Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.
This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
62
Chang Gung Memorial Hospital
Kweishan, Taoyuan, Taiwan
bone mineral density [g/cm2] of the 7 Gruen zones
bone mineral density measured by dual energy x-ray absorptiometry
Time frame: 5 years
bone mineral density change relative to the baseline values of the 7 Gruen zones
bone mineral density measured by dual energy x-ray absorptiometry
Time frame: 5 years
implant loosening or migration
check the implant position by serial standard X ray follow-up
Time frame: 5 years
serum alkaline phosphatase
Time frame: 5 years
serum calcium level
Time frame: 5 years
serum phosphate level
Time frame: 5 years
serum osteocalcin level
Time frame: 5 years
serum N-telopeptide procollagen level
Time frame: 5 years
serum creatinine level
renal function and glomerular filtration rate
Time frame: 5 years
serum alanine aminotransferase level
liver function
Time frame: 5 years
serum aspartate aminotransferase level
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liver function
Time frame: 5 years
harris hip score
hip function measurement
Time frame: 5 years
short form-12
life quality measurement
Time frame: 5 years
University of California Los Angeles Activity Score
functional and activity evaluation, 10 point scale
Time frame: 5 years