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临床试验/NCT02102334
NCT02102334已完成不适用

Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty

Sundsvall Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Leg Length Discrepancy

研究概览

简要总结

In total hip arthroplasty (THA), radiographic preoperative planning and postoperative evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD) require good validity, interobserver reliability and intraobserver reproducibility.

Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and anteversion.

90 patients with primary unilateral osteoarthritis (OA) were included in this prospective study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD, acetabular cup inclination and anteversion were measured. The interobserver reliability and intraobserver reproducibility were made by three independent observers. The validity and degree of prediction of Sundsvall method are measured by comparing its results with the standard method.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • unilateral total hip replacement with either a cemented Lubinus SP II system (Link, Germany) or an uncemented CLS stem and Triology cup (Zimmer, U.S.A).

排除标准

  • Patient with secondary (OA), previous spinal, pelvic, or lower limb injuries or fractures were excluded.

结局指标

主要结局

Leg Length Discrepancy

时间窗: 1 week

LLD on radiographs was defined as the difference in perpendicular distance in millimetres between a line passing through the lower edge of the teardrop points to the corresponding tip of the lesser trochanter. The interobserver reliability was assessed from the measurements made by three independent observers.

Femoral offset (Sundsvall method)

时间窗: 1 week

Measurement of FO using the Sundsvall method was carried out on the AP view of the pelvis as the horizontal distance (parallel to Hilgenreiners line) between the femoral axis (a line drawn through the center of the femoral shaft) and the mid line of the pelvis, at the height of the lateral tip of the greater trochanter. The measurement was performed bilaterally to compare the femoral offset on the operated side to the non-operated hip. The interobserver reliability was assessed from the measurements made by three independent observers.

Femoral offset (standard method)

时间窗: 1 week

Measurement of FO with the standard method was carried out on AP view as the addition of the distance between the longitudinal axis of the femur to center of femoral head and the distance from the center of the femoral head to a perpendicular line passing through the medial edge of the ipsilateral teardrop point of the pelvis. The measurement was repeated bilaterally to compare the FO of the operated side to non-operated hip. The interobserver reliability was assessed from the measurements made by three independent observers.

Cup inclination

时间窗: 1 week

Cup inclination was measured on AP view as angle in degrees, between a line drawn along the angle of rim of the cup and trans-ischial line (a line drawn between the most inferior point of the ischial tuberosities). The interobserver reliability was assessed from the measurements made by three independent observers.

Acetabular cup anteversion

时间窗: 1 week

Acetabular cup anteversion was measured on lateral radiograph as the angle formed by the intersection of a line drawn across the face of acetabulum and a line perpendicular to the horizontal plane, according to the Woo and Morry method. The interobserver reliability was assessed from the measurements made by three independent observers.

次要结局

未报告次要终点

研究者

发起方
Sundsvall Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lennart Bråbäck

MD, PhD

Sundsvall Hospital

研究点 (1)

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