A Study in Older Patients Undergoing Elective Total Hip Replacement

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Males or females age 60 years or older.

Elective total hip arthroplasty (eTHA) is scheduled.

Have a body mass index of <40 kg/ m² and a weight <136.4 kg.

Can climb at least 6 stairs with or without holding the handrail (but without human assistance), according to the patient at the screening visit.

Can stand up from a chair and walk more than 10 meters without human assistance

Take at least 12 seconds to perform the Timed Up and Go (TUG) test at the screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

1. Another inpatient surgical procedure is planned in the 6 months following the randomization visit.
2. Lower extremity amputation.
3. Lower limb fracture within 6 months prior to the screening visit.
4. Simultaneous bilateral eTHA.
5. The planned surgical procedure will preclude weight bearing for at least 4 weeks postoperatively (for instance, the planned procedure will involve extensive bone grafting). ?Partial weight bearing? and ?weight bearing as tolerated? are acceptable, but ?non weight-bearing,? ?touch weight bearing,? or ?feather weight bearing? are exclusive.
6. Underlying muscle disease (for example, polymyositis or muscular dystrophy) or a history of muscle disease other than age-associated muscle waste or disuse atrophy.
7. Recent neurologic injury (<6 months prior to randomization) such as stroke or spinal cord injury, or unstable neurologic disorders that are likely to confound physical performance tests during the course of the study (such as unstable Parkinson disease or hemiplegia).
8. History of positive testing for human immunodeficiency virus (HIV).
9. Current us or previous us of any substances known to influence muscle mass or performance within 6 months prior to randomization (this includes anabolic steroids, replacement therapy for gonadal deficiency, growth hormone, IGF1, or any other agent used to build muscle mass), or systemic corticosteroid use for at least 3 months prior to randomization at a daily dose ?10 mg prednisone equivalent.
10. Severe Vitamin D deficiency defined as 25-hydroxy-vitamin D levels <9.2 ng/mL or <23 pmol/mL at the screening visit.
11. History of a malignant neoplasm in the 5 years prior to the screening visit, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to screening may enter the study.
12. History of any of the following conditions within 90 days of the screening visit: Unstable angina, myocardial infarction, coronary artery bypass graft surgery, or percutaneous coronary intervention (eg, angioplasty or stent placement).
13. Any current supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 beats per minute) at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for 30 seconds) despite medical or device therapy, or any history of resuscitated cardiac arrest or the presence of an automatic internal cardioverter-defibrillator.
14. Any history of congestive heart failure within 6 months of the screening visit.
15. Systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at screening visit (if stress is suspected, retest under basal conditions), or malignant hypertension.
16. An abnormality in the locally read 12-lead electrocardiogram (ECG) that in the opinion of the investigator increases the risk of participating in the study or a Bazett?s corrected QT interval >450 milleseconds for men and >470 milleseconds for women.
17. Have either or both of the following: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal (ULN), or alkaline phosphatase >1.5 times ULN, or total bilirubin >1.5 times ULN. The liver tests above may be repeated once within a week if the initial response exceeds this limit, and the l

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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