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Clinical Outcome Assessments in Composite Endpoint for Upper Extremity Prosthetics

Clinical Context

An upper extremity amputation can substantially impact an individual’s quality of life and ability to function. Prosthetic devices are prescribed to individuals with arm amputations to assist with activities of daily living. Most available devices have a limited ability to assist patients with multiple arm motions simultaneously.

Device Description

The DEKA Arm System (De Novo DEN120016) is a prosthetic arm that can feature up to 10 degrees of freedom to assist with shoulder, elbow, wrist, and finger motion. The De Novo submission for this prosthetic system was granted in May 2014. The DEKA Arm System is a Class II upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components; see reclassification order DEN120016 (PDF).

Indications for Use

The DEKA Arm System consists of a prosthetic arm and accessories, which are used by a certified prosthetist to create a full upper extremity prosthesis indicated for individuals, age 18 years and older, who have partial or full upper limb amputations or congenital defects. The device is used to assist in activities of daily living (ADLs); see the De Novo Classification Request DEN120016 (PDF).

Context of Clinical Outcome Assessment (COA) Use

When evaluating the safety and effectiveness of this novel technology, a combination of 5 performance outcomes (PerfOs) and 6 patient-reported outcome (PRO) instruments were employed and measured at five timepoints throughout the clinical investigation. The PerfOs focused on assessing:

  • Device dexterity (Modified Box and Blocks Test of Manual Dexterity, Jebsen-Taylor Hand Function Test)
  • Performance of functional activities (Activities Measure for Upper Limb Amputees, Activities Performance Measure, Extended Activities Measure).

Impact on daily function was assessed with the following PRO instruments:

  • Upper Extremity Functional Scale
  • Upper Extremity Functional Use Scale 
  • Patient Specific Functional Scale
  • Trinity Amputations and Prosthetics Experience Scale
  • DEKA Arm Satisfaction Scale
  • DEKA Arm Usability Scale.

Lessons Learned

The DEKA Arm System De Novo submission is an example of successfully combining PerfOs and PRO instruments to evaluate patient experience and device effectiveness in an emerging technology. Substantial patient interaction with the device made it essential to use measures that originated from the patient interacting with the device to demonstrate safety and effectiveness.

 
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