A 4-way randomized double-blinded migration (RSA), bone density (DXA), and biomarker study assessing adaptive bone changes and implant fixation and longevity of the new Regenerex Porous Titanium Tibial Tray with different adjuvant medical therapies.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Implant migration (RSA) measured continuously from baseline to followup (MTPM) and estimation of Continuous MTPM (MTPM migration > 0.2 mm between 12 and 24 months of follow-up) according to Ryd et al. (Ryd et al., 1995).
研究概览
简要总结
Investigate the possibility to improve immediate and long term fixation of cementless tibial components of total knee arthroplasty by use of adjuvant treatment by denosumab or topical zoledronic acid through assessment of implant migration in relation to the bone by radiostereophotogrammetric analysis (RSA) and assessment of bone mineral density changes in the periprosthetic bone as measured by dual energy x-ray absorptiometry (DXA). H1: Tibial components are more stable (RSA) in the intervention groups receiving active substances (denosumab s.c. injection or topical zoledronic acid) compared to placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •primary knee osteoarthritis in capable men and women
- •sufficient bone quality for total cruxiate retaining knee arthroplasty
- •age above 18 years but maximum 75 years of age
- •informed and written consent
排除标准
- •neuromuscular or vascular disease in the affected leg
- •renal failure (GFR < 30 ml/min)
- •persistent hypocalcaemia
- •allergic to bisphosphonate or denusomab
- •sporadic or permanent need of systemic glucocorticoid treatment
- •active cancer
- •radiation or chemotherapy
- •poor dental status (increased risk of jaw-necrosis with bisphosphonates/denusomab)
- •high use of alcoholic beverages (women > 14, men > 21 units/week)
- •peroperatively found to be unsuitable for a primary knee arthroplasty
- •osteoporosis based on former diagnosis or preoperative DXA-scan
- •fracture sequelae or previous PTO or previous extensive knee surgery
- •need for a stem-elongation
- •NSAID postoperatively
- •pregnancy (positive pregnancy test) or at risk of becoming pregnant during the project (not using safe anti-conceptive agents like contraceptive pills, intra-uterine device (IUD), hormone depot injection, subdermal implantation of a contraceptive rod, hormone vaginal ring, transdermal depot hormone sticking plaster)
- •metabolic bone disease
- •rheumatoid arthritis
结局指标
主要结局
Implant migration (RSA) measured continuously from baseline to followup (MTPM) and estimation of Continuous MTPM (MTPM migration > 0.2 mm between 12 and 24 months of follow-up) according to Ryd et al. (Ryd et al., 1995).
Implant migration (RSA) measured continuously from baseline to followup (MTPM) and estimation of Continuous MTPM (MTPM migration > 0.2 mm between 12 and 24 months of follow-up) according to Ryd et al. (Ryd et al., 1995).
次要结局
- Biomarkers - Bone resorption from baseline to follow-ups and correlation between bone density changes, biomarkers of bone resorption and implant migration
- DXA - Changes in Bone Mineral Density under the Tibial Tray and in proximity of the central stem.
研究者
Department of Orthopedics
Scientific
Region Midtjylland