Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Aspire Needle + Emcyte PureBMC
Combination productThe 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.
Triamcinolone
Drug40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1% that will be injected into the hip.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Bone marrow aspirate concentrateExperimental treatment 1 intervention
Group B: TriamcinoloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Western Ontario McMaster Universities Arthritis Index (WOMAC)
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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.2
Western Ontario McMaster Universities Arthritis Index (WOMAC)
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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.3
Western Ontario McMaster Universities Arthritis Index (WOMAC)
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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.4
Western Ontario McMaster Universities Arthritis Index (WOMAC)
WOMAC Scores range from 0 to 96, with higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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.Secondary outcomes
1
6 Minute Walk Test (6MWT)
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.
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.2
6 Minute Walk Test (6MWT)
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.
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.3
6 Minute Walk Test (6MWT)
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.
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.4
6 Minute Walk Test (6MWT)
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.
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.Other outcomes
1
PROMIS - Physical Function (PROMIS-PF)
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)
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.2
PROMIS - Physical Function (PROMIS-PF)
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)
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.3
PROMIS - Physical Function (PROMIS-PF)
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)
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.4
PROMIS - Physical Function (PROMIS-PF)
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)
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
Lisa Dean Moseley Foundation
Collaborator
Source ClinicalTrials.gov