with outcomes measured from baseline to 12 months using validated patient-reported scores. The trial uses a sham procedure in the Triamcinolone arm to maintain blinding for patients. Enrollment aims for 100 total participants (50 per arm) across a single-site setting, with safety monitored during the BMAC arm as results from culture are reviewed. Primary endpoints focus on changes in pain and function over follow-up visits at baseline, 6 weeks, 3 months, 6 months, and 12 months.

Why it matters

Who can join: the full rules

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 Total Score of 5 or higher in the Likert Scale (total score is 20)
5. Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays
6. Body Mass Index ≤ 35 kg/m\^2
7. Unilateral or Bilateral Hip Osteoarthritis
8. Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program
9. Agreement to adhere to Lifestyle Considerations
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. 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 m\^2
13. Thrombocytopenia with platelet count less than 150,000 x 10\^9 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

Where it's running

• Cleveland Clinic Florida
  Weston, Florida, United States Recruiting

Study contacts

• Principal investigator: Leonardo P Oliveira, Md — Cleveland Clinic Florida
• Study coordinator: Leonardo P Oliveira, Md
• Email: oliveil@ccf.org
• Phone: (954)659-5430

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.