Weston, FLNCT04990128Now EnrollingIRB Ready

Hip Osteoarthritis Clinical Trial in Weston, FL

Access cutting-edge hip osteoarthritis treatment through this phase 3 clinical trial at a research site in Weston. Study-provided care at no cost to qualified participants.

Sponsored by The Cleveland Clinic

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Expert Care in Weston

Access hip osteoarthritis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hip osteoarthritis treatment provided free

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Check if you qualify for this hip osteoarthritis clinical trial in Weston, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Weston

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Weston site if eligible
  4. 4Begin participation

About This Hip Osteoarthritis Study in Weston

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.

Sponsor: The Cleveland Clinic

Who Can Participate

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 - 75 years old
WOMAC Pain Subscale Total Score of 5 or higher in the Likert Scale (total score is 20)
Kellgren-Lawrence Grade ≥ 2 on Hip X-Rays
Body Mass Index ≤ 35 kg/m\^2
Unilateral or Bilateral Hip Osteoarthritis
Prior physical therapy treatment for 6 weeks in the last 12 months and compliance with home exercise program
Agreement to adhere to Lifestyle Considerations
Discontinuation of pain/anti-inflammatory medications 2 week prior to baseline measurements
Patients with cancer in remission for at least 5 years. Specific cancers which were treated with surgical resection and are not undergoing chemotherapy/radiation therapy such as breast cancer, colon cancer, or skin cancer, and others could participate when deemed in remission for 1 year. Written approval from oncologist will be necessary prior to enrollment
Negative gram stain result

Exclusion Criteria

Prior corticosteroid injection to the hip
History of hip replacement(s)
Noncompliance to preventive screening tests for cancer indicated by age
Active autoimmune disease
Current use of oral corticosteroid
Use of immunosuppressive medications, or who are known to me immunocompromised
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 \< 11.7 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 10\^9 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 or planning to be pregnant during trial
Breastfeeding

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Weston?

Yes, this clinical trial (NCT04990128) has an active research site in Weston, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hip Osteoarthritis Treatment Options in Weston, FL

If you're searching for hip osteoarthritis treatment options in Weston, FL, this clinical trial (NCT04990128) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Weston research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced hip osteoarthritis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hip osteoarthritis clinical trials near you to find additional studies recruiting in your area.

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