Osteoarthritis, KneePhase 1NCT07070882
Oral Steroid Taper After Total Knee Arthroplasty
A Phase 1 study testing Methylprednisolone in people with Osteoarthritis, Knee, run by Columbia University at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Methylprednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2025to 20 Jun 2027
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing primary TKA with a diagnosis of osteoarthritis
- > 18 years old
- Willingness to undergo randomization
- Patients who will be home by postoperative day (POD) #1 to start the dosing schedule that day (includes both ambulatory and POD #1 discharge patients)
Who cannot join
- Reported chronic corticosteroid or opiate use prior to surgery
- Prior Open Surgery on the Ipsilateral Knee
- Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, septic arthritis, or postoperative traumatic arthritis
- American Society of Anesthesiologists (ASA) score ≥ 4
- Reported history of liver disease, renal disease, or diabetes mellitus
- Current systemic fungal infection or other local infection
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- Immunocompromised or immunosuppressed
- Current peptic ulcer disease
- History of psychosis, heart failure, myasthenia gravis, ocular herpes simplex virus, or systemic sclerosis
- Women with reported current pregnancy
- Known hypersensitivity to methylprednisolone
- ≤ 18 years old
- Inability to take oral medications
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Effectiveness of an Oral Methylprednisolone Taper Following Primary Total Knee Arthroplasty
This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA).
Read the detailed description
This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA). While intravenous (IV) corticosteroids have been shown to provide short-term pain relief in the immediate postoperative period, their effects are limited to the first 24 hours. Given the inflammatory nature of TKA recovery, extending steroid administration through an oral taper may provide additional benefits in pain control, opioid reduction, and functional recovery. This study will assess whether adding an oral steroid taper to standard multimodal pain management improves clinical outcomes in TKA patients.This prospective, single-blinded, randomized controlled trial will enroll adults aged 18 and older undergoing primary TKA for osteoarthritis at Columbia University Medical Center.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Methylprednisolone
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive a tapered dose of methylprednisolone with the standard of care pain management
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving oral methylprednisolone | Experimental | Patients receiving a six-day oral methylprednisolone taper (21 tablets, 4 mg each) in addition to standard multimodal pain management Receives: Drug: Methylprednisolone |
| Patients receiving standard pain management without the taper | No intervention | Patients receiving standard pain management without the taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean postoperative pain over post-operative days 1-6 (POD1-6)
Pain will be assessed using a 0-100 visual analog scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Pain will be assessed during knee flexion to 90 degrees and with ambulation, and daily scores will be averaged across post-operative days 1-6 (POD1-6) for each patient to derive the primary outcome.
Measured: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Secondary outcomes (5)
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
Patient will complete the KOOS Jr. The total score ranges from 0 indicating knee disability to 100 representing perfect knee health.
Measured: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6; first postoperative clinic visit (approximately 2 weeks); second postoperative visit (approximately 8 weeks)
Postoperative nausea and vomiting (PONV) score
Postoperative nausea and vomiting (PONV) will be assessed daily by telephone from post-operative days 1-6, where 0 indicates no nausea and 100 indicates the worst possible nausea or active vomiting.
Measured: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Daily opioid use
Daily opioid use will be recorded for POD1-6, including inpatient opioid administration on POD1, with patients reporting narcotic use for the preceding day. All opioids were converted to morphine milligram equivalents (MME) using the 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain. Conversion MMEs used were: 7.5 MME for oxycodone 5 mg, 10 MME for hydromorphone 2 mg, 10 MME for hydrocodone 10 mg, 10 MME for tramadol 50 mg.
Measured: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Ondansetron use
Patients will report the number of rescue ondansetron tablets taken during each 24-hour period over POD 1-6.
Measured: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Knee Range of motion (ROM)
Knee range of motion (ROM) will be measured by the attending surgeon using a goniometer at the first (approximately 2 weeks) and second postoperative visits (approximately 8 weeks). Changes in range of motion will be calculated relative to the preoperative baseline. For flexion, postoperative flexion minus preoperative flexion was used, with positive values indicating improved flexion. Extension was recorded as degrees of flexion contracture using positive values only; change in extension was calculated as preoperative minus postoperative extension, with positive values indicating improved extension.
Measured: first postoperative visit (approximately 2 weeks); second postoperative visits (approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start20 Jun 2025
- Primary completion1 Dec 2025
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert John Cooper, MD, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070882
- Sponsor's protocol ID
- AAAV7426
- Status last verified
- Apr 2026
- First submitted
- 28 Jun 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Oral Methylprednisolone Taper Following Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07070882
- Acronym / sponsor ID
- AAAV7426
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 17 Jul 2025 (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 aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA).
Detailed description
This study aims to evaluate the effectiveness of an oral methylprednisolone taper in reducing postoperative pain, opioid consumption, and nausea following primary total knee arthroplasty (TKA). While intravenous (IV) corticosteroids have been shown to provide short-term pain relief in the immediate postoperative period, their effects are limited to the first 24 hours. Given the inflammatory nature of TKA recovery, extending steroid administration through an oral taper may provide additional benefits in pain control, opioid reduction, and functional recovery. This study will assess whether adding an oral steroid taper to standard multimodal pain management improves clinical outcomes in TKA patients.This prospective, single-blinded, randomized controlled trial will enroll adults aged 18 and older undergoing primary TKA for osteoarthritis at Columbia University Medical Center.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving oral methylprednisolone | Experimental | Drug: MethylprednisolonePatients receiving a six-day oral methylprednisolone taper (21 tablets, 4 mg each) in addition to standard multimodal pain management |
| Patients receiving standard pain management without the taper | No intervention | –Patients receiving standard pain management without the taper |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient undergoing primary TKA with a diagnosis of osteoarthritis
- > 18 years old
- Willingness to undergo randomization
- Patients who will be home by postoperative day (POD) #1 to start the dosing schedule that day (includes both ambulatory and POD #1 discharge patients)
Key exclusion criteria (14 listed)
- Reported chronic corticosteroid or opiate use prior to surgery
- Prior Open Surgery on the Ipsilateral Knee
- Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, septic arthritis, or postoperative traumatic arthritis
- American Society of Anesthesiologists (ASA) score ≥ 4
- Reported history of liver disease, renal disease, or diabetes mellitus
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 |
|---|---|---|
| MethylprednisolonePatients will receive a tapered dose of methylprednisolone with the standard of care pain management | Drug | Patients receiving oral methylprednisolone |
Primary outcome
Mean postoperative pain over post-operative days 1-6 (POD1-6)
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Pain will be assessed using a 0-100 visual analog scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Pain will be assessed during knee flexion to 90 degrees and with ambulation, and daily scores will be averaged across post-operative days 1-6 (POD1-6) for each patient to derive the primary outcome.
5 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6; first postoperative clinic visit (approximately 2 weeks); second postoperative visit (approximately 8 weeks)
Postoperative nausea and vomiting (PONV) score
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Daily opioid use
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Ondansetron use
Time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
Knee Range of motion (ROM)
Time frame: first postoperative visit (approximately 2 weeks); second postoperative visits (approximately 8 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 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methylprednisolone in people with Osteoarthritis, Knee, 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 14 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: under way, not looking for participants, as of the sponsor's last update on 20 Apr 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean postoperative pain over post-operative days 1-6 (POD1-6) (time frame: Post-Operative Day 1, Day 2, Day 3, Day 4, Day 5, Day 6). 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 20 Apr 2026.