To Assess the Utility of the Point Partial in a Clinical Take-home Study of Partial Hand Amputees

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2022-12-31

Brief Summary

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This study will allow us to assess whether the Point Partial confers functional and psychological benefit to persons with partial finger amputations in an unconstrained environment. The use of the Point Partial outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.

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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

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Prosthesis, then Prosthesis

Baseline outcome measurements will be performed without a prosthesis. Then subject will be fit with a prosthesis and outcome measurements will be performed at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.

Group Type EXPERIMENTAL

Point Partial

Intervention Type DEVICE

Patient is fit with Point Partial partial finger prosthetic system

Interventions

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Point Partial

Patient is fit with Point Partial partial finger prosthetic system

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