Hip Osteoarthritis study: Triamcinolone
Official title Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis
ClinicalTrials.gov ID: NCT04990128
What this study is testing
What is Aspire Needle + Emcyte PureBMC?
An investigational combination of a bone marrow aspiration device and a bone marrow concentrate being studied for hip osteoarthritis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a bone marrow concentrate injection can reduce hip pain and improve walking better than a steroid injection over one year.
- Who it's for
- You may be able to join if you have hip osteoarthritis and are looking for new treatment options.
- What's involved
- You will receive one injection into your hip. One group gets bone marrow concentrate, the other gets a steroid. You will have visits at 6 weeks, 3 months, 6 months, and 12 months for pain and walking tests.
- Time commitment
- The study lasts one year with four follow‑up visits after the injection.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
See the full eligibility 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...
- 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
- people in any other clinical trials
- History of allergic reaction to lidocaine
- Pregnancy or planning to be pregnant during trial
- Breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Weston, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Weston, Florida, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.