Status:
COMPLETED
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Hip Fracture
Osteoarthritis
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
Brief 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.
Detailed Description
Hip fractures among the elderly are a major health concern. Nearly one-third of elderly hip fracture patients die within 1 year of the injury. Events surrounding the actual injury and any necessary su...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00393848
Start Date
October 1 2006
End Date
October 1 2012
Last Update
June 2 2014
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205