Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Leg; Lengthening, Leg Length Inequality, Osteoarthritis, Knee, Osteoarthritis of Hip, Quality of Life

Intervention / Treatment
-----------------
* Radiation: Radiographic imaging
* Other: Evaluating function
* Other: Forms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Evaluating function, Radiographic imaging, Forms<br>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 | Radiation: Radiographic imaging<br>* Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.<br>* Other names: pelvis front;Other: Evaluating function<br>* Test function and physical capasity<br>* Other names: goniometric ROM measurement hip and knee;Other: Forms<br>* Forms for evaluating quality of life, pain, function<br>* Other names: IPAQ - international physical activity questionnaire;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip or knee osteoarthritis | Radiographic imaging. Kellgren & Lawrence classification and joint space width will be measured | One day | 
| Lower extremity strength | 30 seconds sit to stand test, measuring strength in lower extremities | one day | 
| Lower extremity function | Single leg hop tests | one day | 
| Aerob capasity | Stair test, 18 steps up and down three times | one day | 
| measure of health related quality of life with EQ-5D-5L | 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 | one day | 
| measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS) | 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 | one day | 
| measuring physical activity level with International Physical Activity Questionnaire (IPAQ) | 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 | one day | 
| Active range of motion | Hand held goniometric measurement of active range of motion in hip and knee bilaterally | one day |