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Corticosteroid
Medrol Dosepak Taper for Delayed Post-op Recovery After TKA
Phase 4
Waitlist Available
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre treatment
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
Summary
This trial will evaluate whether or not a methylprednisolone taper can improve range of motion or delayed recovery in patients six weeks to three months post-TKA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Range of Motion in Degrees at Pre and Post Treatment
Secondary study objectives
Adverse Events or Outcomes Outside of Manipulations Under Anesthesia
Number of Participants With Complications Following Treatment
Patient Reported Outcome Measures: Overall Assessment of Knee 6 Weeks After Treatment
+8 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Methylprednisolone taperActive Control1 Intervention
21 x 4mg tablets at 6 weeks, qualifying for MUA if ROM \<90° at 8 weeks
Group II: Placebo taperPlacebo Group1 Intervention
21 sugar tablets at 6 weeks with standard management, qualifying for MUA if ROM \<90° at 8 weeks
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
439 Previous Clinical Trials
250,242 Total Patients Enrolled