Validation of Point Partial User Needs With Partial Finger Amputees

Amputation; Traumatic, Hand Clinical Trial

Official title:

Validation of Point Partial User Needs With Partial Finger Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05012657
• Other study ID #: 299089
• Status: Completed
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Point Designs
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Hand

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Denver | Anschutz Medical Campus	Aurora	Colorado
United States	Point Designs	Lafayette	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Point Designs	University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAL-1	User wears Point Partial(s) for a full day (Pass/Fail)	Day 1 (8 hours)
Primary	VAL-2	User flexes and extends the Point Partial(s) without using contralateral hand (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-3.1	User lifts a 25 lb. bag with Point Partial(s) (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-3.2	User grips a hammer with Point Partial(s) and drives a nail into a piece of wood (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-4	User releases Point Partial(s) while performing an active grasp by pressing the dorsal button (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-5	User positions Point Partial(s) into each of the locking positions (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-6	User activates spring-back mechanism by using (1) contralateral hand, (2) tabletop, and (3) side or thigh throughout day without failed extension (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-7	User grips a 5 lb. cylindrical smooth object using Point Partial(s) for 10 seconds (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-8	User picks up 1 coin from a smooth tabletop (Pass/Fail)	Day 1 (10 minutes)
Primary	VAL-9	User performs VAL-1 through VAL-8 (Pass/Fail)	Day 1 (8 hours)