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Validation of Point Partial User Needs With Partial Finger Amputees

Primary Purpose

Amputation; Traumatic, Hand

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Point Partial
Sponsored by
Point Designs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Amputation; Traumatic, Hand

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Colorado Denver | Anschutz Medical CampusRecruiting
  • Point DesignsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prosthesis

Arm Description

Patient is temporarily fit with Point Partial partial finger prosthetic system

Outcomes

Primary Outcome Measures

VAL-1
User wears Point Partial(s) for a full day (Pass/Fail)
VAL-2
User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail)
VAL-3.1
User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail)
VAL-3.2
User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail)
VAL-4
User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)
VAL-5
User positions Point Partial(s) into each of the locking positions (Pass/Fail)
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)
VAL-7
User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail)
VAL-8
User picks up 1 coin from a smooth tabletop (Pass/Fail)
VAL-9
User performs VAL-1 through VAL-8 (Pass/Fail)

Secondary Outcome Measures

Full Information

First Posted
August 12, 2021
Last Updated
September 26, 2022
Sponsor
Point Designs
Collaborators
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05012657
Brief Title
Validation of Point Partial User Needs With Partial Finger Amputees
Official Title
Validation of Point Partial User Needs With Partial Finger Amputees
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Point Designs
Collaborators
University of Colorado, Denver

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amputation; Traumatic, Hand

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prosthesis
Arm Type
Experimental
Arm Description
Patient is temporarily fit with Point Partial partial finger prosthetic system
Intervention Type
Device
Intervention Name(s)
Point Partial
Intervention Description
The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
Primary Outcome Measure Information:
Title
VAL-1
Description
User wears Point Partial(s) for a full day (Pass/Fail)
Time Frame
Day 1 (8 hours)
Title
VAL-2
Description
User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-3.1
Description
User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-3.2
Description
User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-4
Description
User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-5
Description
User positions Point Partial(s) into each of the locking positions (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-6
Description
User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-7
Description
User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-8
Description
User picks up 1 coin from a smooth tabletop (Pass/Fail)
Time Frame
Day 1 (10 minutes)
Title
VAL-9
Description
User performs VAL-1 through VAL-8 (Pass/Fail)
Time Frame
Day 1 (8 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Levin Sliker, PhD
Phone
7206004753
Email
levin@pointdesignsllc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Weir, PhD
Phone
8479121032
Email
richard.weir@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado Denver | Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Weir, PhD
Phone
847-912-1032
Email
richard.weir@cuanschutz.edu
Facility Name
Point Designs
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Levin Sliker, PhD
Phone
720-600-4753
Email
levin@pointdesignsllc.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Validation of Point Partial User Needs With Partial Finger Amputees

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