Radiographic Migration Analysis of the Insignia Hip Stem
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Migration
研究概览
简要总结
The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.
详细描述
This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.
The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty - Aged 21 years or older
- •Patients willing and able to comply with follow-up requirements and self-evaluations
- •Ability to give informed consent
排除标准
- •Active or prior infection
- •Medical condition precluding major surgery
- •Medical condition with less than 2 years life expectancy
- •Overhanging pannus (direct anterior approach)
- •Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
- •Skin condition on the area of incision
- •Multi-level lumbar spine fusion
- •Ankylosing spondylolithesis
- •Shortening osteotomy through the femur
结局指标
主要结局
Migration
时间窗: Up to 2 years post-operative
Quantify migration of the Insignia stem using RSA and CT-RSA
次要结局
- Validation(Up to 2 years post-operative)
- Early migration(Up to 2 years post-operative)
- Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year(Up to 2 years post-operative)
- Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year(Up to 2 years post-operative)
- Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year(Up to 2 years post-operative)