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Validation of Point Partial User Needs With Partial Finger Amputees

P

Point Designs

Status

Completed

Conditions

Amputation; Traumatic, Hand

Treatments

Device: Point Partial

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

5 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

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Prosthesis
Experimental group
Description:
Patient is temporarily fit with Point Partial partial finger prosthetic system
Treatment:
Device: Point Partial

Trial documents
2

Trial contacts and locations

2

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Central trial contact

Levin Sliker, PhD; Richard Weir, PhD

Data sourced from clinicaltrials.gov

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