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Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04990128
Recruitment Status : Not yet recruiting
First Posted : August 4, 2021
Last Update Posted : February 21, 2022
Sponsor:
Collaborator:
Lisa Dean Moseley Foundation
Information provided by (Responsible Party):
LEONARDO OLIVEIRA, The Cleveland Clinic

Brief Summary:

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, endotoxin, 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.


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Combination Product: Aspire Needle + Emcyte PureBMC Drug: Triamcinolone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: bone marrow aspirate concentrate versus triamcinolone
Masking: Single (Participant)
Masking Description:

Participant will undergo a sham bone needling if assigned to Triamcinolone group to keep patient blinded to their intervention. This will simulate the bone marrow aspiration process.

Outcomes assessor will receive de-identified data including the treatment type.

Primary Purpose: Treatment
Official Title: Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024


Arm Intervention/treatment
Experimental: Bone marrow aspirate concentrate
Bone marrow that is aspirated then concentrated using a device.
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.

Active Comparator: Triamcinolone
Triamcinolone is a corticosteroid.
Drug: Triamcinolone
40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 6 Minute Walk Test (6MWT) [ 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. ]

    The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    This outcome is used to measure the farthest distance walked within 6 minutes.


  2. 6 Minute Walk Test (6MWT) [ 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. ]

    The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    This outcome is used to measure the farthest distance walked within 6 minutes.


  3. 6 Minute Walk Test (6MWT) [ 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. ]

    The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    This outcome is used to measure the farthest distance walked within 6 minutes.


  4. 6 Minute Walk Test (6MWT) [ 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. ]

    The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

    This outcome is used to measure the farthest distance walked within 6 minutes.



Other Outcome Measures:
  1. PROMIS - Physical Function (PROMIS-PF) [ 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 weeks. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  2. PROMIS - Physical Function (PROMIS-PF) [ 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. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  3. PROMIS - Physical Function (PROMIS-PF) [ 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. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  4. PROMIS - Physical Function (PROMIS-PF) [ 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. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  5. PROMIS - Pain Interference (PROMIS-PI) [ 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 weeks. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  6. PROMIS - Pain Interference (PROMIS-PI) [ 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. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  7. PROMIS - Pain Interference (PROMIS-PI) [ 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. ]
    All PROMIS instruments are calibrated to a mean t-score of 50 with a standard deviation of 10, with greater scores indicating more of the health domain in question (i.e., higher PROMIS-PF scores indicate greater function, whereas higher PROMIS-PI scores indicate that pain has a greater detriment on quality of life)

  8. Global Rate of Change (GRoC) [ 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 weeks. ]
    GRoC range from -7 to 7 with lower scores indicating worse change.

  9. Global Rate of Change (GRoC) [ 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. ]
    GRoC range from -7 to 7 with lower scores indicating worse change.

  10. Global Rate of Change (GRoC) [ 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. ]
    GRoC range from -7 to 7 with lower scores indicating worse change.

  11. Global Rate of Change (GRoC) [ 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. ]
    GRoC range from -7 to 7 with lower scores indicating worse change.

  12. Pittsburgh Sleep Quality Index [ 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 weeks. ]
    The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.

  13. Pittsburgh Sleep Quality Index [ 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. ]
    The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.

  14. Pittsburgh Sleep Quality Index [ 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. ]
    The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.

  15. Pittsburgh Sleep Quality Index [ 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. ]
    The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Traditionally, the items from the PSQI have been summed to create a total score to measure overall sleep quality.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 - 65 years old
  • WOMAC ≥ 50
  • Kellgren-Lawrence Grade 2 or higher on Hip X-Rays
  • Body Mass Index < 35 kg/m2
  • Unilateral or Bilateral Hip Osteoarthritis
  • Prior physical therapy treatment for 6 weeks in the last 6 months
  • Agreement to adhere to Lifestyle Considerations (see section 5.3)
  • At least 60 cc of BMAC acquired during aspiration/concentration process
  • Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
  • Patients with cancer in remission for at least 5 years
  • Total Nucleated cell count (TNC) ≥ 40 x 106 cells/mL
  • Platelet Concentration ≥ 600 x 106 cells/mL
  • Endotoxin < 0.5 EU/device output
  • Viability ≥ 90%
  • Negative gram stain result

Exclusion Criteria:

  • Prior corticosteroid injection to the hip
  • History of hip replacement(s)
  • Noncompliance to prevent screening tests for cancer indicated by age
  • Active autoimmune disease
  • Current use of oral corticosteroid
  • 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 < 12 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 109 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 and/or planning to become pregnant during trial
  • Breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04990128


Contacts
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Contact: LEONARDO P OLIVEIRA, MD (954)659-5430 olivei@ccf.org
Contact: Jillian King, BSc (954)659-6227 kingj19@ccf.org

Locations
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United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Contact: Leonardo Oliveira, MD    954-659-5430    oliveil@ccf.org   
Contact: Jillian King, BSc    (954)659-6227    kingj19@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Lisa Dean Moseley Foundation
Investigators
Layout table for investigator information
Principal Investigator: LEONARDO P OLIVEIRA, MD Cleveland Clinic Florida
Study Director: Carlos Higuera-Rueda, MD Cleveland Clinic Florida
Publications:

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Responsible Party: LEONARDO OLIVEIRA, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04990128    
Other Study ID Numbers: FLA 21-020
IDE 27066 ( Other Identifier: FDA )
First Posted: August 4, 2021    Key Record Dates
Last Update Posted: February 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by LEONARDO OLIVEIRA, The Cleveland Clinic:
bone marrow aspirate concentrate
triamcinolone
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs