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

Sponsor
Oslo University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03966573
Collaborator
Sophies Minde AS (Other)
10
1
1
7.2
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Radiographic imaging
  • Other: Evaluating function
  • Other: Forms
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
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.
Actual Study Start Date :
Mar 6, 2019
Actual Primary Completion Date :
Oct 11, 2019
Actual Study Completion Date :
Oct 11, 2019

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. hip or knee osteoarthritis [One day]

      Radiographic imaging. Kellgren & Lawrence classification and joint space width will be measured

    2. Lower extremity strength [one day]

      30 seconds sit to stand test, measuring strength in lower extremities

    3. Lower extremity function [one day]

      Single leg hop tests

    4. Aerob capasity [one day]

      Stair test, 18 steps up and down three times

    5. 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

    6. 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

    7. 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

    8. Active range of motion [one day]

      Hand held goniometric measurement of active range of motion in hip and knee bilaterally

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oslo University Hospital Oslo Norway 0372

    Sponsors and Collaborators

    • Oslo University Hospital
    • Sophies Minde AS

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Patrick Aleksander Bjørge, Physiotherapist, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT03966573
    Other Study ID Numbers:
    • 2018/416
    First Posted:
    May 29, 2019
    Last Update Posted:
    Feb 26, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 26, 2021