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Not yet recruiting NCT07630896

Post-op Prednisone and Glucose Monitoring in TKA

Phase IV Interventional Osteoarthritis Unicompartmental Knee Arthroplasty Total Hip Arthroplasty (THA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prednisone, Continuous Glucose Monitor, InkWell Health Tattoos.
Who it may be relevant to
Registry conditions: Osteoarthritis, Unicompartmental Knee Arthroplasty, Total Hip Arthroplasty (THA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Pain at Rest [Time frame: 2 weeks]
  • Pain with Ambulation [Time frame: 2 weeks]
Secondary outcome measures (5)
  • Swelling [Time frame: 2 weeks]
  • Range of Motion [Time frame: 2 weeks]
  • Opioid Consumption [Time frame: 2 weeks]
  • Continuous Glucose Levels [Time frame: 2 weeks]
  • Adverse Outcomes [Time frame: 2 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT07630896 · AAAV7556

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