Abstract
Introduction
WHO estimates that fewer than 15% of 100 million people worldwide in need of prosthetic and orthotic care (P&O) have access. Conflicts throughout the Middle East have led to an increase in people living with disabilities. People with a unilateral upper limb deficiency commonly seek cosmetic prostheses to help with social stigma, and to provide a support limb for bimanual tasks. The lack of prosthetic clinicians, and prohibitive cost of prostheses in many countries, have led to limited options for patients. In the Middle East, a cosmetic upper limb prosthesis costs $1000-$3000. In 2017, we initiated a 3D project at the MSF Amman Reconstructive Surgery Hospital, aiming to evaluate the feasibility of locally designing, manufacturing and fitting customized 3D printed below-elbow prostheses. The multi-disciplinary team included diverse specialties, including P&O, physiotherapy, occupational therapy and biomedical engineering.
Methods
Each patient first underwent clinical assessments to identify their specific needs. 3D surface scans of the stump and contralateral limb were acquired and used to design each socket and prosthesis. Components were 3D printed at the Irbid Fab Lab from various materials (rigid polylactic acid, semi-flexible co-polyester, flexible thermoplastic polyurethane). After fitting, clinical assessments were performed at various time points to improve the designs and refine the processes. Nine questions from the Orthotic & Prosthetic User Survey were used to determine patient satisfaction.
Ethics
This research fulfilled the exemption criteria set by the MSF Ethics Review Board (ERB) and thus did not require MSF ERB review. It was conducted with permission from Clair Mills, Operational Centre Paris, MSF.
Results
By Feb 2018, 14 patients were enrolled (29% female, 57% <15 yr, 50% trauma-related, 14% lost following enrollment) and 8 were fitted with 9 total prostheses (88% unilateral). Prostheses were worn a mean of 4h 43min per day (SD±3h 6min), with 90% patient satisfaction after 15 days (N=6 patients). Patients reported being satisfied with the weight and comfort of the prosthesis (Mean Satisfaction Score>3.8/4.0). Challenges include long-term durability of components and paint coating. The cost of raw materials to manufacture the 3D printed prostheses ranged from $20-$50.
Conclusion
We have shown the feasibility of locally designing, manufacturing and fitting 3D printed prostheses in this context; the project is ongoing. We are continuing to improve the durability of the prosthesis and to explore the possibility of remote design. Future directions include expansion of the project to other MSF contexts and further collaboration with external rehabilitation centers and technology partners, with the goal of increasing access to P&O care and further developing other potential 3D applications (eg, surgery, burns).
Conflicts of interest
None declared.
words
Pierre Moreau, Safa Herfat
Safa joined MSF in 2016 as the Technical Coordinator for the 3D Project, which aims to evaluate 3D technologies for medical humanitarian applications. Safa completed his PhD in Biomedical Engineering with a focus in Biomechanics & Tissue Engineering in 2011 and later joined the Orthopaedic Surgery Department at the University of California, San Francisco in 2012. His lab specializes in the biomechanical evaluation of orthopaedic surgical strategies using experimental biomechanical testing and finite element analysis. His research interests also include 3D technology, sensors and prosthetics.
Pierre is a physiotherapist. He completed a Master’s degree in rehabilitation science, focused on musculo-skeletal injuries. He has experience in burns, along with amputee treatment, and has worked in several hospitals and rehabilitation centres in France before joining MSF in 2015. Since then, he has worked as a physiotherapist in the field, participating in the preparation of burn rehabilitation protocols, and joined the 3D project at the end of 2016.
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420 words
Authors approved 19/April
Proofed on paper 26/april, sv check ethics, changes incorporated