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

Primary Purpose

Leg Length Inequality, Leg; Lengthening, Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Radiographic imaging
Evaluating function
Forms
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Leg Length Inequality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Evaluating function, Radiographic imaging, Forms

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 19, 2019
Last Updated
February 23, 2021
Sponsor
Oslo University Hospital
Collaborators
Sophies Minde AS
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1. Study Identification

Unique Protocol Identification Number
NCT03966573
Brief Title
Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
October 11, 2019 (Actual)
Study Completion Date
October 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sophies Minde AS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Length Inequality, Leg; Lengthening, Osteoarthritis, Knee, Osteoarthritis of Hip, Quality of Life

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluating function, Radiographic imaging, Forms
Arm Type
Other
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiographic imaging
Other Intervention Name(s)
Knee front, knee side, lower extremity axis front, lower extremity axis side, pelvis front
Intervention Description
Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.
Intervention Type
Other
Intervention Name(s)
Evaluating function
Other Intervention Name(s)
30 seconds sit to stand, single leg hop test, stair test, goniometric ROM measurement hip and knee
Intervention Description
Test function and physical capasity
Intervention Type
Other
Intervention Name(s)
Forms
Other Intervention Name(s)
EQ-5D-5L, KOOS - knee osteoarthritis outcome score, IPAQ - international physical activity questionnaire
Intervention Description
Forms for evaluating quality of life, pain, function
Primary Outcome Measure Information:
Title
hip or knee osteoarthritis
Description
Radiographic imaging. Kellgren & Lawrence classification and joint space width will be measured
Time Frame
One day
Title
Lower extremity strength
Description
30 seconds sit to stand test, measuring strength in lower extremities
Time Frame
one day
Title
Lower extremity function
Description
Single leg hop tests
Time Frame
one day
Title
Aerob capasity
Description
Stair test, 18 steps up and down three times
Time Frame
one day
Title
measure of health related quality of life with EQ-5D-5L
Description
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
Time Frame
one day
Title
measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)
Description
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
Time Frame
one day
Title
measuring physical activity level with International Physical Activity Questionnaire (IPAQ)
Description
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
Time Frame
one day
Title
Active range of motion
Description
Hand held goniometric measurement of active range of motion in hip and knee bilaterally
Time Frame
one day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0372
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
33410356
Citation
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.
Results Reference
derived

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

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