Phase 2
Completed N=40
Effectiveness of Two Types of Treatment in Restoring Muscle After Hip or Knee Surgery
Hip Fracture · Osteoarthritis · Femur Head Necrosis
Source: ClinicalTrials.gov NCT00393848 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2014
Primary outcomePrimary: Muscle Protein Synthesis — 1.38; 0.84; 1.42; 1.36 %/d
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.
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 | — |
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. Informational only — not medical advice.