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The purpose of this pilot trial is to determine whether the addition of gait laboratory analysis for surgical decision making, compared with the use of observational analysis alone, results in improved functional outcomes in ambulatory children with cerebral palsy undergoing multi-level lower extremity orthopaedic surgery.
Children with cerebral palsy, who are ambulatory, have an inefficient gait often associated with functional disability. Many of these children are candidates for orthopaedic surgery, which includes multi-level soft tissue and bony procedures. Pre-operative planning is based on the physical examination and visual (observational) analysis of the child's gait. In some centres, patients undergo additional gait analysis in a motion laboratory. While gait laboratory analysis is accepted as an important research tool, there is controversy about its clinical utility in decision making for the surgical management of this population. To date, no clinical trials have been undertaken to answer this question, and the appropriate clinical utilization of this technology is yet to be established. The consequence of this uncertainty is that ambulatory children with cerebral palsy are either being deprived of a useful assessment tool in some centres, or alternatively they are being subjected to an unnecessary evaluation that is both expensive and time consuming in other centres. A multi-centre randomized trial will provide evidence to support or refute the need for gait laboratory analysis for surgical decision-making for this population. This pilot randomized controlled trial in four sites will assess the feasibility of, and provide the template for the design and conduct of the definitive larger multi-centred trial to extend its generalizability across North America and other jurisdictions. The specific objectives include:
1. Establish the feasibility of implementing the randomized trial study design in multiple centres
2. Estimate recruitment rates and timelines
3. Establish responsiveness of outcome measures to finalize the primary & secondary outcomes
4. Estimate effect sizes of functional outcomes for sample size calculations
5. Establish data management system (web-based database) for definitive multi-centre study.
6. Assess feasibility, reliability and face validity of pilot health economic data forms to include health economic evaluation in the future definitive multi-centre trial.
Secondary objectives include:
7. Does the addition of gait analysis alter surgical decisions made from video observation alone, when performed in the setting of this pilot trial?
8. Evaluate the consistency of the surgical decision making: intra- & inter rater reliability
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Routine Observational Analysis (prior to procedure), Routine Observational analysis supplemented with Gait Lab Information (prior to procedure)
University of Wisconsin-Madison
The Hospital for Sick Children
Published on BioPortfolio: 2014-08-27T03:40:47-0400
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