Medrol Dosepak Taper for Delayed Post-op Recovery After TKA

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of a methylprednisolone taper on patients with decreased range of motion (ROM) or delayed recovery in the acute postoperative period following total knee arthroplasty (TKA).

Patients with decreased ROM or delayed recovery six weeks to three months post-TKA will improve ROM and patient-reported outcomes at two weeks post-treatment initiation of methylprednisolone taper, as compared to similar patients who receive a placebo taper.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Any patient undergoing primary TKA with a diagnosis of osteoarthritis

• ≥ 18 years old

• ROM <90° by 3 weeks postoperatively without improvement to >90° by 6 weeks

• Requiring a 30-pill oxycodone refill

• NSAID allergy

• Thigh circumference discrepancy >2cm between legs from 3 to 6 weeks

• Defense and Veterans Pain Rating Scale (DVPRS) > 5 between 3 and 6 weeks

• Willingness to undergo randomization

Exclusion Criteria:

• Reported chronic corticosteroid or opiate use

• Suspected or confirmed periprosthetic joint infection

• Revision TKA

• Primary diagnosis other than osteoarthritis, including avascular necrosis, fracture, or post-traumatic arthritis

• American Society of Anesthesiologists (ASA) score ≥ 4

• Reported history of liver or renal disease

• Uncontrolled diabetes

• Immunosuppression

• ≤ 18 years old

• Inability to take oral medications

• Unable to provide consent