Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

NCT ID
NCT04990128
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Phase 3
Sponsor
The Cleveland Clinic

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 100 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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 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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Florida, United States: 1

Sample of listed locations

  • Cleveland Clinic Florida — Weston, Florida, 33331, United States — Site recruitment status not specified in the registry data

Study details

Start date
August 28, 2026
Primary completion date
October 1, 2027
First posted
August 4, 2021

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT04990128
Registry last updated
September 9, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT04990128 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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