Point Mini Device for Hand Amputation

Recruiting at 1 trial location

Overseen By Rebecca Connolly

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Point Designs

Disqualifiers: Unhealed wounds, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

5 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Point Mini for hand amputation?

Research on osseointegrated implants, which are similar to the Point Mini treatment, shows they can improve stability and increase prosthesis use time for thumb amputees. Additionally, studies on powered digits like the S-Finger demonstrate successful use in dexterity tests, suggesting potential benefits for partial hand amputations. ^{1 2 3 4 5}

How does the Point Mini treatment for hand amputation differ from other treatments?

The Point Mini treatment is unique because it uses a miniaturized control system that allows for multiple prosthetic hand movements with minimal training, unlike traditional prosthetics that often require extensive training. This system enables users to perform daily activities with fewer compensatory movements, making it more user-friendly and efficient. ^{3 4 6 7 8}

What is the purpose of this trial?

The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss 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.

Research Team

Levin Sliker, PhD

Principal Investigator

CEO, Point Designs

Eligibility Criteria

This trial is for a small group of 5 children who have lost part of their hand, either from birth or due to an accident. The study aims to see if they can perform certain tasks using the Point Mini system.

Inclusion Criteria

Fluent in English

My thumb is fully functional.

I am between 5 and 15 years old.

Exclusion Criteria

I do not have any serious health issues that are not under control.

My limb's condition may limit my full participation in the study.

I do not have major nerve or brain function issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are temporarily fit with the Point Mini finger prosthetic system and perform several tasks to validate user needs

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and the effectiveness of the prosthetic system after the initial session

2-4 weeks

Treatment Details

Interventions

• Point Mini

Trial Overview The Point Mini system is being tested in this trial. It's designed for children with partial-hand upper limb loss, and the goal is to see if it helps them complete specific tasks successfully.

Participant Groups

Group I: Prosthesis Experimental Treatment 1 Intervention

Patient is temporarily fit with Point Mini finger prosthetic system

Who Is Running the Clinical Trial?

Point Designs

Lead Sponsor

Trials

7

Recruited

70+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Partial hand amputations are common, with an incidence of about 1 in 18,000 people in western countries, yet treatment options have not significantly advanced due to challenges like anatomical variability and the complexity of restoring motor and sensory functions.

Current solutions for partial hand amputations often depend on skilled technicians for fitting rather than modern engineering techniques, highlighting a need for innovative approaches to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of the Partial Hand Amputation: An Engineering Perspective. Imbinto, I., Peccia, C., Controzzi, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A biomechanical study of osseointegrated patient-matched additively manufactured implant for treatment of thumb amputees. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Functional and cosmetic outcome of single-digit ray amputation in hand. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of the Partial Hand Amputation: An Engineering Perspective. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The S-Finger: A Synergetic Externally Powered Digit With Tactile Sensing and Feedback. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Osseointegrated Finger Prostheses Using a Tripod Titanium Mini-Plate. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Quantitative functional evaluation of a 3D-printed silicone-embedded prosthesis for partial hand amputation: A case report. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Touch Hand 4.5: low-cost additive manufacturing prosthetic hand participated in Cybathlon 2020 ARM discipline. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Clinical application study of multifunctional prosthetic hands. [2020]