ORTHOPUS develops assistive technologies to address the lack of availability of medical devices in low and middle income countries.
With the help of HI (Handicap International) Nepal, the need for upper limb prostheses was identified. Indeed, according to the literature - especially Efficiency of voluntary opening hand and hook prosthetic devices: 24 years of development? (JRRD, Volume 49, Number 4, 2012) -, today available solutions do not fully address patients’ needs.
In Nepal, only 2 upper limb prostheses options are generally proposed to patients because of supply and cost constraints.
ORTHOPUS’ objective is to extend patients’ autonomy with a new set of prosthetic solutions by offering low cost but high quality devices (according to CE marking requirements). Another of the ORTHOPUS' missions is also to address supply and cost constraints.
In addition with this grasping capabilities expansion (shown in figure “Comparative scheme - Standard VS ORTHOPUS prosthetic solutions” enclosed to the registration), we hypothesize that the set of upper limb prosthetics solutions will:
- improve the autonomy of users (professional reintegration with the ability to perform manual work)
- improve the well-being in everyday life (social reintegration)
ORTHOPUS’ prosthetic solution is composed of 3 solutions:
- an aesthetic articulated hand
- a mechanical wrist
- a work hook
In order to assess the different stated hypotheses, a clinical trial is set jointly with HI Nepal. 14 patients will be enrolled in 2 cohorts (n1 = 7, n2 = 7), the first one is constituted with patients usually using an aesthetic passive hand whereas the second one comprise patients normally equipped with voluntary opening hand.
After selecting and getting the informed consent of the patients, a month to make the sockets and adapt it to patients is planned. An evaluation of their quality of life will be done with the WHO QOL - BREF quality of life assessment.
ORTHOPUS’ set of prosthetic solutions will be tested by them over one month. They will have to fill on a daily basis a survey (OPUS) assessing their use of the prostheses. At the end of the test period, different questionnaires and surveys will be filled during a last interview to collect data.
Data will be analysed in order to extract evidence for or against the trial hypotheses. With these results a report will be written and submitted to the GATE (Global Cooperation on Assistive Health Technology) community managed by WHO. This report will also feed the ORTHOPUS R&D with patients’ feedbacks and, research findings will be shared publicly on different social media in respect with patient privacy.
Principal Investigator ( 1 )
- ORTHOPUS prosthetic accessory: 0109 - Wrist
The ORTHOPUS mechanical wrist device is intended to provide an external wrist joint only for external upper limb prostheses with pronation/supination passive motion (activation with external force), a quick connection (with automatic lock) and manual disconnection of the mechanical wrist connectors.
The mechanical wrist connector allows to quickly switch between different type of terminal devices (hand or tools)
- ORTHOPUS prosthetic terminal device: 0112 - Hook
The ORTHOPUS body-powered hook is a Voluntary Opening (VO) device made of aluminium intended to provide high grasping capabilities under harsh environments.
- ORTHOPUS prosthetic terminal device: 0105 - Aesthetic Articulated Hand
The ORTHOPUS aesthetic articulated hand is intended to provide a replacement limb in order to hide the loss of the original one. It is composed of an aesthetic glove (18 colors and 3 sizes, silicone made) and of an internal structure that can be bent to achieve a given position allowing the user to grasp small and light objects.
- ORTHOPUS prosthetic accessory: 0104 - body powered harness
The ORTHOPUS body powered harness is intended to allow the patient to actuate the 0109 - Wrist device. It will be installed on the patient’s contralateral shoulder and linked to the 0109 - Wrist device with a cable.
ORTHOPUS prosthetic terminal devices and accessories will be compared with previous prosthetic devices used by patients participating in the trial. Two cohorts will be constituted with patients previously equipped with aesthetic passive hands solutions or with voluntary opening hands
Unilateral transradial or wrist-disarticulation amputee
20 to 50 years of age
At least 1 year from date of amputation
Have been using upper limb prosthesis previously
Be able to independently provide informed and independant consent
Be willing to comply with study procedures
Independent function by self-report
Free of any health ailment that would impair physical function
Congenital anomaly of upper limb
Bilateral wrist disarticulation or transradial amputation
Any condition that would prevent participation and pose increased risk (e.g. shoulder impingement, sub-acromial bursitis, severe arthritis of the shoulder, elbow, wrist, or fingers)
Injuries of the upper limb within the past 90 days (surgeries, sprains, strains, or fractures).
Younger than 20 or older than 50 years of age
Unwillingness/inability to follow instructions
History of acute or chronic skin breakdown on the residual limb
Any health ailment that would impair physical function