Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?
Condition: Osteoarthritis; Post-traumatic; Arthrosis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Prior to surgery, a pharmacist will randomly assign participating patients to one of two
      groups. One group will get an injection in the knee during surgery that contains medications
      to limit pain and an antibiotic. A second group will get an injection in the knee during
      surgery that contains the same pain medications and antibiotic along with a corticosteroid to
      control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused
      with muscle-building anabolic steroids you may have heard about in the news. Each patient
      will have an equal chance of being in either of the two groups. This study will test the
      safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation
      following total knee replacement.
    

Detailed description: 
      Information collected during your office visits:

      The patient will be asked for a brief medical history so that we may determine if the patient
      can participate in the study. A member of our research team will ask the patient a series of
      questions about his/her knee. The patient will be asked to answer this series of questions a
      total of 4 times over the course of 1 year. Also, we will record how well the patient can
      bend and straighten your knee at these 4 office visits. We will have the patient rate the
      pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the
      patients have any complications, those will also be recorded. The patient will also have
      X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine
      following total knee replacement. The X-rays will be read by the surgeon to help determine
      the success of the surgery.

      Injection during total knee replacement surgery:

      All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine,
      clonidine, cefuroxime, and normal saline that will be placed directly into the knee during
      surgery. In addition, approximately half of the patients in the study will also receive
      methylprednisolone acetate as part of the injection.

      Information being collected during your hospital stay:

      During the hospital stay, information will be gathered for this study. A physical therapist
      will measure how well the patient can bend and straighten the knee. The amount of pain
      medication that was taken at the hospital will be recorded, and the number of days spent in
      the hospital will also be recorded.
    

Intervention name(s): methylprednisolone acetate; active comparator
Intervention type(s): Drug; Drug
Intervention description(s): Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate; bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline
Other intervention name(s): bupivacaine HCl; morphine; epinephrine; clonidine; cefuroxime; normal saline
Intervention MeSH terms: Cefuroxime; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Clonidine; Epinephrine; Morphine; Bupivacaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: arthroplasty; replacement; knee