Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial

Launched by RUSH UNIVERSITY MEDICAL CENTER · Dec 14, 2016

Keywords

ClinConnect Summary

As non-surgical treatments of OA are essential, multiple trials have been done to compare standard of care IA injection therapies to more novel injection treatments, with many of these trials using saline as the control arm. The purpose of using a control arm is to attempt to eliminate placebo effect and help distinguish the true effectiveness of a therapy. There has been controversy over the clinical effect of saline in treating OA with some arguing that saline may have some clinical benefit. If this is true, it could allow for the true effect of standard of care therapies to appear dimini...

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Eligibility criteria

• Inclusion Criteria:
• • 1. The patient must be between the ages of 18 and 80
• • 2. Informed consent has been obtained from the patient
• • 3. The patient must have diagnosed symptomatic osteoarthritis of the tibio-femoral or patello-femoral compartment of the target knee for at least 1 month
• • 4. The patient has moderate-to-severe knee pain reflected by an average visual analogue scale (VAS) score of 4 or greater (out of a possible 10) over the previous 7 days.
• • 5. Radiographic imaging must show grade II-III osteoarthritis on the Kellgren \& Lawrence Scale.
• • 6. Patients may have bilateral osteoarthritis but only patients with unilateral symptoms may be included.
• Exclusion Criteria:
• • 1. Knee instability
• • 2. A score less than 4 (out of a possible 10) on their intake VAS
• • 3. Major axial deviation (\>5º valgus or varus deviation as evidenced on a standard of care x-ray.
• • 4. Previous surgery at the target knee \< 6 months.
• • 5. Symptomatic osteoarthritis of the contralateral knee or any other joint.
• • 6. Systemic or intra articular injection to any joint with corticosteroids within 6 months prior to screening
• • 7. Previous joint injection of any type in the past 6 months
• • 8. Systemic conditions that could interfere with outcome such as Rheumatoid arthritis, coagulopathy, and anemia.
• • 9. Allergy to any of the injected substances.
• • 10. Any patient unable to cease NSAID usage (other than low dose aspirin) due to unrelated condition.
• • 11. Cognitive impairment or unable to provide informed consent
• • 12. Recent knee trauma with violation of the intra-articular bone.