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NCT Number: NCT07630896

Post-op Prednisone and Glucose Monitoring in TKA

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rheumatic Diseases Signs and Symptoms Total Hip Arthroplasty (THA) Unicompartmental Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location contact

Roshan Shah, MD

CONTACT

Roshan Shah, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. Swelling

    Time frame: 2 weeks

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

  2. Range of Motion

    Time frame: 2 weeks

  3. Opioid Consumption

    Time frame: 2 weeks

  4. Continuous Glucose Levels

    Time frame: 2 weeks

  5. Adverse Outcomes

    Time frame: 2 weeks

    Total number of adverse events related to steroid treatment will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline Lenahan

CONTACT

[email protected]

(212) 305-8193

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Orthopaedic Scientific Research Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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