Arthritis Knee, Knee Osteoarthritis, Pain, Postoperative
Conditions
Keywords
total knee arthroplasty, knee osteoarthritis, pain management
Brief summary
Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.
Interventions
DRUGMethylprednisolone 4 milligram Tab
6-day 4 milligram methylprednisolone oral taper
4 milligram intravenous dexamethasone will be administered intraoperatively
Sponsors
F. Johannes Plate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients indicated for primary total knee arthroplasty. * Access to computer or smartphone for completion of REDCap surveys
Exclusion criteria
* Patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an HgbA1c \>6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. Those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Pain at rest and with movement | daily for two weeks | numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain |
| Prescription narcotic usage | daily for two weeks | Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication |
| Sleep disturbance | daily for two weeks | Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time |
| Knee Range of motion | 2-week, 6-week and 3-month postoperative visits | goniometric measurement of knee extension and flexion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing | 2-week, 6-week and 3-month postoperative visits | Surgical site will be evaluated for normal wound healing |
| Knee Injury and Osteoarthritis Outcome Scores | 2-week, 6-week and 3-month postoperative visits | Questionnaire assessing for function will be administered (0= extreme problems present, 100= no problems present) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohannes F Plate
University of Pittsburgh
Outcome results
None listed