The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty

F. Johannes Plate

Status and phase: Withdrawn; Phase 4

Conditions: Arthritis Knee; Pain, Postoperative; Knee Osteoarthritis

Treatments: Drug: Dexamethasone injection; Drug: Methylprednisolone 4 milligram Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT06489626

STUDY24010173

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Intraoperative and Post-operative steroid

Experimental group

Description:

Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper

Treatment:

Drug: Dexamethasone injection

Drug: Methylprednisolone 4 milligram Tab

Intraoperative Steroid

Active Comparator group

Description:

Patients randomized to this group will only receive intraoperative intravenous dexamethasone

Treatment:

Drug: Dexamethasone injection