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

Not Applicable

Completed

• Conditions: Leg; Lengthening; Leg Length Inequality; Osteoarthritis of Hip; Quality of Life; Osteoarthritis, Knee
• Interventions: Radiation: Radiographic imaging; Other: Evaluating function; Other: Forms

• Registration Number: NCT03966573
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2019-03-06
• Study First Submitted: 2019-03-19
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evaluating function, Radiographic imaging, Forms	Radiographic imaging	* 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
Evaluating function, Radiographic imaging, Forms	Evaluating function	* 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
Evaluating function, Radiographic imaging, Forms	Forms	* 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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway