Thomason, J Bone Joint Surg Am 2011 - Single-Event Multilevel Surgery in Children with Spastic Diplegia: A Pilot Randomized Controlled Trial

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Single-Event Multilevel Surgery in Children with Spastic Diplegia: A Pilot Randomized Controlled Trial

Thomason, Graham, et al.·J Bone Joint Surg Am·2011·187 citations·RCT

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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

19 children (12 boys and 7 girls with a mean age of 9 years and 8 months) with spastic diplegia were enrolled.
11 children were randomized to the surgical group and 8, to the control group.
The control group underwent a program of progressive resistance strength training.
The randomized phase of the trial concluded at 12 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 85 surgical procedures were performed, with a mean of 8 procedures per child (standard deviation, 4).
The surgical group had a 34% improvement in the GPS and a 57% improvement in the GGI at 12 months.
The control group had a small nonsignificant deterioration in both indices.
The between-group differences for the change in the GPS (25.5; 95% confidence interval, 27.6 to 23.4) and the GGI (2218; 95% confidence interval, 2299 to 2136) were highly significant.
The differences between the groups with regard to the secondary outcome measures were not significant at 12 months.
At 24 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 12 months after surgery. Improvements in other domains, including gross motor function and quality of life, were not observed until 24 months after surgery.

Copyright remains with the authors and publisher.

Single-Event Multilevel Surgery in Children with Spastic Diplegia: A Pilot Randomized Controlled Trial.

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Single-Event Multilevel Surgery in Children with Spastic Diplegia: A Pilot Randomized Controlled Trial

Thomason, Graham, et al.·J Bone Joint Surg Am·2011·187 citations·RCT

|

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

19 children (12 boys and 7 girls with a mean age of 9 years and 8 months) with spastic diplegia were enrolled.
11 children were randomized to the surgical group and 8, to the control group.
The control group underwent a program of progressive resistance strength training.
The randomized phase of the trial concluded at 12 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 85 surgical procedures were performed, with a mean of 8 procedures per child (standard deviation, 4).
The surgical group had a 34% improvement in the GPS and a 57% improvement in the GGI at 12 months.
The control group had a small nonsignificant deterioration in both indices.
The between-group differences for the change in the GPS (25.5; 95% confidence interval, 27.6 to 23.4) and the GGI (2218; 95% confidence interval, 2299 to 2136) were highly significant.
The differences between the groups with regard to the secondary outcome measures were not significant at 12 months.
At 24 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 12 months after surgery. Improvements in other domains, including gross motor function and quality of life, were not observed until 24 months after surgery.

Copyright remains with the authors and publisher.

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