Prosthetic Fixation After Cementless Total Hip Arthroplasty
Conditions
Keywords
prosthetic fixation
Brief summary
It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.
Detailed description
To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry （RSA）in two-year follow-up period . Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry（RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA）scans, et al.
Interventions
DRUGZoledronic acid 5mg
two-year Zoledronic acid 5mg infusion treatment
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T\<-2.5;or with previous fragility fracture, bone mineral density T -2.5\ -1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.
Exclusion criteria
1. Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease; 2. Patients who suffer from secondary osteoporosis 3. Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium; 4. Patients with contraindications for Zoledronic acid: 5. Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated; 6. Patients with primary hyperparathyroidism. 7. Serum calcium \>2.75mmol/L (11.0mg/dL). 8. Patients who are unwilling to accept the treatment of Zoledronic acid. 9. Patients who accepted the treatment of investigational product and/or device in the 30 days before randomization. 10. Patients with any medical or mental diseases, which prevent patients from complying with protocols or completing protocols, judged by investigators. 11. Patients with the medical history of inflammation of the iris or uveitis, except the inflammation which is secondary to trauma and cured 2 years ago before screening. 12. Patients with the medical history of diabetic nephropathy or diabetic retinopathy. 13. Patients aged under 60 years old and whose result of urine pregnancy test paper is positive. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the transverse translation (μm) | baseline and month12,month 24 | the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| average bone mineral density ( BMD ) | 1w,6m,12m and 24m after THA operation | the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry （DXA）scans. |
Countries
China
Outcome results
None listed