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临床试验/NCT04591067
NCT04591067已完成不适用

Physical Capacity Among Patients Treated With Periacetabular Osteotomy for Hip Dysplasia: a Cross-sectional Study

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6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
40
试验地点
1
主要终点
Gait function

研究概览

简要总结

This cross-sectional study investigates the physical capacity of patients, who have undergone a periacetabular osteotomy for hip dysplasia within the last 1-5 years.

详细描述

Hip dysplasia is a common disease both worldwide and among the Danish population. The disease is characterized by a shallow and oblique acetabulum, resulting in insufficient coverage of the femoral head. The abnormalities of the dysplastic hip joint lead to altered biomechanical adaptations, highly affecting the physical capacity of patients. Studies have shown that patients with hip dysplasia experience reduced muscle strength and gait abnormalities, when compared to healthy controls.

Each year, approximately 200 Danes with hip dysplasia are treated with periacetabular osteotomy (PAO). As the preferable joint-preserving surgical treatment for younger patients with symptomatic hip dysplasia, the PAO reduces prevalence of muscle-tendon-related pain and improves hip and groin related patient-reported outcome measures (PROMs). By extension, studies report a hip survival rate of approximately 75% 12 years following PAO.

However, little is known about objective measures of physical capacity following PAO. Despite reducing muscle-tendon-related pain and improving PROMs, gait adaptations still remain and studies report no improvements in muscle strength, nor in the physical activity profile, 1 year following treatment with PAO. Thus, the field calls for research aiming to identify parameters of impaired physical capacity in patients treated with PAO. Thorough knowledge of physical capacity in these patients may contribute to the establishment of a science-based rehabilitation strategy, potentially improving physical activity, function, work capacity and quality of life.

The primary aim of this study is to analyse and identify parameters of impaired physical capacity in patients with hip dysplasia 1-5 years following treatment with PAO. Gait function, defined as peak hip extension angle and peak hip flexor moment, is chosen as the primary outcome, due to previously shown correlations between the extent of gait impairments and the Copenhagen Hip and Groin Outcome Score (HAGOS).

As recommended by the International Hip-related Pain Research Network (IHiPRN), measurements of physical capacity in patients with hip-related pain should include: clinical measures, laboratory-based measures, measures of physical activity and return to physical activity. Secondary outcomes of this study are: muscle activity during level walking and walking with inclination, endurance and pain during walking, range of motion (ROM), muscle strength, hip and muscle-tendon-related pain, radiographic measures and PROMs (present level of physical activity and sports & activity level prior to and after treatment with PAO).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 40 years
  • BMI < 30
  • Primary diagnosis of ipsilateral or bilateral hip dysplasia
  • Treated with PAO for hip dysplasia unilaterally or bilaterally within 1-5 years

排除标准

  • Retroverted acetabulum (positive posterior wall sign and ischial spine sign) treated with reversed PAO
  • Total Hip Arthroplasty (THA)
  • Pain management with analgesics or other medication affecting muscle function and perception of pain
  • A need for walking aids to be able to walk freely

结局指标

主要结局

Gait function

时间窗: Baseline

Peak hip extension angle and peak hip flexor moment

次要结局

  • Maximal voluntary isometric hip muscle force(Baseline)
  • Gait function following fatigue(Baseline)
  • Hip specific patient reported outcome measures (PROMs)(Baseline)
  • Hip and muscle-tendon-related groin pain(Baseline)
  • Muscle activity(Baseline)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sally Oppendieck Andersen

MSc. Human Physiology, BSc. Exercise & Sport Sciences

Copenhagen University Hospital, Hvidovre

研究点 (1)

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