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临床试验/NCT04653090
NCT04653090已完成不适用

Varus Stem Positioning Does Not Affect Long-term Functional Outcome in Cementless Anatomical Total Hip Arthroplasty.

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 283 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
283
试验地点
1
主要终点
Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.

研究概览

简要总结

Varus positioning is the most common femoral malposition in total hip arthroplasty (THA). The aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment.

详细描述

Data were prospectively collected and retrospectively reviewed for all patients who received a cementless anatomical femoral stem in THA between 1998 and 2008. After exclusion criteria applied, 127 stems had an varus axis deviated by more than 3 degrees (varus group) and 156 had an alignment between 0 and 2.9° from the femoral axis (neutral group). Survivorship rates, complications, clinical scores, thigh pain, radiological score, cortical hypertrophy and filling rate were analyzed. Mean follow-up was 10 years.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • All patients received by several senior surgeons, the same standardized posterolateral total hip arthroplasty, and the same rehabilitation protocol.

排除标准

  • Etiologies other than osteoarthritis (osteonecrosis, fracture, dysplasia, rheumatoïd arthritis),
  • Complex cases with additional procedure,
  • Dual-taper modular or cemented stem,
  • Incomplete preoperative data or less than one-year postoperative data.

结局指标

主要结局

Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.

时间窗: Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.

Kaplan-Meier survivorships free of revision of the femoral component for any reason, femoral fracture and revision of femoral component for fracture were calculated and compared by log-rank test for both group.

次要结局

  • Long-term clinical outcomes with varus or neutral femoral stem.(Clinical evaluation was carried out through study completion at an average of 10 years by the surgeon.)
  • Long-term radiological outcomes with varus or neutral femoral stem.(Radiological evaluation was carried out through study completion at an average of 10 years by the surgeon.)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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