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NCT04990128 · ClinicalTrials.gov registry record · Phase 3
Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
A Phase 3 study, sponsored by The Cleveland Clinic.
- Not yet
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT04990128 is a Phase 3 study that has not yet begun recruiting, run by The Cleveland Clinic. The registered enrollment target is 100 participants.
The verdict
NCT04990128, a Phase 3 study, has not yet begun recruiting, sponsored by The Cleveland Clinic.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study 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, platelet concentration, vol
Interventions
- DRUG Triamcinolone
- COMBINATION_PRODUCT Aspire Needle + Emcyte PureBMC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-06-23 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04990128
The ClinicalTrials.gov registry entry for NCT04990128 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Triamcinolone is the first listed.
NCT04990128 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04990128 about?
NCT04990128 is a clinical study titled "Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis". 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...
What is the current status of trial NCT04990128?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2026-06-23. Estimated completion is 2027-11.
What interventions are being tested in trial NCT04990128?
The interventions under investigation include: Triamcinolone (DRUG), Aspire Needle + Emcyte PureBMC (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04990128?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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