Knee ArthritisPhase 4NCT05859269
Methylprednisolone Taper After Total Knee Replacement
A Phase 4 study testing Methylprednisolone in people with Knee Arthritis, run by Emory University at 2 sites in United States.
Trial summary
Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2023to 23 Jul 2025
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- Patients of the ages of 18 and 95 years.
Who cannot join
- Patients with concurrent and significant injuries to other bones or organs.
- Minors unable to consent for participation in the study.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory Musculoskeletal Institute
Atlanta, Georgia, 30329
Emory University Orthopaedics & Spine Hospital
Tucker, Georgia, 30084
About this study
Official title: Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial
Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.
Read the detailed description
The study aims to evaluate the efficacy of a post-operative course of glucocorticoids on pain, range of motion, and extremity function after total knee replacement surgery. The goal is to compare the effects of a Medrol dose pak administration to the standard of care, which includes a single intraoperative dose of 10 mg intravenous dexamethasone, on postoperative outcomes. The study is important in the field because it aims to evaluate the effectiveness of glucocorticoids in reducing pain, nausea, and opioid consumption following total knee replacement surgery. The study will provide valuable insight into the role and optimal dosing of oral glucocorticoids after total knee replacement surgery (TKA). The results of this study could potentially improve postoperative outcomes for patients undergoing TKA. The study population in this randomized control trial consists of patients undergoing total knee replacement surgery. Patients will be randomly assigned to one of two treatment arms: (1) a single intraoperative dose of 10 mg intravenous dexamethasone (control group) or (2) a single intraoperative dose of 10 mg intravenous dexamethasone followed by a 6-day oral methylprednisolone taper course. The study does not mention any populations of increased concern. The study will last approximately 6 months with encounters at normal times within the clinic. The Emory r extremity surgeons will personally contact all patients for 1-day post-operation (standard of care for them) and at 7-10 days. Recruitment will occur at Emory University Orthopaedics \& Spine Hospital. The study team will enroll 100 patients per group - 200 total.
- Conditions
- Knee Arthritis
- Being tested
- Methylprednisolone, Standard of Care
- Keywords
- Methylprednisolone, Total Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course.
Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care.
Standard of CareOther
Patients will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care).
Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: Medrol Dose | Experimental | The perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables. Receives: Drug: Methylprednisolone |
| Control Group: Standard of Care | Active comparator | Patients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care). Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Score during Follow up period
A pain assessment will be assessed at each post-operative visit via the Visual Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain).
Pain will be assessed at rest and during active movement of extremity. Patients will also be asked to fill out the VAS-pain score each day until post-op day 7.
Measured: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Changes in Nausea score during Follow Up Period
: A nausea assessment will be assessed at each post-operative visit via the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 7. Patients will also be monitored for post-operative vomiting.
Measured: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Secondary outcomes (4)
Changes in the postoperative range of motion following total knee arthroplasty (TKA)
Range of motion (ROM) assessment will take place at each clinic followed up with a hand-held goniometer. This will be done by assessing the total flexion-extension arc of the knee. ROM will be assessed as well in the preoperative holding area prior to surgery
Measured: Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)
The Patient-Related Knee Evaluation surveys. They have been used / validated in several studies and have a strong correlation with other scores. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. These scores (and the KOOS, which the attending physician performs at follow up clinics after TKA) will be administered at each post-operative follow up.
Measured: Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Compare patient satisfaction with acute postoperative pain control
Patients will be asked about their pain control and satisfaction with the procedure and whether it meets or exceeds their expectations. The rating scale is much worse than expected, worse than expected, as expected, better than expected, or much better than expected.
Measured: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Compare the postoperative opiate consumption measured as the number of tablets taken
Narcotic usage will be monitored, and the patient will be asked to count the amount of pain pills taken daily and this will be reported as part of the pain diary for the first 7 days.
Measured: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start16 Oct 2023
- Primary completion23 Jul 2025
- Study completion23 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Emory 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ajay Premkumar, Emory University
- Investigators
- Ajay Premkumar, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859269
- Sponsor's protocol ID
- STUDY00005985
- Status last verified
- Sep 2025
- First submitted
- 5 May 2023
- Last updated
- 18 Sep 2025
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Taper After Total Knee Replacement: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05859269
- Acronym / sponsor ID
- STUDY00005985
- Conditions
- Knee Arthritis
- Keywords
- Methylprednisolone, Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 23 Jul 2025 (actual)
- First posted
- 15 May 2023 (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.
