Health TrialsbyHealthPanel

Post-op Prednisone and Glucose Monitoring in TKA

ConditionsOsteoarthritisUnicompartmental Knee ArthroplastyTotal Hip Arthroplasty (THA)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

This study compares the efficacy of a 5-day post-operative oral prednisone regimen (40 mg daily) with the standard intraoperative steroid regimen, focusing on pain, swelling, range of motion, opioid use, and glucose levels monitored continuously.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

MUST BE CONTACTED BY THE STUDY TEAM TO BE PART OF THE STUDY. No applications taken

Undergoing Primary Unicompartmental Knee Arthroplasty or Total Hip Arthroplasty

Age 18 and above

Patient at Columbia University Irving Medical Center and be undergoing planned surgery by Dr. Roshan P. Shah

Disqualifiers

Steroid therapy

Narcotic use within past 3 months

History of corticosteroid intolerance

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prednisone

    Drug

    40 mg daily for 5 days

  • Continuous Glucose Monitor

    Device

    Provides real-time glucose readings for up to 14 days

  • InkWell Health Tattoos

    Other intervention

    Temporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Post-operative SteroidsActive comparator 3 interventions
Group B: Standard of carePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Pain at Rest

Pain intensity at rest will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain.

Time frame
2 weeks
2

Pain with Ambulation

Pain intensity with ambulation will be measured using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The NRS is a validated and standardized tool for assessing patient-reported pain.

Time frame
2 weeks

Secondary outcomes

1

Swelling

Knee joint circumference will be measured in centimeters at the joint line.

Time frame
2 weeks
2

Range of Motion

Time frame
2 weeks
3

Opioid Consumption

Time frame
2 weeks
4

Continuous Glucose Levels

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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

Columbia University

Lead sponsor

Orthopaedic Scientific Research Foundation

Collaborator

Source ClinicalTrials.gov
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