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Scientific Articles   |    
Single-Event Multilevel Surgery in Children with Spastic DiplegiaA Pilot Randomized Controlled Trial
Pamela Thomason, BPhty, MPT1; Richard Baker, PhD, CEng, CSci2; Karen Dodd, PhD3; Nicholas Taylor, PhD4; Paulo Selber, MD, FRACS5; Rory Wolfe, PhD6; H. Kerr Graham, MD, FRCS(Ed), FRACS7
1 Hugh Williamson Gait Laboratory, Royal Children's Hospital, Melbourne, 50 Flemington Road, Parkville, Victoria 3052, Australia. E-mail address: pam.thomason@rch.org.au
2 Murdoch Childrens Research Institute, 50 Flemington Road, Parkville, Victoria 3052, Australia
3 Faculty of Health Sciences, La Trobe University, Bundoora, Victoria 3086, Australia
4 La Trobe University, Eastern Health, Bundoora, Victoria 3086, Australia
5 Orthopaedic Department, Royal Children's Hospital, Melbourne, 50 Flemington Road, Parkville, Victoria 3052, Australia
6 Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria 3004, Australia
7 The University of Melbourne, Parkville, Victoria 3052, Australia
View Disclosures and Other Information
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from the Hugh Williamson Foundation and the Murdoch Childrens Research Institute and less than $10,000 from the National Health and Medical Research Council, The Centre for Clinical Research Excellence in Clinical Gait Analysis and Gait Rehabilitation. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

A commentary by Mark F. Abel, MD, and Diane L. Damiano, PhD, PT, is available at www.jbjs.org/commentary and is linked to the online version of this article.
Investigation performed at the Royal Children's Hospital, Melbourne, Australia

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Mar 02;93(5):451-460. doi: 10.2106/JBJS.J.00410
A commentary by Diane L. Damiano, PhD, PT, is available here
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Abstract

Background: 

Single-event multilevel surgery is considered the standard of care to improve gait and functioning of children with spastic diplegic cerebral palsy. However, the evidence base is limited. This pilot study is the first randomized controlled trial of single-event multilevel surgery, to our knowledge.

Methods: 

Nineteen children (twelve boys and seven girls with a mean age of nine years and eight months) with spastic diplegia were enrolled. Eleven children were randomized to the surgical group and eight, to the control group. The control group underwent a program of progressive resistance strength training. The randomized phase of the trial concluded at twelve months. The control group then exited the study and progressed to surgery, whereas the surgical group continued to be followed in a prospective cohort study. The primary outcome measures were the Gait Profile Score (GPS) and the Gillette Gait Index (GGI). Secondary outcome measures were gross motor function (Gross Motor Function Measure-66 [GMFM-66]), functional mobility (Functional Mobility Scale [FMS]), time spent in the upright position, and health-related quality of life (Child Health Questionnaire [CHQ]).

Results: 

A total of eighty-five surgical procedures were performed, with a mean of eight procedures per child (standard deviation, four). The surgical group had a 34% improvement in the GPS and a 57% improvement in the GGI at twelve months. The control group had a small nonsignificant deterioration in both indices. The between-group differences for the change in the GPS (-5.5; 95% confidence interval, -7.6 to -3.4) and the GGI (-218; 95% confidence interval, -299 to -136) were highly significant. The differences between the groups with regard to the secondary outcome measures were not significant at twelve months. At twenty-four months after surgery, there was a 4.9% increase in the GMFM-66 score and improvements in the FMS score, time spent in the upright position, and the physical functioning domain of the CHQ in the surgical group.

Conclusions: 

This study provides Level-II evidence that single-event multilevel surgery improves the gait of children with spastic diplegic cerebral palsy twelve months after surgery. Improvements in other domains, including gross motor function and quality of life, were not observed until twenty-four months after surgery.

Level of Evidence: 

Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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