Total knee replacement surgery is a commonly performed and widely successful surgery to improve mobility and decrease pain in patients suffering from severe knee arthritis. However, in the immediate period after knee replacement, patients often experience significant pain and nausea, which can limit early recovery after surgery. Glucocorticoids are anti-inflammatory drugs that can reduce pain and swelling by blocking the inflammatory process, and have already shown promise in various surgical settings, including after knee replacement. There are different glucocorticoid formulations available, and in this particular study, we are evaluating the effects of administering a Medrol Dose Pak, which is a commonly available glucocorticoid taper that is administered over a short period of time after surgery. Our hypothesis is that the administration of the Medrol Dose Pak will lead to decreased pain, nausea, and opioid consumption in the weeks following total knee replacement.
Detailed description
The study aims to evaluate the efficacy of a post-operative course of glucocorticoids on pain, range of motion, and extremity function after total knee replacement surgery. The goal is to compare the effects of a Medrol dose pak administration to the standard of care, which includes a single intraoperative dose of 10 mg intravenous dexamethasone, on postoperative outcomes. The study is important in the field because it aims to evaluate the effectiveness of glucocorticoids in reducing pain, nausea, and opioid consumption following total knee replacement surgery. The study will provide valuable insight into the role and optimal dosing of oral glucocorticoids after total knee replacement surgery (TKA). The results of this study could potentially improve postoperative outcomes for patients undergoing TKA. The study population in this randomized control trial consists of patients undergoing total knee replacement surgery. Patients will be randomly assigned to one of two treatment arms: (1) a single intraoperative dose of 10 mg intravenous dexamethasone (control group) or (2) a single intraoperative dose of 10 mg intravenous dexamethasone followed by a 6-day oral methylprednisolone taper course. The study does not mention any populations of increased concern. The study will last approximately 6 months with encounters at normal times within the clinic. The Emory r extremity surgeons will personally contact all patients for 1-day post-operation (standard of care for them) and at 7-10 days. Recruitment will occur at Emory University Orthopaedics \& Spine Hospital. The study team will enroll 100 patients per group - 200 total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: Medrol Dose | Experimental | Drug: MethylprednisoloneThe perioperative Medrol dose treatment will consist of a course that lasts six days, with 24 milligrams administered on the first day, 20 milligrams on the second day, 60 milligrams on the third day, 12 milligrams on the fourth day, 8 milligrams on the fifth day, and 4 milligrams on the sixth day. Patients will then be followed up at the clinic for six weeks following their procedure to allow for clinical evaluation and to measure outcome variables. |
| Control Group: Standard of Care | Active comparator | Other: Standard of CarePatients in this group will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care). |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee.
- Patients of the ages of 18 and 95 years.
Key exclusion criteria (4 listed)
- Patients with concurrent and significant injuries to other bones or organs.
- Minors unable to consent for participation in the study.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
- Patients with pre-existing immune suppression, where further immune suppression with glucocorticoids could warrant unwarranted or unneeded risk.
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 single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course. Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care. | Drug | Experimental Group: Medrol Dose |
| Standard of CarePatients will receive a single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care). Patients will also receive a standardized multimodal postoperative pain management regimen which includes nonsteroidal anti-inflammatory medication (e.g., NSAIDs) and opioid pain medications, both in the hospital and at home as part of standard care. | Other | Control Group: Standard of Care |
Primary outcome
Changes in Pain Score during Follow up period
Time frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
A pain assessment will be assessed at each post-operative visit via the Visual Analog Pain Scale (VAS-pain), which is ranked from 0 (no pain) to 10 (highest amount of pain). Pain will be assessed at rest and during active movement of extremity. Patients will also be asked to fill out the VAS-pain score each day until post-op day 7.
Changes in Nausea score during Follow Up Period
Time frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
: A nausea assessment will be assessed at each post-operative visit via the Visual Analog Nausea Scale (VAS-nausea), which is ranked from 0 (no nausea) to 10 (highest amount of nausea). Patients will be asked to fill out the VAS-nausea each day until post-operative day 7. Patients will also be monitored for post-operative vomiting.
4 secondary outcomes
Changes in the postoperative range of motion following total knee arthroplasty (TKA)
Time frame: Immediately before the surgery, Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Changes in post operative knee function utilizing Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Compare patient satisfaction with acute postoperative pain control
Time frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Compare the postoperative opiate consumption measured as the number of tablets taken
Time frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- 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.
Ajay Premkumar, MD principal investigator
Emory University
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 in people with Knee Arthritis, run by Emory University 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 4 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: finished, as of the sponsor's last update on 18 Sep 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Pain Score during Follow up period (time frame: Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery). 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 18 Sep 2025.