Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Orthopaedic Scientific Research Foundation | UNKNOWN |
Not provided
Not provided
Not provided
This study compares the efficacy of a 5-day post-operative oral prednisone regimen (40 mg daily) with the standard intraoperative steroid regimen, focusing on pain, swelling, range of motion, opioid use, and glucose levels monitored continuously.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-operative Steroids | Active Comparator | Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively. |
|
| Standard of care | Placebo Comparator | Participants will receive standard of care treatment, consisting of the intravenous administration of dexamethasone and periarticular administration of steroids intraoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 40 mg daily for 5 days |
| |
| Continuous Glucose Monitor |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Rest | Pain intensity at rest will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain. | 2 weeks |
| Pain with Ambulation | Pain intensity with ambulation will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Swelling | Knee joint circumference will be measured in centimeters at the joint line. | 2 weeks |
| Range of Motion | 2 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Drop Criteria:
- 2nd dose of IV dexamethasone
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Lenahan | Contact | (212) 305-8193 | jl5092@cumc.columbia.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Provides real-time glucose readings for up to 14 days |
|
| InkWell Health Tattoos | Other | Temporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion |
|
| Opioid Consumption |
| 2 weeks |
| Continuous Glucose Levels | 2 weeks |
| Adverse Outcomes | Total number of adverse events related to steroid treatment will be recorded. | 2 weeks |
| D011183 |
| Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |