NCT05012683

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Point Designs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Amputation; Traumatic, Hand

Interventions

Type	Name	Description
DEVICE	Point Partial	Patient is fit with Point Partial partial finger prosthetic system

Timeline

• Start date: 2021-01-05
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2021-08-19
• Last updated: 2025-01-28
• Results posted: 2024-01-23

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study