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临床试验/NCT02399670
NCT02399670已完成不适用

The Influence of Global Femoral-offset Changes After Total Hip Arthroplasty on Function, Quality of Life and Abductor Muscle Strength: a Prospective Cohort Study

Sundsvall Hospital0 个研究点目标入组 222 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
222
主要终点
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

研究概览

简要总结

The femoral-offset (FO) is one of the important perioperative parameters in THA. A prospective cohort study was conducted between September 2010 and December 2013. All patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded. Global FO was measured in each patient within 3 months before the THA and at the second postoperative day using a standardized protocol. According to the postoperative measurement, patients were divided into three groups: 1) the decreased FO group, where the FO of operated side was reduced more than 5mm compared with the contralateral side, 2) the restored FO group, where the FO of operated side was within 5mm restored compared with the contralateral side, and 3) the increased FO group, where the FO of operated side was increased more than 5mm compared with the contralateral side.

Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and EQ-5D questionnaires in addition to a clinical assessment with palpation of the operated hip and measurement of the abductor muscle strength.

详细描述

The results of total hip arthroplasty (THA) have shown great improvement during the last decades in terms of function, quality of life and prosthetic survival. Beside pain relief, surgeons aim to position the stem and cup in a correct manner to restore the biomechanical forces and range of motion of the operated hip. The femoral-offset (FO) is one of the important perioperative parameters in THA. A prospective cohort study was conducted between September 2010 and December 2013. All patients with unilateral primary osteoarthritis (OA) treated with THA were considered for inclusion. Patients with secondary OA, previous spinal, pelvic, or lower limb injuries or fractures were excluded. Global FO was measured in each patient within 3 months before the THA and at the second postoperative day using a standardized protocol. According to the postoperative measurement, patients were divided into three groups: 1) the decreased FO group, where the FO of operated side was reduced more than 5mm compared with the contralateral side, 2) the restored FO group, where the FO of operated side was within 5mm restored compared with the contralateral side, and 3) the increased FO group, where the FO of operated side was increased more than 5mm compared with the contralateral side.

Patients were followed-up at 12 - 15 months postoperatively with self-administered WOMAC and EQ-5D questionnaires in addition to a clinical assessment. Patients completed an additional questionnaire enquiring about any residual problems with the use of walking aid and residual pain around the operated hip. During the clinical assessment, palpation of the operated hip and measurement of the abductor muscle strength were undertaken.

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 primary osteoarthritis treated with total hip arthroplasty

排除标准

  • Secondary osteoarthritis
  • Previous spinal, pelvic or lower limb injuries or fractures
  • Bilateral osteoarthritis

结局指标

主要结局

Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index

时间窗: 12 months

Patient reported functional outcome

次要结局

  • VAS scale(12 months)
  • EQ-5D(12 months)
  • Hip abductor muscle strength(12 months)

研究者

发起方
Sundsvall Hospital
申办方类型
Other
责任方
Sponsor

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