Validation of Point Partial User Needs With Partial Finger Amputees

The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

Study Overview

• Status: Completed
• Conditions: Amputation; Traumatic, Hand
• Intervention / Treatment: Device: Point Partial

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Levin Sliker, PhD; Phone Number: 7206004753; Email: levin@pointdesignsllc.com
• Study Contact Backup: Name: Richard Weir, PhD; Phone Number: 8479121032; Email: richard.weir@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver | Anschutz Medical Campus
    • Lafayette, Colorado, United States, 80026
      • Point Designs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Partial finger amputees with partial absence of index and/or middle fingers and presence of thumb. Additional finger loss is acceptable if all other criterion are met.
• Fluent in English
• Individuals aged 18 or greater
• Patients may present with either fused or mobile MCP joints.

Exclusion Criteria:

• Significant cognitive deficits as determined upon clinical evaluation
• Significant neurological deficits as determined upon clinical evaluation
• Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
• Uncontrolled pain or phantom pain impacting full participation in the study as determined upon OT evaluation
• Serious uncontrolled medical problems as judged by the project therapist.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prosthesis; Patient is temporarily fit with Point Partial partial finger prosthetic system	Device: Point Partial; The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAL-1	User wears Point Partial(s) for a full day (Pass/Fail)	Day 1 (8 hours)
VAL-2	User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail)	Day 1 (10 minutes)
VAL-3.1	User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail)	Day 1 (10 minutes)
VAL-3.2	User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail)	Day 1 (10 minutes)
VAL-4	User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)	Day 1 (10 minutes)
VAL-5	User positions Point Partial(s) into each of the locking positions (Pass/Fail)	Day 1 (10 minutes)
VAL-6	User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail)	Day 1 (10 minutes)
VAL-7	User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail)	Day 1 (10 minutes)
VAL-8	User picks up 1 coin from a smooth tabletop (Pass/Fail)	Day 1 (10 minutes)
VAL-9	User performs VAL-1 through VAL-8 (Pass/Fail)	Day 1 (8 hours)

Collaborators and Investigators

• Sponsor: Point Designs
• Collaborators: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Traumatic
• Other Study ID Numbers: 299089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No