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临床试验/NCT02306525
NCT02306525已完成不适用

Outcome After Arthroscopic Treatment of Patients in Horsens and Aarhus With FemoroAcetabular Impingement: the HAFAI-cohort

University of Aarhus3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
3
主要终点
Hip and pelvis kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and drop jump

研究概览

简要总结

Purpose: The aim of this prospective cohort is to evaluate patients before, 6 and 12 months after arthroscopic surgery for FAI and compare the results to people without hip problems.

Methods/design: Sixty patients with FAI and 30 persons without hip problems will be included. Pre- and postoperatively, patients will be evaluated by CT-scans. All participants will have their hip flexor and extensor muscle strength assessed and have performed kinetic and kinematic analyses of daily activities with 3D motion capture. Further, self-reported questionnaires on hip related pain, quality of life and sports activities will be collected. Finally, participants will have their daily physical activity monitored with tri-axial accelerometers for five consecutive days.

Perspectives: With this prospective cohort study the outcome of arthroscopic treatment of FAI within one year after surgery will be evaluated. If the patients fail to reach reference values one year after surgery, altered surgical procedures or rehabilitation programs to optimize treatment for the patients may be explored in future studies. Further, the investigators expect to perform long-term follow up to evaluate reoperations, conversions to total hip arthroplasty and development of osteoarthritis for the patients surgically treated for FAI.

详细描述

Introduction Femoral acetabular impingement (FAI) is caused by an abnormality in the acetabular shape or orientation (Pincer-type) by a shape abnormality in the proximal femur (Cam-type) or by a mix of the two conditions. FAI causes repeated minor damage to the labrum and edge of the acetabulum. The damage to the joint is proposed to lead to early osteoarthritis (OA) of the hip, but whether FAI is a cause or result of OA is discussed. Surgery can reduce symptoms caused by Cam or Pincer impingement and may prevent future damage to the hip joint. However, different surgical techniques are used, and only few long-term studies of the surgery exist. The latest reviews conclude that 1) the effectiveness of the surgery is not clear, 2) it is not clear how surgery affects functional performance for the patients and 3) it is unknown how surgery for FAI affects the patients in a long-term perspective.

Material and methods

Patients:

Inclusion criteria

  • Planned hip arthroscopic treatment at Horsens Regional Hospital by Consultant Bent Lund
  • A diagnosis of CAM and/or pincer impingement
  • For patients with Cam, an alpha angle > 55 degrees on an anterior/posterior (AP) standing radiograph
  • For patients with Pincer a center edge angle > 25 degrees on an AP radiograph
  • No signs of retroversion in the lower 2/3 of the hip joint on an AP radiograph
  • No posterior wall sign on an AP radiograph
  • Osteoarthritis grade 0-1 according to Tönnis' classification
  • Lateral Joint space width of > 3 mm
  • Age between 18 and 50 years

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hip and pelvis kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand and drop jump

时间窗: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

Hip and pelvis kinetics and kinematics are measured with a 3D motion capture system with a force platform using a standardized protocol

Hip extensor and flexor maximal muscle strength during isometric and isokinetic contractions

时间窗: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

Hip extensor and flexor maximal strength is measured with an isokinetic dynamometer using a standardized protocol

Objectively measured daily physical activities during five days

时间窗: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

Physical activity is measured with a tri-axial accelerometer during a period of 5 days on the following categories: rest, standing, walking, sit to stand, cycling and high impact activity.

Hip-related self-reported health

时间窗: Change from preoperatively (Approx. in the time frame 0-10 weeks before surgery) to one year after surgery

Hip related health is measured with the Copenhagen Hip and Groin Outcome Score (HAGOS) validated on patients with hip and groin pain

次要结局

  • Hip extensor and flexor rate of force development during isometric contraction(Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery)
  • Self-selected walking speed(Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery)
  • Time spend at sports activities during childhood(Preoperatively (Approx. in the time frame 0-10 weeks before surgery))
  • Employment(Preoperatively (Approx. in the time frame 0-10 weeks before surgery))
  • Visual analog scale, pain(Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery)
  • Patient-acceptable symptom state(Six month and one year after surgery)
  • EQ5D-Visual analog scale(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery)
  • Self-reported present sports activities(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery)
  • Education(Preoperatively (Approx. i the time frame 0-10 weeks before surgery))
  • Knee and trunk kinetics and kinematics during walking, stair climbing, stepping, sit-to-stand drop jump(Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery)
  • Presence of intra-articular pathology examined with FABER and impingement tests(Preoperatively (Approx. in the time frame 0-10 weeks before surgery) and one year after surgery)
  • Patient expectations(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 6 month and one year after surgery)
  • Failure(One year after surgery)
  • Re-operations and injections during the first year after surgery(3 month, 6 month, 9 month and one year after surgery)
  • Sports activities during childhood (age < 18)(Preoperatively (Approx. in the time frame 0-10 weeks before surgery))
  • Reasons for choosing surgery(Preoperatively (Approx. in the time frame 0-10 weeks before surgery))
  • Patient global treatment outcome(Six month and one year after surgery)
  • Time spend at preferred sports activity(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery)
  • Smoking habits(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery)
  • Alcohol intake(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), one year after surgery)
  • Intake of analgesia(Preoperatively (Approx. in the time frame 0-10 weeks before surgery), 3 month, 6 month, 9 month and one year after surgery)
  • Comorbidities(Preoperatively (Approx. in the time frame 0-10 weeks before surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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