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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Osteoarthritis, Knee; Leg Length Inequality; Osteoarthritis of Hip; Leg; Lengthening
• Intervention / Treatment: Radiation: Radiographic imaging; Other: Evaluating function; Other: Forms

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0372
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Evaluating function, Radiographic imaging, 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

Radiation: Radiographic imaging; Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.; Other Names: Knee front; knee side; lower extremity axis front; lower extremity axis side; pelvis front; Other: Evaluating function; Test function and physical capasity; Other Names: 30 seconds sit to stand; single leg hop test; stair test; goniometric ROM measurement hip and knee; Other: Forms; Forms for evaluating quality of life, pain, function; Other Names: EQ-5D-5L; KOOS - knee osteoarthritis outcome score; 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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sophies Minde AS

Publications and helpful links

General Publications

• Bjorge PA, Tveter AT, Steen H, Gunderson R, Horn J. Femoral lengthening might impair physical function and lead to structural changes in adjacent joints: 10 patients with 27 to 34 years' follow-up. Acta Orthop. 2021 Jun;92(3):329-334. doi: 10.1080/17453674.2020.1866864. Epub 2021 Jan 7.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): October 11, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pathological Conditions, Anatomical; Bone Diseases; Bone Diseases, Developmental; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Leg Length Inequality
• Other Study ID Numbers: 2018/416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IDP that underlie results in a publication
• IPD Sharing Time Frame: Data will become avaliable within 6 months of study completion
• IPD Sharing Access Criteria: Shared in an open access publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No