To Assess the Utility of the Point Digit in a Clinical Take-home Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2022-12-31

Brief Summary

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This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit 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

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Prosthesis

Baseline outcome measurements will be performed without a prosthesis

Group Type NO_INTERVENTION

No interventions assigned to this group

Prosthesis

Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting

Group Type EXPERIMENTAL

Point Digit

Intervention Type DEVICE

Patient is fit with Point Digit partial hand prosthetic system

Interventions

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Point Digit

Patient is fit with Point Digit partial hand prosthetic system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Partial hand amputees with 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

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 occupational therapist evaluation
* Serious uncontrolled medical problems as judged by the project therapist.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No