Steroid Injection vs. BioDRestore for Patients With Knee OA
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/22/2019 |
| Start Date: | May 2016 |
| End Date: | December 2019 |
| Contact: | Eric Newton, MSEd, ATC |
| Email: | eric.newton@hawkinsfoundation.com |
| Phone: | 864-454-7458 |
A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
This study will include patients who are diagnosed with knee OA and are recommended for a
knee injection. Study subjects will be randomized to receive either the standard of care knee
injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked
for permission for a baseline knee aspiration prior to the knee injection. At 6 months
post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be
followed for 1 year post-injection to include range of motion measurements and
patient-reported pain/functional outcome measurements. X-rays will also be taken at the
1-year post-injection appointment.
knee injection. Study subjects will be randomized to receive either the standard of care knee
injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked
for permission for a baseline knee aspiration prior to the knee injection. At 6 months
post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be
followed for 1 year post-injection to include range of motion measurements and
patient-reported pain/functional outcome measurements. X-rays will also be taken at the
1-year post-injection appointment.
Inclusion Criteria:
- Male or female, aged 18 to 80 years.
- Willing and able to give voluntary informed consent to participate in this
investigation.
- Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA
diagnosed and confirmed by treating physician using standing x-ray).
- Candidate for intra-articular knee injection.
- BMI < 40
Exclusion Criteria:
- Patients who have received intra-articular injection(s) in the last 3 months.
- Patients who have undergone arthroscopic surgery on the study knee in the past year.
- Patients who have undergone arthroplasty on the study knee.
- Ligament instability
- Diabetes (Type 1 or II)
- Inflammatory arthropathies.
- Fibromyalgia or chronic fatigue syndrome.
- Female patient who is pregnant or nursing.
- Chronic use of narcotics.
- Any other reason (in the judgment of the investigator).
We found this trial at
1
site
Greenville, South Carolina 29615
Principal Investigator: Paul Siffri, MD
Phone: 864-454-7458
Click here to add this to my saved trials
