Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

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, 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.

Conditions

• Hip Osteoarthritis

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.

Sponsors & Collaborators

• Lisa Dean Moseley Foundation

  collaborator UNKNOWN

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• LEONARDO P OLIVEIRA, MD · Cleveland Clinic Florida

• Carlos Higuera-Rueda, MD · Cleveland Clinic Florida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-15

Primary Completion

2027-07-31

Completion

2027-11-30

FDA Device

Yes

Countries

• United States

Study Locations