Randomised Controlled Double-blind Monocenter Therapy Study Validating the Benefit From Information Provided by Image Free Navigation System on the Precision of the Placement of Acetabular Component in Patients Undergoing Primary THA
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
研究概览
简要总结
This study was initiated to investigate the impact of the computer based image free navigation on the precision of the cup implantation. The implantation of the acetabular component (cup) is known to be a critical step in hip endoprosthetics. The cup position influences significantly the function, the absence of pain and the longevity of the artificial hip joint. The image free navigation system OrthoPilot is used to control the positioning of the cup during surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for primary cementless total hip endoprosthesis implantation with Bicontact stem and Plasmacup
- •Diagnoses: primary or secondary coxarthrosis, rheumatoid arthritis, femoral head necrosis
- •Age ≥ 50 Years
- •ASA score <4
- •Patient signed the informed consent
排除标准
- •Excessive damage to the hip joint (e.g. dysplasia)
- •Severe deformities of the pelvis, femoral bone or knee
- •Unfeasibility of landmark palpation (e.g. due to adiposity)
- •Acute or chronic infection
- •Pregnancy
- •Patients not available for follow-up-examination at the center
- •Patients exceeding 10 mSv effective radiation dose because of previous scientific or clinical exposition during the past 10 years
研究组 & 干预措施
Manual
Manual Implantation of THA
干预措施: Manual Intervention (Procedure)
Navigated
Navigated Implantation of THA
干预措施: Navigated Intervention (Procedure)
结局指标
主要结局
Evaluation of improvement of the implantation accuracy of acetabular component by navigation compared to manual implantation
时间窗: 3 months
The ratio of implantations within the intraoperatively adjusted safe zone of Lewinnek (target anteversion +/-10°, target inclination +/-10°), proved by a CT-scan control measurement.
次要结局
- Comparison of implantation precision, postoperative function and complication rates with vs. without gaining information from navigation system.(3 months)