A Prospective Clinical Evaluation of Acetabular Cup Placement in Total Hip Replacements Utilizing a Pelvic Alignment Level (PAL) Instrument
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.
研究概览
简要总结
The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.
详细描述
Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint diseases. However, post operative complications such as dislocations, osteolysis, component wear and migration are still a concern. It has been noted in the scientific literature that precise acetabular cup position helps reduce such post operative complications. The Pelvic Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant position without the need for intra-operative fluoroscopy or a large capital expenditure. The focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral offset, and leg length) of using the PAL instrument to those without using PAL instrument during total hip replacement. This will be a prospective, post market, randomized multi-center clinical study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
- •Patient clinically qualifies for total hip arthroplastic surgery, based on physical examination and medical history.
- •Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or rheumatoid arthritis.
排除标准
- •Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion.
- •Patient has an active infection within the affected hip joint.
- •Patient is a prisoner.
- •Patient has plans to relocate to another geographic area before the completion of the evaluation.
研究组 & 干预措施
Pelvic Alignment Level (PAL)
Pelvic Alignment Level Instrument Used
干预措施: Pelvic Alignment Level (PAL) Instrument (Device)
No Pelvic Alignment Level (PAL)
No Pelvic Alignment Level Instrument Used
干预措施: No Pelvic Alignment Level (PAL) Instrument (Device)
结局指标
主要结局
To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument.
时间窗: 6 week follow-up
次要结局
- To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument.(6 week follow-up)