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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