Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.