Clinical trial NCT05859269: Methylprednisolone Taper After Total Knee Replacement
Official title: Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Knee Arthritis
Keywords: Methylprednisolone
Total Knee Replacement
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.

Detailed description: The study aims to evaluate the efficacy of a post-operative course of glucocorticoids on pain, range of motion, and extremity function after total knee replacement surgery. The goal is to compare the effects of a Medrol dose pak administration to the standard of care, which includes a single intraoperative dose of 10 mg intravenous dexamethasone, on postoperative outcomes. The study is important in the field because it aims to evaluate the effectiveness of glucocorticoids in reducing pain, nausea, and opioid consumption following total knee replacement surgery. The study will provide valuable insight into the role and optimal dosing of oral glucocorticoids after total knee replacement surgery (TKA). The results of this study could potentially improve postoperative outcomes for patients undergoing TKA. The study population in this randomized control trial consists of patients undergoing total knee replacement surgery. Patients will be randomly assigned to one of two treatment arms: (1) a single intraoperative dose of 10 mg intravenous dexamethasone (control group) or (2) a single intraoperative dose of 10 mg intravenous dexamethasone followed by a 6-day oral methylprednisolone taper course. The study does not mention any populations of increased concern. The study will last approximately 6 months with encounters at normal times within the clinic. The Emory r extremity surgeons will personally contact all patients for 1-day post-operation (standard of care for them) and at 7-10 days. Recruitment will occur at Emory University Orthopaedics \& Spine Hospital. The study team will enroll 100 patients per group - 200 total.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
* Patients of the ages of 18 and 95 years.

Exclusion Criteria:

* Patients with concurrent and significant injuries to other bones or organs.
* Minors unable to consent for participation in the study.
* Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
* Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.

Primary outcomes:
measure: Changes in Pain Score during Follow up period
timeFrame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
measure: Changes in Nausea score during Follow Up Period
timeFrame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Secondary outcomes:
measure: Changes in the postoperative range of motion following total knee arthroplasty (TKA)
timeFrame: Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
measure: Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
measure: Compare patient satisfaction with acute postoperative pain control
timeFrame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
measure: Compare the postoperative opiate consumption measured as the number of tablets taken
timeFrame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Musculoskeletal Institute
state: Georgia
city: Tucker
country: United States
facility: Emory University Orthopaedics & Spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Ajay Premkumar, MD
role: PRINCIPAL_INVESTIGATOR
References: