Health TrialsbyHealthPanel

Medrol Dosepak for Outpatient Total Knee Arthroplasty

ConditionTotal Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any patient undergoing primary TKA with a diagnosis of osteoarthritis

Willingness to undergo randomization

Disqualifiers

Reported chronic corticosteroid or opiate use

Suspected or confirmed periprosthetic joint infection

Revision TKA

Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylprednisolone

    Drug

    21 x 4mg tablets beginning on POD 1

  • Placebo

    Drug

    21 sugar tablets beginning on POD 1 with standard management

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Methylprednisolone taperExperimental treatment 1 intervention
Group B: Placebo taperPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid consumption at one-week postoperative

Relative difference in cumulative opioid consumption at Post-op day 7, measured in morphine equivalents.

Time frame
one week

Secondary outcomes

1

Patient reported outcome measures: Daily Visual Analogue Scale for Pain

Using Daily Visual Analogue Scale (VAS) pain score, scale of 1 to 10, 10 being the worst

Time frame
Week 1
2

Patient reported outcome measures : Daily Visual Analogue Scale for Pain

Using Daily Visual Analogue Scale (VAS) pain score, scale of 1 to 10, 10 being the worst

Time frame
3 weeks
3

Patient reported outcome measures: Daily Visual Analogue Scale for Pain

Using Daily Visual Analogue Scale (VAS) pain score, scale of 1 to 10, 10 being the worst

Time frame
6 weeks
4

Patient reported outcome measures: Daily Visual Analogue Scale of nausea

Daily visual analogue scale- nausea score, scale of 1 to 10, 10 being the worst

Time frame
Postoperative days 1 through 7 (week one)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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