Assessment of Bone Mineral Density at the Interface With the Femoral and Tibial Components in Patients Undergoing Total Knee Prosthesis of Different Design and Material
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Periprosthetic bone mineral density measurement
研究概览
简要总结
compare changes in BMD via DXA at the level of the femoral and tibial periprosthetic bone between two groups of patients undergoing cemented TKA of different design (posterior stabilization vs posterior cruciate preservation) with proms at a 2-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 45 years
- •Patients who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
- •to. Primary or secondary osteoarthritis b. Collagen disorders and/or avascular necrosis of the femoral condyle c. Moderate valgus, varus or flexion deformities (HKA within ±10°, flexion contracture <10°)
- •Patients consenting and able to complete planned study procedures and follow-up assessments
- •Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee.
排除标准
- •Patients aged < 45 years;
- •Patients who have already undergone hip or knee arthroplasty ankle, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases. In this way, homogeneity of the investigated cohort will be guaranteed;
- •Pregnant women. -
结局指标
主要结局
Periprosthetic bone mineral density measurement
时间窗: 24 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
时间窗: at baseline (day 0)
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
时间窗: 6 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
Periprosthetic bone mineral density measurement
时间窗: 12 months
measurement of periprosthetic bone mineral density using dual-energy x-ray absorptiometry
次要结局
- Western Ontario and McMaster Universities Arthritis Index(24 months)
- Knee Society Score(24 months)
- Knee injury and Osteoarthritis Outcome Score(24 months)
- 36-Item Short Form Health Survey(24 months)
- Knee Society Score(at baseline (day 0))
- Knee Society Score(6 months)
- Knee Society Score(12 months)
- Western Ontario and McMaster Universities Arthritis Index(at baseline (day 0))
- Western Ontario and McMaster Universities Arthritis Index(6 months)
- Western Ontario and McMaster Universities Arthritis Index(12 months)
- Knee injury and Osteoarthritis Outcome Score(at baseline, (day 0))
- Knee injury and Osteoarthritis Outcome Score(6 months)
- Knee injury and Osteoarthritis Outcome Score(12 months)
- 36-Item Short Form Health Survey(at baseline (day 0))
- 36-Item Short Form Health Survey(6 months)
- 36-Item Short Form Health Survey(12 months)
研究者
Stefano Zaffagnini
professor
Istituto Ortopedico Rizzoli