OsteoarthritisPhase 4NCT07630896
Post-op Prednisone and Glucose Monitoring in TKA
A Phase 4 study testing Prednisone, Continuous Glucose Monitor and InkWell Health Tattoos in people with Osteoarthritis and Unicompartmental Knee Arthroplasty, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Unicompartmental Knee Arthroplasty, Total Hip Arthroplasty (THA)
- What is being tested?
- Prednisone, Continuous Glucose Monitor and InkWell Health Tattoos
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2026to Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Roshan Shah, MD
Roshan Shah, MD
About this study
Official title: 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.
- Being tested
- Prednisone, Continuous Glucose Monitor, InkWell Health Tattoos
- Keywords
- Post-operative pain, Prednisone, Continuous Glucose Monitoring
- Medical subject headings
- Osteoarthritis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
40 mg daily for 5 days
Continuous Glucose MonitorDevice
Provides real-time glucose readings for up to 14 days
InkWell Health TattoosOther
Temporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion
| Study group | Role | What they receive |
|---|---|---|
| Post-operative Steroids | Active comparator | Participants will receive a 5-day regimen of 40 mg oral prednisone postoperatively. Receives: Drug: Prednisone; Device: Continuous Glucose Monitor; Other: 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. Receives: Device: Continuous Glucose Monitor; Other: InkWell Health Tattoos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (5)
Swelling
Knee joint circumference will be measured in centimeters at the joint line.
Measured: 2 weeks
Range of Motion
Measured: 2 weeks
Opioid Consumption
Measured: 2 weeks
Continuous Glucose Levels
Measured: 2 weeks
Adverse Outcomes
Total number of adverse events related to steroid treatment will be recorded.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start22 Jun 2026
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Scientific Research Foundation
- Responsible party
- Principal investigator, Roshan P. Shah, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630896
- Sponsor's protocol ID
- AAAV7556
- Status last verified
- Sep 2026
- First submitted
- 26 May 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Prednisone Regimen in TKA and Its Effect on Continuous Glucose Levels
- ClinicalTrials.gov ID
- NCT07630896
- Acronym / sponsor ID
- AAAV7556
- Keywords
- Post-operative pain, Prednisone, Continuous Glucose Monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Orthopaedic Scientific Research Foundation
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-operative Steroids | Active comparator | Drug: Prednisone, Device: Continuous Glucose Monitor, Other: InkWell Health TattoosParticipants will receive a 5-day regimen of 40 mg oral prednisone postoperatively. |
| Standard of care | Placebo comparator | Device: Continuous Glucose Monitor, Other: InkWell Health TattoosParticipants will receive standard of care treatment, consisting of the intravenous administration of dexamethasone and periarticular administration of steroids intraoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Steroid therapy
- Narcotic use within past 3 months
- History of corticosteroid intolerance
- Pregnancy
- Uncontrolled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone40 mg daily for 5 days | Drug | Post-operative Steroids |
| Continuous Glucose MonitorProvides real-time glucose readings for up to 14 days | Device | Post-operative Steroids, Standard of care |
| InkWell Health TattoosTemporary medical-grade tattoos that provide real-time monitoring of knee swelling and range of motion | Other | Post-operative Steroids, Standard of care |
Primary outcome
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.
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone, Continuous Glucose Monitor and InkWell Health Tattoos in people with Osteoarthritis and Unicompartmental Knee Arthroplasty, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Lenahan ((212) 305-8193, jl5092@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at Rest (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.