Laser scanning comparable to casting in pediatric ankle-foot orthosis construction

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
136 pediatric patients recommended for ankle-foot orthoses were randomized to receive a device either made with standard molding and casting or with laser scanning using computer-aided design and computer-aided manufacturing (LSCAD/CAM technology). The purpose of this study was to determine if either AFO production method was associated with significant differences in production time, orthosis length of life, patient satisfaction, and cost-effectiveness. Although results demonstrated Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Non-Industry funded
Sponsor: National Institute for Health Research
Conflicts: None disclosed
Why was this study needed now?
Modification of impaired functional and structural aspects of neuromuscular and musculoskeletal systems can be accomplished with ankle-foot orthosis devices. Orthoses are normally produced through taking a negative limb cast from the patient, filling the negative cast with plaster to develop a positive cast, and then molding over the positive cast with polypropylene sheets. However, newer casting methods involving laser scanning have been proposed to provide more accurate casts with the aid of computer-assisted imaging. Thus, the aim of this study was to determine if there were any significant differences between standard casts and casts produced by laser scanning with computer-aided design and computer-aided manufacturing (LSCAD/CAM technology).
What was the principal research question?
For pediatric patients referred for ankle-foot orthoses (AFOs), did casting produced through LSCAD/CAM technology or standard mold casting yield significant differences in time to the production of well-fitting casts, patient satisfaction and function, and cost-effectiveness when compared over a 12-month follow-up period?
Population: 136 patients under the age of 18 years recommended for rigid or hinged ankle-foot orthoses (AFOs) were included in this study. All patients underwent both casting methods within the same session (the order of which casting method would be performed first was randomized). Randomization was performed a second time to determine if patient AFO would be produced from standard mold casting or LSCAD/CAM casting. All casts were offset by 1% in all dimensions to allow for growth and ease of placement and removal (Males mean age= 10.7+/-4.9, n=75 | Females mean age=9.8+/-4.1, n=59).
Intervention: LSCAD/CAM group: patients were given polypropylene AFO imaged by laser via FastSCAN (Polhemus, Colchester, VT, USA) and produced by Relief Orthotics (Airdrie, Scotland) (n=65).
Comparison: Cast group: patients were given polypropylene AFO made by negative and positive plaster casts draped in standard format (n= 71).
Outcomes: The primary outcome measure was the length of time to produce high-quality casting, including times for molding and rectification processes. Secondary outcome measures included time to cast/scan patients' limbs, the length of time to fit the AFO, the number of days between initial scanning/casting to completion of AFO, and length of AFO life (in days). Patient satisfaction scores included a "Satisfaction with Device" (9 items) and a "Satisfaction with Service" (10 items) questionnaire, both of which were assessed with a 4-point Likert scale ranging from 'strongly agree' to 'strongly disagree'. A cost-effectiveness analysis was also performed, with time to functional AFO as the primary outcome (from a societal perspective).
Methods: RCT: double-blinded, cost-effective analysis
Time: Outcomes of interest were evaluated at 3, 6, 9, and 12 months post-AFO fitting.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.