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临床试验/NCT00738803
NCT00738803Unknown不适用

Restoration of Leg Length, Offset, and Center of Rotation in Total Hip Replacement

Tennessee Orthopedic Alliance2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Leg Length and total offset

研究概览

简要总结

The investigators aim to demonstrate the ability to accurately measure and restore leg length, offset, and center of rotation during a total hip replacement through a new technique that uses the femoral component as a measurement tool. The operative technique requires inserting the femoral component prior to performing the femoral neck osteotomy. After the femoral component is implanted, a reference guide is attached to the femoral component and guides a screw into the ilium at a fixed distance from the femoral component. The pre-arthroplasty measurements of leg length and offset are recorded. The femoral neck osteotomy is performed, and the native femoral head is removed and measured. The acetabular socket is prepared and the acetabular component is inserted. A repeat measurement with trial modular neck components is taken and allows the surgeon an additional opportunity to accurately recreate leg length and offset with the final component. The reference screw is removed from the ilium and the incision is closed.

详细描述

Background:

Leg length inequality following total hip replacement is the leading cause of patient dissatisfaction and subsequent litigation after total hip replacement. A change in the total offset of the hip (lateral translation of the femur relative to the pelvis) may also cause significant discomfort and hip instability. Before surgery, patients are informed that their leg may be lengthened and a shoe lift may be required in the opposite shoe to equalize the leg lengths. Although much less frequent, the leg can accidentally be shortened following total hip replacement. In one recent study, 62% of patients had a mean leg lengthening of 9 mm and one third of these patients complained about this lengthening.

Limb length inequality can occur for two reasons. First, significant inaccuracies exist in current leg length measurement techniques. Second, the surgeon may deliberately lengthen a patient in order to gain hip stability. Increasing leg length and/or hip offset decreases the occurrence of bony impingement and increases myofascial tension, both of which improve hip stability and prevent hip dislocation.

Current methods of determining leg length and offset during surgery include pre-operative templating, intra-operative measurements, intra-operative x-rays, and computer navigated surgery. From the pre-operative x-rays, surgeons typically determine which size implant will best fit the patient's anatomy and best recreate the same leg length. During surgery, surgeons may attempt to palpate both the operative and the contra-lateral knee and/or ankle to estimate leg lengths. Surgeons may measure the length of the femoral head and neck that were removed and the length of the femoral head and neck that were replaced. Surgeons may insert a long pin into the pelvis (typically the ilium bone) and measure the length from this pin to some reference point on the femur. This pin in the pelvis method is probably considered the most accurate, but the leg must be repositioned in exactly the same position for the measurement to be accurate; 5° of hip abduction results in an 8 mm error in leg length.3 An intra-operative x-ray that shows both hips can also help estimate leg length and hip offset. Surgical navigation can determine leg length but is not widely availability and requires a significant financial commitment by an institution. Surgeons typically determine the appropriate amount of hip offset from their pre-operative templating. Current leg length guides have shown even greater errors in their attempts to measure hip offset.

Hypothesis:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

入选标准

  • Hip arthritis requiring a total hip replacement through a superior approach

排除标准

  • Non-english speaking
  • Need for a cemented femoral stem
  • Acute femoral neck fracture

结局指标

主要结局

Leg Length and total offset

时间窗: 2 weeks

次要结局

未报告次要终点

研究者

发起方
Tennessee Orthopedic Alliance
申办方类型
Other

研究点 (2)

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