Arthritis Knee, Arthritis of Hip
Conditions
Brief summary
Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis. Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage. Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.
Interventions
DRUGKetorolac Intraarticular Injection
Injections will be given under ultrasound guidance with one of two possible medications.
DRUGTriamcinolone Intraarticular Injection
Injections will be given under ultrasound guidance with one of two possible medications.
Sponsors
Saint Alphonsus Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Symptomatic, radiographically proven degenerative joint disease in the hip or knee
Exclusion criteria
* recent injection in the hip or knee within the previous 3 months * history of traumatic osteoarthritis or ligamentous reconstruction * chronic narcotic use * history of inflammatory or neuropathic arthropathy * pregnant and/or nursing women * allergy or strong reaction to study medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (Baseline to One Week Post-injection) | Comparing baseline to one week post-injection | Pain Score |
| Change in Visual Analogue Scale (Baseline to One Month Post-injection) | Comparing baseline to one month post-injection | Pain Score |
| Change in Visual Analogue Scale (Baseline to Three Months Post-injection) | Comparing baseline to three months post-injection | Pain Score |
| Change in PROMIS Global Health Scores (Baseline to One Week Post-injection) | Comparing baseline to one week post-injection | Overall patient wellbeing |
| Change in PROMIS Global Health Scores (Baseline to One Month Post-injection) | Comparing baseline to one month post-injection | Overall patient wellbeing |
| Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection) | Comparing baseline to three months post-injection | Overall patient wellbeing |
| Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection) | Comparing baseline to one week post-injection | Functionality and pain of affected knee |
| Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection) | Comparing baseline to one month post-injection | Functionality and pain of affected knee |
| Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection) | Comparing baseline to three months post-injection | Functionality and pain of affected knee |
| Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection) | Comparing baseline to one week post-injection | Functionality and pain of affected hip |
| Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection) | Comparing baseline to one month post-injection | Functionality and pain of affected hip |
| Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection) | Comparing baseline to three months post-injection | Functionality and pain of affected hip |
Countries
United States
Outcome results
None listed