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

Completed · Not applicable

Conditions studied: Amputation; Traumatic, Hand

In brief

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.

Key facts

Study ID

NCT05012683

Run by

Point Designs

People needed

11

Starts

2021-01-05

Expected to finish

2022-12-31

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Point Designs — Lafayette, Colorado, United States
• Arm Dynamics — Overland Park, Kansas, United States
• Arm Dynamics — Maple Grove, Minnesota, United States
• Arm Dynamics — Portland, Oregon, United States
• Arm Dynamics — Philadelphia, Pennsylvania, United States
• Arm Dynamics — Houston, Texas, United States
• Arm Dynamics — Irving, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.