NCT04990128 · The Cleveland Clinic
Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
What this study is about
This is a single site, randomly assigned single blinded, two treatment group$1 study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis.
View original scientific description
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, 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.
Interventions
COMBINATION_PRODUCT
Aspire Needle + Emcyte PureBMC
The Aspire Needle will be utilized to extract the bone marrow and the Emcyte PureBMC will be used to concentrate bone marrow aspirate. The final concentrate will be injected into the hip.
DRUG
Triamcinolone
40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.
Primary outcome measures
Western Ontario McMaster Universities Arthritis Index (WOMAC)
Time frame: 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 6 weeks.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario McMaster Universities Arthritis Index (WOMAC)
Time frame: 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 3 months.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario McMaster Universities Arthritis Index (WOMAC)
Time frame: 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 6 months.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Western Ontario McMaster Universities Arthritis Index (WOMAC)
Time frame: 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.
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Provision of signed and dated consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged between 18 - 75 years old
- WOMAC Pain Subscale Total Score of 5 or higher in the Likert Scale (total score is 20)
- Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays
- Body Mass Index ≤ 35 kg/m\^2
- Unilateral or Bilateral Hip Osteoarthritis
- Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program
- Agreement to adhere to Lifestyle Considerations
- Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
- 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
- Negative gram stain result
Exclusion criteria
- Prior corticosteroid injection to the hip
- History of hip replacement(s)
- Noncompliance to preventive screening tests for cancer indicated by age
- Active autoimmune disease
- Current use of oral corticosteroid
- Use of immunosuppressive medications, or who are known to me immunocompromised
- Inability to be weaned of oral anti-inflammatory medications
- History of Diabetes or HbA1c ≥ 6.5%
- Uncontrolled Thyroid Dysfunction: 0.450 uIU/mL ≥ TSH levels ≥ 4.500 uIU/mL
- Vitamin D Level \< 30 ng/ml
- Anemia (Hgb \< 11.7 g/dL for Women; Hgb \< 13 g/dL for men)
- eGFR \< 60 mL/min/1.73 m\^2
- Thrombocytopenia with platelet count less than 150,000 x 10\^9 L
- Patients with coagulopathies based on known clotting disorder
- Patients currently on anti-coagulation therapies
- Patients who report any active infection(s) including cellulitis, TB, HIV, COVID, Hepatitis B and C
- Moving over the next year
- Inability to consent to the research study
- Inability to complete forms electronically
- Subjects in any other clinical trials
- History of allergic reaction to lidocaine
- Pregnancy or planning to be pregnant during trial
- Breastfeeding
Where
- Weston, Florida
Collaborators
Lisa Dean Moseley Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2026 · Source of record for eligibility and locations