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

NCT03966573 | Completed

• 1 other identifier: 2018/416
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Evaluating function, Radiographic imaging, Forms

OTHER

* 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; Other: Evaluating function; Other: Forms

Interventions

Radiographic imaging RADIATION

Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.

Also known as: Knee front, knee side, lower extremity axis front, lower extremity axis side, pelvis front

Evaluating function, Radiographic imaging, Forms

Evaluating function OTHER

Test function and physical capasity

Also known as: 30 seconds sit to stand, single leg hop test, stair test, goniometric ROM measurement hip and knee

Evaluating function, Radiographic imaging, Forms

Forms OTHER

Forms for evaluating quality of life, pain, function

Also known as: EQ-5D-5L, KOOS - knee osteoarthritis outcome score, IPAQ - international physical activity questionnaire

Evaluating function, Radiographic imaging, Forms

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sophies Minde Ortopedi: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0372, Norway

Location

Related Publications (1)

• 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.

  PMID: 33410356 DERIVED

MeSH Terms

Conditions

Leg Length Inequality; Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Phantoms, Imaging

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: May 29, 2019
• Study Start: March 6, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become avaliable within 6 months of study completion
• Access Criteria: Shared in an open access publication

Locations

NO (1)