Orthopedic Miniature Measuring Arm for Assessing Selected Parameters During Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 4
研究概览
简要总结
This multicenter clinical investigation evaluated the NaviFast 6D orthopedic miniature measuring arm during total hip arthroplasty. NaviFast 6D is an intraoperative measuring device intended to help orthopedic surgeons assess changes in lower limb length and hip offset during surgery.
The study was conducted in adult patients undergoing primary total hip arthroplasty. It included two phases. In the first phase, the device was used to verify functionality, usability, and measurement accuracy without influencing surgical decisions. In the second phase, surgeons could use the intraoperative measurements provided by NaviFast 6D when selecting trial and final implant components.
The main objectives were to compare NaviFast 6D measurements with radiographic measurements of limb length change and to compare postoperative leg length discrepancy between patients treated with NaviFast 6D and a control group treated using conventional clinical assessment. The study also assessed the impact of device use on surgical time and recorded device-related and procedure-related safety events.
详细描述
This was a multicenter, controlled, open-label, non-randomized clinical investigation of the NaviFast 6D orthopedic miniature measuring arm in patients undergoing primary total hip arthroplasty.
NaviFast 6D is an active, invasive surgical medical device with a measuring function. The device consists of pelvic and femoral fixation elements, an articulated measuring arm with motion sensors, and a microprocessor unit with a display. It is intended for professional use by orthopedic surgeons during total hip arthroplasty to provide intraoperative information on changes in lower limb length and hip offset relative to the pre-implantation state.
During the procedure, fixation elements were attached to the pelvis and femur using cannulated screws. The measuring arm connected the two fixation elements and recorded relative displacement in six degrees of freedom. A baseline measurement was taken before implantation. After preparation of the acetabulum and femur and placement of trial components, the measuring arm was used again to assess the change in limb length and offset. The surgeon could then consider these measurements before final implantation.
The clinical investigation was conducted in two phases. Phase I focused on verification of device functionality, safety, usability, optimization of the measurement procedure, and comparison of NaviFast 6D measurements with reference radiographic measurements. During Phase I, surgical decisions were based on standard clinical assessment rather than on the device measurements. Phase II evaluated use of the final device configuration in clinical practice, with surgeons allowed to use NaviFast 6D measurements when selecting implant components, unless clinical assessment contradicted the measurement.
The primary objective of Phase I was to determine the accuracy of NaviFast 6D measurements of limb length change and hip offset compared with radiographic reference measurements. The primary objective of Phase II was to compare postoperative leg length discrepancy in patients treated with NaviFast 6D with a control group treated using conventional clinical assessment only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
No masking was used. Surgeons and study personnel were aware of whether NaviFast 6D was used during the procedure.
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for primary total hip arthroplasty.
- •Male or female patients.
- •Age 20 to 85 years.
- •No previous surgical procedures in the affected hip joint.
- •Ability and willingness to provide informed consent for participation in the clinical investigation.
排除标准
- •Lack of informed consent to participate in the clinical investigation.
- •Pregnancy.
- •Femoral neck fracture.
- •Pertrochanteric femoral fracture.
- •Pseudarthrosis of the femoral neck.
- •Traumatic or post-traumatic changes of the proximal femur or acetabular region.
- •Bone neoplasm.
- •Bone infection.
- •Advanced osteoporosis.
研究组 & 干预措施
NaviFast 6D Measuring Arm
Patients undergoing primary total hip arthroplasty with intraoperative use of the NaviFast 6D orthopedic miniature measuring arm. The device was used to measure changes in lower limb length and hip offset during surgery. In Phase I, measurements were recorded but did not guide surgical decisions. In Phase II, surgeons could use NaviFast 6D measurements when selecting trial and final implant components.
干预措施: NaviFast 6D Measuring Arm (Device)
Conventional Clinical Assessment
Patients undergoing primary total hip arthroplasty using conventional intraoperative clinical assessment only, without use of the NaviFast 6D measuring arm. This group served as the control group for comparison of postoperative leg length discrepancy.
干预措施: Conventional Clinical Assessment During Total Hip Arthroplasty (Procedure)