ClinicalTrials.gg
RecruitingNCT07630896Updated Oct 2, 2026

Post-op Prednisone and Glucose Monitoring in TKA

A Phase 4 interventional study of Prednisone and Continuous Glucose Monitor in Osteoarthritis, Unicompartmental Knee Arthroplasty and Total Hip Arthroplasty (THA), sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Columbia University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 2, 2026Eligibility revisedGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,029 studies in Osteoarthritis with a site in United States — 117 open to participants now, 177 under way, 14 of them phase 3. Osteoarthritis · United States.

Planned enrollment
402nd of 832
104 · median 100
Started
2026
with 36 others
Phase 4
74 of 1,029
11 open now
Primary completion
2027-12
later than 115 of 176 live
Registered
1,019th of 1,029
by date

Among the 1,029 studies in Osteoarthritis with a site in United States, this one is the 402nd largest by planned enrollment of the 832 interventional ones, is one of 37 that started in 2026, is one of 74 in phase 4, reaches primary completion later than 115 of the 176 other live ones, and was the 1,019th registered.

By phase

1,029 studies; the count open now beside each. This study's row is marked.

No phase437 · 55 open
Observational189 · 25 open
Phase 3128 · 8 open
Phase 2121 · 9 open
Phase 4this study74 · 11 open
Phase 145 · 6 open
Phase 1/219 · 3 open
Phase 2/315 · 0 open
Other kind1 · 0 open

By the year they started

First in 1977; this study’s year is marked. 37 started in 2026.

Size and results

Median enrollment 100 across the 832 interventional studies, 114 across the 188 observational. Of the 758 that completed or were terminated, 338 (45%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 1,029 studies in Osteoarthritis with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Osteoarthritis
  • Unicompartmental Knee Arthroplasty
  • Total Hip Arthroplasty (THA)

Keywords

  • Post-operative pain
  • Prednisone
  • Continuous Glucose Monitoring
04

Who can participate

The criteria were revised on the registry on Oct 2, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    Post-operative Steroids

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

    Drug: Prednisone · Device: Continuous Glucose Monitor · Other: InkWell Health Tattoos

  • 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 · Other: InkWell Health Tattoos

Interventions

  • 40 mg daily for 5 days

  • DeviceContinuous Glucose Monitor

    Provides real-time glucose readings for up to 14 days

  • OtherInkWell Health Tattoos

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

06

What researchers measure

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

  5. Adverse Outcomes

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

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
    Recruiting
    • Roshan Shah, MD · Contact
    • Roshan Shah, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.

Of 54 non-industry phase 4 interventional studies under Osteoarthritis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 18 months is below that.

Counting every sponsor, half of 63 studies reached it within 28 months; a quarter within 11 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
May 26, 2026
First posted
Jun 5, 2026
StartActual
Jun 22, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Mar 2028
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
2 inclusion criteria added
What changed in the criteria
Inclusion criteria
  • AddedMUST BE CONTACTED BY THE STUDY TEAM TO BE PART OF THE STUDY. No applications taken
  • AddedPatient at Columbia University Irving Medical Center and be undergoing planned surgery by Dr. Roshan P. Shah
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Eligibility 2 inclusion criteria added
    What changed in the criteria
    Inclusion criteria
    • AddedMUST BE CONTACTED BY THE STUDY TEAM TO BE PART OF THE STUDY. No applications taken
    • AddedPatient at Columbia University Irving Medical Center and be undergoing planned surgery by Dr. Roshan P. Shah

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07630896
Collaborators
Orthopaedic Scientific Research Foundation
Responsible party
Roshan P. Shah (Russell A. Hibbs Associate Professor of Orthopedics in Orthopedic Surgery and in Surgery, Columbia University) — Principal investigator
First posted
Jun 5, 2026
Start date
Jun 22, 2026
Primary completion
Dec 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Oct 2, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Prednisone

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