N/A
N=90
Steroid Injection vs. BioDRestore for Patients With Knee OA
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02767492 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Visual Analog Pain Score — 2.49; 3.25 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BioD Restore (Device); Kenalog (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Hawkins Foundation
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Pain Score |
2.49; 3.25 | — |
| PRIMARY Veterans Rand 12 Item Health Survey |
56.95; 58.01 | — |
| PRIMARY Lysholm Knee Score |
75.26; 61.00 | — |
| PRIMARY Single Alpha Numeric Evaluation (SANE) |
66.14; 60.49 | — |
| PRIMARY Knee Injury and Osteoarthritis Outcome Score (KOOS) |
64.10; 55.67 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02767492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.