Prospective Evaluation of Biomarkers Variability in Knee Prosthetic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in biomarkers serum level after surgery
研究概览
简要总结
Bone quality is an important factor influencing the outcome of total knee replacement (TKR) surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the choice of the most appropriate prosthetic implant.
The primary goal of this study is to measure serum and tissue levels of some proteins involved in bone remodelling.
详细描述
Aseptic implant loosening after TKR causes knee pain, reduces knee function and may require revision surgery.
Several proteins have been identified, which are involved in bone metabolism and remodelling; variations in serum levels of some of these proteins after TKR loosening have also been described.
However, preoperative identification of risk factors for aseptic loosening remains a challenge.
An observational study is conducted to evaluate how levels of the following serum biomarkers vary after TKR:
- osteoprotegerin (OPG)
- receptor activator of nuclear factor kappa-B (RANK)
- receptor activator of nuclear factor kappa-B ligand (RANK-L)
- sclerostin
- cathepsin K
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 40, <80
- •Indication for TKR
- •Surgical indication for PFC Sigma®, posterior stabilized, mobile bearing TKR
- •Patients signed written informed consent
排除标准
- •Age > 80, < 40
- •TKR revision surgery
- •Fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope.
- •Knee ankylosis
- •Paget's disease
- •Hyperparathyroidism
- •Patient treated with: bisphosphonates, strontium ranelate, selective estrogen receptor modulators for osteoporosis, calcitonin, denosumab.
- •Informed consent not accepted
- •Serious comorbidity
- •Active infections
- •Pregnant or breastfeeding women
结局指标
主要结局
Change in biomarkers serum level after surgery
时间窗: One day before surgery; 3 months after surgery and 12 months after surgery
OPG, RANK, RANK-L, sclerostin, cathepsin K, CTP1 and P1NP levels will be assessed on blood samples. CRP, IL-1, IL-6, TNF-α and ESR will also be measured to identify inflammatory states.
次要结局
- Change in periprosthetic bone density after surgery(3, 6, 12 months after surgery)
- Biomarkers mRNA expression(Baseline)
研究者
Pietro Randelli, MD
Assistant Professor
University of Milan