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临床试验/NCT04748458
NCT04748458已完成不适用

Retrospective Study About the Long-term Outcomes of Conical Tapered Stems in Cementless Total Hip Arthroplasty for Osteoarthritis Due to Congenital Hip Pathologies

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
85
试验地点
1
主要终点
Radiographic Stem Osseointegration

研究概览

简要总结

A retrospective consecutive population of patients treated with conical tapered stems in cementless total hip arthroplasty for osteoarthritis due to congenital hip pathologies will be selected. The aim of this retrospective study is to evaluate the long-term clinical and radiographic results of this implant and the survival rates in such a specific cohort.

详细描述

Congenital hip pathologies may severely alter the local anatomy of the hip, making total hip arthroplasty (THA) due to osteoarthritis after congenital hip pathologies challenging. While it seems that congenital hip pathologies did not significantly influence the outcomes when compared to THA after osteoarthritis, the choice of implant was demonstrated to impact the survival rates of the THA after congenital hip pathologies.

To date, no guidelines exist about the correct choice of hip implant in congenital hip pathologies: only mid-term case series are available. Conical tapered stems have been frequently suggested for the most difficult cases.

The aim of this study is to describe the survival rates and the long-term clinical and radiological outcome of conical tapered stems in THAs after congenital hip pathologies.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Symptomatic hip osteoarthritis due to congenital hip pathologies
  • Consecutive population with a minimum follow-up of 2 years
  • Cementless total hip arthroplasty with conical tapered stem
  • Pre-operative planning using CT
  • Complete clinical and radiographic assessment

排除标准

  • Other type of hip osteoarthritis
  • Other type of implants
  • Inadequate pre-operative planning (eg: no CT)
  • Incomplete clinical and radiographic assessment

结局指标

主要结局

Radiographic Stem Osseointegration

时间窗: 15 months

Osseointegrated stems described according to Engh's criteria

Harris Hip Score

时间窗: 15 months

Mean clinical results at last follow-up evaluated using the Harris hip score. Minimum-maximum values: 0-100. Best result: 100.

Radiographic Cup Osseointegration

时间窗: 15 months

Osseointegrated cups described using the Moore's criteria: the cup is osseointegrated when at least 3 criteria are present (radial trabeculae, superolateral buttress, inferolateral buttress, medial stress shielding, absence of radiolucent lines).

Survival Rate

时间窗: 15 months

Percentage of survived implants (no component exchange or removed) described using Kaplan-Meier curve with 95% confidence interval. Minimum-maximum values: 0-100. Best result: 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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