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

Point Designs

Status: Completed

Conditions: Amputation; Traumatic, Hand

Treatments: Device: Point Digit

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04755790

253924

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

No Prosthesis

No Intervention group

Description:

Baseline outcome measurements will be performed without a prosthesis

Prosthesis

Experimental group

Description:

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

Treatment:

Device: Point Digit