A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions

Abstract

Background: Assistive products are items which allow older people and people with disabilities to be able to live a healthy, productive and dignified life. It has been estimated that approximately 1.5% of the world's population need a prosthesis or orthosis.

Objective: The objective of this study was to systematically identify and review the evidence from randomized controlled trials assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions.

Methods: Literature searches, completed in September 2015, were carried out in fourteen databases between years 1995 and 2015. The search results were independently screened by two reviewers. For the purpose of this manuscript, only randomized controlled trials which examined interventions using orthotic or prosthetic devices were selected for data extraction and synthesis.

Results: A total of 342 randomised controlled trials were identified (319 English language and 23 non-English language). Only 4 of these randomised controlled trials examined prosthetic interventions and the rest examined orthotic interventions. These orthotic interventions were categorised based on the medical conditions/injuries of the participants. From these studies, this review focused on the medical condition/injuries with the highest number of randomised controlled trials (osteoarthritis, fracture, stroke, carpal tunnel syndrome, plantar fasciitis, anterior cruciate ligament, diabetic foot, rheumatoid and juvenile idiopathic arthritis, ankle sprain, cerebral palsy, lateral epicondylitis and low back pain). The included articles were assessed for risk of bias using the Cochrane Risk of Bias tool. Details of the clinical population examined, the type of orthotic/prosthetic intervention, the comparator/s and the outcome measures were extracted. Effect sizes and odds ratios were calculated for all outcome measures, where possible.

Conclusions: At present, for prosthetic and orthotic interventions, the scientific literature does not provide sufficient high quality research to allow strong conclusions on their effectiveness and cost-effectiveness.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow diagram for selection of studies included in the systematic review.

Fig 2. Examples, from the studies included in the systematic review, of prosthetic interventions.

Prosthesis training with Vacuum Assisted Socket System (Harmony®). In the early stages of adapting, the pressure gauge is maintained to control the vacuum. At a later stage it will be removed and the prosthesis refined (a) [25] (image courtesy of Dr Stefano Brunelli); ICEX socket (image courtesy of Össur, UK) (b).

Fig 3. Examples, from the studies included in the systematic review, of upper limb orthotic interventions for individuals with osteoarthritis.

Neoprene (a) and thermoplast (b) thumb splints [32] (images courtesy of Dr Stéphanie J.E. Becker); Fabrifoam thumb support 202 orthosis (c and d) [62] (images courtesy of Handaid AB); thermoplastic splint (e) [35] (image courtesy of Professor Anamaria Jones).

Fig 4. Examples, from the studies included in the systematic review, of lower limb orthotic interventions for individuals with osteoarthritis.

Functional (a) and sham (b) foot orthoses [40] (images from: https://link.springer.com/article/10.1007/s10067-015-2946-6, by Halstead et al. licenced under CC BY 4.0); lateral wedge foot orthosis (c) [33] (image courtesy of Professor Kim Bennell); Moleca® shoes (d) [69] (image courtesy of Professor Francis Trombini-Souza); foot orthoses (e) and rocker-sole footwear (f) [43] (images from: https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/1471-2474-15-86, by Menz et al. licenced under CC BY 4.0).

Fig 5. Examples, from the studies included in the systematic review, of orthotic interventions for individuals with rheumatoid arthritis and juvenile idiopathic arthritis.

Control (a, b and c) and custom (d, e and f) foot orthoses [38] (images courtesy of Dr Andrea Coda; Control (g) and custom (h) foot orthoses [44] (images courtesy of Dr Primoz Novak).

Fig 6. Examples, from the studies included in the systematic review, of orthotic interventions for individuals post stroke.

WalkAide foot drop stimulator (a) and ankle foot orthosis (b) [115] (images courtesy of Dr Dirk Everaert); Bioness L300 foot drop stimulator [116] (image courtesy of Bioness Inc.).

Fig 7. Examples, from the studies included in the systematic review, of orthotic intervention for individuals with carpal tunnel syndrome.

Lumbrical splint [144] (image courtesy of Dr Nancy A. Baker).

Fig 8. Examples, from the studies included in the systematic review, of orthotic interventions for individuals with plantar fasciitis.

ErgoPad redux foot orthosis (a and b) [168] (images courtesy of Bauerfeind AG); custom (c and d) and prefabricated (e and f) foot orthoses [159] (images courtesy of Ms Valéria Baldassin).

Fig 9. Examples, from the studies included in the systematic review, of orthotic interventions for individuals with diabetes.

Custom-made shoe with custom-made insert (a) [199] (image courtesy of Dr Sicco Bus); customised and prefabricated foot orthoses (b) [200] (image courtesy of Dr Joanne Paton); control and custom foot orthoses and athletic footwear (c) [198] (image courtesy of Professor Joshua Burns).