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

Point Designs

Status: Completed

Conditions: Amputation; Traumatic, Hand

Treatments: Device: Point Partial

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05012683

299090

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 1 patient group

No Prosthesis, then Prosthesis

Experimental group

Description:

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.

Treatment:

Device: Point Partial