Phase 2
N=40
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
Hip Fracture · Osteoarthritis · Femur Head Necrosis
Bottom Line
View on ClinicalTrials.gov: NCT00393848 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2014
Primary outcome: Primary: Muscle Protein Synthesis — 1.38; 0.84; 1.42; 1.36 %/d
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Essential amino acid supplement (Drug); Ketoconazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Muscle Protein Synthesis |
1.38; 0.84; 1.42; 1.36; 1.23; 1.49 | — |
| SECONDARY Change in Maximal Voluntary Contraction |
0.68; 0.34 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00393848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.