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临床试验/NCT02970253
NCT02970253已完成1 期

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention

ZOL2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
ZOL
入组人数
190
试验地点
2
主要终点
Clinical data will be measured with scoring list HHS (Harris Hip Score).

研究概览

简要总结

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention.

Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • primary THA

排除标准

  • neurologic disease
  • painful contralateral THA
  • severe back or knee pain
  • rheumatology

结局指标

主要结局

Clinical data will be measured with scoring list HHS (Harris Hip Score).

时间窗: One year

Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score).

Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).

时间窗: One year

Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).

Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).

时间窗: One year

Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score).

Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).

时间窗: One year

Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score).

次要结局

未报告次要终点

研究者

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

Jens Vanbiervliet

Resident Orthopedic Surgery

ZOL

研究点 (2)

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