Arthritis KneePhase 4NCT06489626
The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty
A Phase 4 study testing Methylprednisolone 4 milligram Tab and Dexamethasone injection in people with Arthritis Knee and Knee Osteoarthritis, run by F. Johannes Plate at 2 sites in United States.
Trial summary
Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis Knee, Knee Osteoarthritis, Pain, Postoperative
- What is being tested?
- Methylprednisolone 4 milligram Tab and Dexamethasone injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2025to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patients indicated for primary total knee arthroplasty.
- Access to computer or smartphone for completion of REDCap surveys
Who cannot join
- Patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an HgbA1c >6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. Those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC East
Monroeville, Pennsylvania, 15146
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.
- Conditions
- Arthritis Knee, Knee Osteoarthritis, Pain, Postoperative
- Being tested
- Methylprednisolone 4 milligram Tab, Dexamethasone injection
- Keywords
- total knee arthroplasty, knee osteoarthritis, pain management
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 4 milligram TabDrug
6-day 4 milligram methylprednisolone oral taper
Dexamethasone injectionDrug
4 milligram intravenous dexamethasone will be administered intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative and Post-operative steroid | Experimental | Patients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper Receives: Drug: Methylprednisolone 4 milligram Tab; Drug: Dexamethasone injection |
| Intraoperative Steroid | Active comparator | Patients randomized to this group will only receive intraoperative intravenous dexamethasone Receives: Drug: Dexamethasone injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Pain at rest and with movement
numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain
Measured: daily for two weeks
Prescription narcotic usage
Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication
Measured: daily for two weeks
Sleep disturbance
Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time
Measured: daily for two weeks
Knee Range of motion
goniometric measurement of knee extension and flexion
Measured: 2-week, 6-week and 3-month postoperative visits
Secondary outcomes (2)
Wound healing
Surgical site will be evaluated for normal wound healing
Measured: 2-week, 6-week and 3-month postoperative visits
Knee Injury and Osteoarthritis Outcome Scores
Questionnaire assessing for function will be administered (0= extreme problems present, 100= no problems present)
Measured: 2-week, 6-week and 3-month postoperative visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Nov 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Why it stopped: withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- F. Johannes Plate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, F. Johannes Plate, University of Pittsburgh
- Investigators
- Johannes F Plate, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489626
- Sponsor's protocol ID
- STUDY24010173
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
PubMed 38316236Gottschalk MB, Dawes A, Hurt J, Spencer C, Campbell C, Toston R, Farley K, Daly C, Wagner ER. A Prospective Randomized Controlled Trial of Methylprednisolone for Postoperative Pain Management of Surgically Treated Distal Radius Fractures. J Hand Surg Am. 2022 Sep;47(9):866-873. doi: 10.1016/j.jhsa.2022.06.008.
PubMed 36058564
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06489626
- Acronym / sponsor ID
- STUDY24010173
- Conditions
- Arthritis Knee, Knee Osteoarthritis, Pain, Postoperative
- Keywords
- total knee arthroplasty, knee osteoarthritis, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- F. Johannes PlateUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Jul 2024 (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.
Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative and Post-operative steroid | Experimental | Drug: Methylprednisolone 4 milligram Tab, Drug: Dexamethasone injectionPatients in this groups will receive intraoperative intravenous dexamethasone as well as a 6-day post-operative methylprednisolone taper |
| Intraoperative Steroid | Active comparator | Drug: Dexamethasone injectionPatients randomized to this group will only receive intraoperative intravenous dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients indicated for primary total knee arthroplasty.
- Access to computer or smartphone for completion of REDCap surveys
Key exclusion criteria (1 listed)
- Patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an HgbA1c >6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. Those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.
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 |
|---|---|---|
| Methylprednisolone 4 milligram Tab6-day 4 milligram methylprednisolone oral taper | Drug | Intraoperative and Post-operative steroid |
| Dexamethasone injection4 milligram intravenous dexamethasone will be administered intraoperatively | Drug | Intraoperative Steroid, Intraoperative and Post-operative steroid |
Primary outcome
Daily Pain at rest and with movement
Time frame: daily for two weeks
numeric rating scale from 0 to 10 (0=minimal, 10=maximal) will be used to capture patient experienced pain
Prescription narcotic usage
Time frame: daily for two weeks
Oral morphine equivalent units will be collected based on patient usage of prescribed narcotic pain medication
Sleep disturbance
Time frame: daily for two weeks
Patients will be asked if pain caused them to be awoken in the night and if so what level of pain they were experiencing at that time
Knee Range of motion
Time frame: 2-week, 6-week and 3-month postoperative visits
goniometric measurement of knee extension and flexion
2 secondary outcomes
Wound healing
Time frame: 2-week, 6-week and 3-month postoperative visits
Knee Injury and Osteoarthritis Outcome Scores
Time frame: 2-week, 6-week and 3-month postoperative visits
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Background: PubMed 38316236Wagner ER, Hussain ZB, Karzon AL, Cooke HL, Toston RJ, Hurt JT, Dawes AM, Gottschalk MB. Methylprednisolone taper is an effective addition to multimodal pain regimens after total shoulder arthroplasty: results of a randomized controlled trial: 2022 Neer Award winner. J Shoulder Elbow Surg. 2024 May;33(5):985-993. doi: 10.1016/j.jse.2023.12.016. Epub 2024 Feb 4.
- Background: PubMed 36058564Gottschalk MB, Dawes A, Hurt J, Spencer C, Campbell C, Toston R, Farley K, Daly C, Wagner ER. A Prospective Randomized Controlled Trial of Methylprednisolone for Postoperative Pain Management of Surgically Treated Distal Radius Fractures. J Hand Surg Am. 2022 Sep;47(9):866-873. doi: 10.1016/j.jhsa.2022.06.008.
- 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. This study is not recruiting at the moment.
Johannes F Plate principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone 4 milligram Tab and Dexamethasone injection in people with Arthritis Knee and Knee Osteoarthritis, run by F. Johannes Plate at 2 sites 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Daily Pain at rest and with movement (time frame: daily for two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06489626, which also lists 2 linked publications.
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 5 Feb 2026.