Clinical trial NCT06489626: The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty
Official title: The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Arthritis Knee
Knee Osteoarthritis
Pain, Postoperative
Keywords: total knee arthroplasty
knee osteoarthritis
pain management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Daily Pain at rest and with movement
timeFrame: daily for two weeks
measure: Prescription narcotic usage
timeFrame: daily for two weeks
measure: Sleep disturbance
timeFrame: daily for two weeks
measure: Knee Range of motion
timeFrame: 2-week, 6-week and 3-month postoperative visits
Secondary outcomes:
measure: Wound healing
timeFrame: 2-week, 6-week and 3-month postoperative visits
measure: Knee Injury and Osteoarthritis Outcome Scores
timeFrame: 2-week, 6-week and 3-month postoperative visits
Other outcomes:
measure: Postoperative complications
timeFrame: To occur at 30 and 90 days postoperatively
Locations:
city: Monroeville
country: United States
facility: UPMC East
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Johannes F Plate
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
citation: Gottschalk MB, Dawes A, Hurt J, Spencer C, Campbell C, Toston R, Farley K, Daly C, Wagner ER. A Prospective Randomized Controlled Trial of Methylprednisolone for Postoperative Pain Management of Surgically Treated Distal Radius Fractures. J Hand Surg Am. 2022 Sep;47(9):866-873. doi: 10.1016/j.jhsa.2022.06.008.