NCT07630896

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
20mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

May 26, 2026

Last Update Submit

June 3, 2026

Conditions

OsteoarthritisTotal Hip Arthroplasty (THA)Unicompartmental Knee Arthroplasty

Keywords

Post-operative painPrednisoneContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 weeks

  • 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.

    2 weeks

Secondary Outcomes (5)

  • Swelling

    2 weeks

  • Range of Motion

    2 weeks

  • Opioid Consumption

    2 weeks

  • Continuous Glucose Levels

    2 weeks

  • Adverse Outcomes

    2 weeks

Study Arms (2)

Post-operative Steroids

ACTIVE COMPARATOR

Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively.

Drug: PrednisoneDevice: Continuous Glucose MonitorOther: InkWell Health Tattoos

Standard of care

PLACEBO COMPARATOR

Participants will receive standard of care treatment, consisting of the intravenous administration of dexamethasone and periarticular administration of steroids intraoperatively.

Device: Continuous Glucose MonitorOther: InkWell Health Tattoos

Interventions

PrednisoneDRUG

40 mg daily for 5 days

Post-operative Steroids
Continuous Glucose MonitorDEVICE

Provides real-time glucose readings for up to 14 days

Post-operative SteroidsStandard of care
InkWell Health TattoosOTHER

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

Post-operative SteroidsStandard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

OsteoarthritisPain, Postoperative

Interventions

Prednisone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Jacqueline Lenahan

CONTACT

(212) 305-8193jl5092@cumc.columbia.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Russell A. Hibbs Associate Professor of Orthopedics in Orthopedic Surgery and in Surgery

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 5, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)