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

NCT ID: NCT03966573

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2019-10-11

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Radiographic imaging

Intervention Type RADIATION

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

Evaluating function

Intervention Type OTHER

Test function and physical capasity

Forms

Intervention Type OTHER

Forms for evaluating quality of life, pain, function

Interventions

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Radiographic imaging

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

Intervention Type RADIATION

Evaluating function

Test function and physical capasity

Intervention Type OTHER

Forms

Forms for evaluating quality of life, pain, function

Intervention Type OTHER

Other Intervention Names

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Knee front knee side lower extremity axis front lower extremity axis side pelvis front 30 seconds sit to stand single leg hop test stair test goniometric ROM measurement hip and knee EQ-5D-5L KOOS - knee osteoarthritis outcome score IPAQ - international physical activity questionnaire

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sophies Minde Ortopedi

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patrick Aleksander Bjørge

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 33410356 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018/416

Identifier Type: -

Identifier Source: org_study_id

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