Validation of Point Partial User Needs With Partial Finger Amputees

NCT ID: NCT05012657

Last Updated: 2024-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-03

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation; Traumatic, Hand

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Prosthesis

Patient is temporarily fit with Point Partial partial finger prosthetic system

Group Type EXPERIMENTAL

Point Partial

Intervention Type DEVICE

The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets

Interventions

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Point Partial

The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

Point Designs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Point Designs

Lafayette, Colorado, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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299089

Identifier Type: -

Identifier Source: org_study_id

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