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

Quality of Life Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966573
• Other study ID #: 2018/416
• Status: Completed
• Phase: N/A
• Start date: March 6, 2019
• Est. completion date: October 11, 2019

Study information

• Verified date: February 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Radiographic imaging
Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.

Other:
• Evaluating function
Test function and physical capasity
• Forms
Forms for evaluating quality of life, pain, function

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sophies Minde AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hip or knee osteoarthritis	Radiographic imaging. Kellgren & Lawrence classification and joint space width will be measured	One day
Primary	Lower extremity strength	30 seconds sit to stand test, measuring strength in lower extremities	one day
Primary	Lower extremity function	Single leg hop tests	one day
Primary	Aerob capasity	Stair test, 18 steps up and down three times	one day
Primary	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
Primary	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
Primary	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
Primary	Active range of motion	Hand held goniometric measurement of active range of motion in hip and knee bilaterally	one day