Post-op Prednisone and Glucose Monitoring in TKA

June 3, 2026 updated by: Roshan P. Shah, Columbia University

Postoperative Prednisone Regimen in TKA and Its Effect on Continuous Glucose Levels

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center
        • Contact:
          • Roshan Shah, MD
        • Principal Investigator:
          • Roshan Shah, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing Primary Unicompartmental Knee Arthroplasty or Total Hip Arthroplasty
  • Age 18 and above

Exclusion Criteria:

  • Steroid therapy
  • Narcotic use within past 3 months
  • History of corticosteroid intolerance
  • Pregnancy
  • Uncontrolled diabetes
  • Doesn't own smart phone

Drop Criteria:

- 2nd dose of IV dexamethasone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Post-operative Steroids
Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively.
Drug: Prednisone
40 mg daily for 5 days
Device: Continuous Glucose Monitor
Provides real-time glucose readings for up to 14 days
Other: InkWell Health Tattoos
Temporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion
Placebo Comparator: Standard of care
Participants will receive standard of care treatment, consisting of the intravenous administration of dexamethasone and periarticular administration of steroids intraoperatively.
Device: Continuous Glucose Monitor
Provides real-time glucose readings for up to 14 days
Other: InkWell Health Tattoos
Temporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at Rest
Time Frame: 2 weeks
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.
2 weeks
Pain with Ambulation
Time Frame: 2 weeks
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of Motion
Time Frame: 2 weeks
2 weeks
Swelling
Time Frame: 2 weeks
Knee joint circumference will be measured in centimeters at the joint line.
2 weeks
Opioid Consumption
Time Frame: 2 weeks
2 weeks
Continuous Glucose Levels
Time Frame: 2 weeks
2 weeks
Adverse Outcomes
Time Frame: 2 weeks
Total number of adverse events related to steroid treatment will be recorded.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Orthopaedic Scientific Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV7556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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