Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of two postoperative interventions designed to preserve muscle protein after major hip or knee surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Ketoconazole

Criteria

Inclusion Criteria for All Participants:

• Scheduled for surgery because of osteoarthritis, avascular necrosis, fracture, or revision of total joint replacement in the hip or knee

Exclusion Criteria for All Participants:

• Taking insulin, thiazolidinediones (TZD), or metformin

• Kidney insufficiency, as indicated by serum creatinine of more than 2.0 mg/dl

• Recently treated cancer other than basal cell carcinoma

• Any other condition or event that would be considered as reason for exclusion by the study investigators

• Pregnancy

Exclusion Criteria for Experiment 1 Participants:

• Severe hypertension as indicated by requiring more than two drugs for blood pressure control

• History of hypo- or hypercoagulation disorders, including individuals who have taken warfarin (Coumadin)

• Atrial fibrillation, angina, or congestive heart failure

Exclusion Criteria for Experiment 2 Participants:

• Liver disease or abnormal liver function tests

• HIV infected

• Active hepatitis

• Any uncontrolled metabolic disease, including liver or kidney disease

• Taking medications that use the cytochrome P450 pathway for metabolism and unable to discontinue their use for the duration of the study

• Require certain medications. More information on this criterion can be found in the protocol.

• Gastrointestinal absorption disorders that affect nutrient uptake