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临床试验/NCT07630519
NCT07630519已完成不适用

Comparative 3D Gait Analysis: Impact of Total Hip Arthroplasty Stem Anchoring (Metadiaphyseal vs Metaphyseal)

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
3D Gait analysis - Gait Profile Score

研究概览

简要总结

Patients with hip osteoarthritis who were indicated for total hip arthroplasty were prospectively enrolled and randomized to receive either a short (metaphyseal) stem or a conventional (metadiaphyseal) stem hip arthroplasty. Three-dimensional gait analysis was performed regularly (preoperatively and at multiple postoperative time points) to determine whether conservative implants result in superior objective and patient-reported outcomes

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, Care Provider)

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •high-grade hip osteoarthritis

排除标准

  • 未提供

研究组 & 干预措施

Conservative (metaphyseal) stem hip arthroplasty

Active Comparator

Hip arthroplasty is performed through a minimally invasive anterolateral hip approach. All replacements are completely non-cemented, articulations include polyethylene or ceramic inserts on ceramic heads. Cups are standardly fixed through press-fit principle, no additional pelvis screws were standardly used. Special curved femoral reamers are used in order to consume as little bone stock as possible (only the metaphysis) and provide a muscle-sparing approach.

干预措施: Conservative Total Hip Arthroplasty (Procedure)

Conventional (metadiaphyseal) stem hip arthroplasty

Active Comparator

Hip arthroplasty is performed through a minimally invasive anterolateral hip approach. All replacements are completely non-cemented, articulations include polyethylene or ceramic inserts on ceramic heads. Cups are standardly fixed through press-fit principle, no additional pelvis screws were standardly used. Standard femoral preparation is performed with prosthesis taking bone stock from the metadiaphyseal area of proximal femur, however, gluteal insertions were preserved in simillar fashion as in metaphyseal implants.

干预措施: Conventional Total Hip Arthroplasty (Procedure)

结局指标

主要结局

3D Gait analysis - Gait Profile Score

时间窗: from preoperative to 1 year postoperative

The Gait Profile Score (GPS) is a numerical index (range 0-10, the lesser the number, the better for the patient). The GPS comprises of the kinematic parameteres that are also called the Gait Variable Scores (hip flexion, rotation and abduction) and the spatiotemporal parameters (step time, step length and step cadence). All of these parameters are also mentioned ad separate outcome measures. The extraction of GPS from the 2 basic data groups was done automaticaly through specialised software which is based on the work of Baker et al. (Baker R, McGinley JL, Schwartz MH, et al. The gait profile score and movement analysis profile. Gait Posture. 2009;30(3):265-269. doi:10.1016/j.gaitpost.2009.05.020).

次要结局

  • The Modified Harris Hip Score(from preoperative to 1 year postoperative)

研究者

发起方
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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