Knee Arthritis Clinical Trial
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility | Inclusion Criteria: - Patients undergoing primary total knee arthroplasty for osteoarthritis of the knee. - Patients of the ages of 18 and 95 years. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Emory Musculoskeletal Institute | Atlanta | Georgia |
United States | Emory University Orthopaedics & Spine Hospital | Tucker | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery | |
Primary | 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. | Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery | |
Secondary | 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 | 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 | |
Secondary | 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. | Day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery | |
Secondary | 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. | Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery | |
Secondary | 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. | Immediately after the surgery, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 post-surgery |
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