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临床试验/NCT03966573
NCT03966573已完成不适用

Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints; 10 Patients With 27 to 34 Years Follow-up.

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)

研究概览

简要总结

This study evaluates function, quality of life and development of hip- and knee osteoarthritis minimum 15 years after unilateral femoral lengthening on people with idiopathic or post-traumatic anisomelia.

详细描述

This study has a cross-sectional design, where patients that completed femoral lengthening more than 15 years ago and fulfills the inclusion criteria's are invited to participate. Patients will undergo radiographic imaging to evaluate hip- and knee arthritis, axis deviaton and leg length discrepancy. To evaluate quality of life, function and pain, the participants will complete the forms EQ-5D-5L, Knee osteoarthritis outcome score (KOOS) and International physical activity questionnaire (IPAQ). Bilateral active hip and knee range of motion will be measured with hand held goniometer, and the functional tests 30 seconds sit to stand, hop tests and stair test will be conducted.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago

排除标准

  • •Patients that are lenghtened with innate pathology resulting in shortening of the limb, angle deviation and less musculature, for example congenital femoral deficiency or fibula hemimelia.
  • •Patients with acquired leg length discrepancy who have had infection in knee or hip joint

研究组 & 干预措施

Evaluating function, Radiographic imaging, Forms

Other
  • Tests for lower extremity function
  • Evaluating arthritis of hip and knee, leg length discrepancy and axis deviation radiographically
  • Evaluating quality of life, function and pain by forms

干预措施: Radiographic imaging (Radiation)

Evaluating function, Radiographic imaging, Forms

Other
  • Tests for lower extremity function
  • Evaluating arthritis of hip and knee, leg length discrepancy and axis deviation radiographically
  • Evaluating quality of life, function and pain by forms

干预措施: Evaluating function (Other)

Evaluating function, Radiographic imaging, Forms

Other
  • Tests for lower extremity function
  • Evaluating arthritis of hip and knee, leg length discrepancy and axis deviation radiographically
  • Evaluating quality of life, function and pain by forms

干预措施: Forms (Other)

结局指标

主要结局

measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)

时间窗: one day

The participant answer questions regarding pain, function, stiffness and quality of life regarding knee pain. Endpoints 0 - 4, where 0 indicate no problems and 4 indicate extreme problems

Lower extremity strength

时间窗: one day

30 seconds sit to stand test, measuring strength in lower extremities

Aerob capasity

时间窗: one day

Stair test, 18 steps up and down three times

hip or knee osteoarthritis

时间窗: One day

Radiographic imaging. Kellgren \& Lawrence classification and joint space width will be measured

Lower extremity function

时间窗: one day

Single leg hop tests

measure of health related quality of life with EQ-5D-5L

时间窗: one day

participants report the extent of problems they have with endpoints 1-5, where 1 is no problems and 5 is not able to in the five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The questionnaire also contains a vertical analogue scale with the labelled endpoints 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state, giving a valuation of the participants own health state that can be used as a quantitative measure of health outcome based on the patients' own judgement

measuring physical activity level with International Physical Activity Questionnaire (IPAQ)

时间窗: one day

Participants answer the amount of time being in vigorous activity, moderate activity, walking and sitting during the last 7 days. Answers are given in number of days in each of the activity categories, and time in hours and minutes on a regular day the actual week

Active range of motion

时间窗: one day

Hand held goniometric measurement of active range of motion in hip and knee bilaterally

次要结局

未报告次要终点

研究者

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

Patrick Aleksander Bjørge

Physiotherapist

Oslo University Hospital

研究点 (1)

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