Point Mini 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: 4

14 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

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

What safety data exists for the Point Mini treatment for hand amputation?

The research articles reviewed do not provide specific safety data for the Point Mini treatment for hand amputation. ^{1 2 3 4 5}

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

The treatment Point Mini is unique because it may involve the use of botulinum toxin type A, which has been shown to effectively reduce pain and improve prosthetic fit in amputees. This approach is different from traditional pain management methods, as it targets specific trigger points in the muscles to alleviate pain and enhance limb function. ^{6 7 8 9 10}

What is the purpose of this trial?

The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.

Research Team

Levin Sliker, PhD

Principal Investigator

Point Designs

Eligibility Criteria

This trial is for children with partial hand deficiencies due to congenital or traumatic amputation. Participants will be compared using their current prosthetic treatment, if any, against the Point Mini system.

Inclusion Criteria

Fluent in English

I have lost part of my hand, including at least the index or middle finger.

My thumb is fully functional.

Exclusion Criteria

My health issues are under control.

Significant cognitive deficits as determined upon clinical evaluation

Significant neurological deficits as determined upon clinical evaluation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline outcome measurements performed with subject's existing partial hand prosthetic treatment

4 weeks

1 visit (in-person)

Treatment with Point Mini

Participants use the Point Mini system and are evaluated on several metrics

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Point Mini

Trial Overview The study tests the effectiveness of the Point Mini system over a two-month period versus one month with their usual prosthesis or assistive device. It's a crossover design where kids use both treatments at different times and are assessed on function and usage.

Participant Groups

Group I: Point Mini Experimental Treatment 1 Intervention

Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.

Group II: Current/No Device Active Control 1 Intervention

Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device.

Who Is Running the Clinical Trial?

Point Designs

Lead Sponsor

Trials

7

Recruited

70+

Children's Healthcare of Atlanta

Collaborator

Trials

172

Recruited

108,000+

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

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

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

Revision of painful distal tip amputations. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Traumatic Finger Amputation in the U.S. Military. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

[Update on prosthesis for partial hand and finger amputations]. [2022]

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

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

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

Intradermal botulinum toxin type A injection effectively reduces residual limb hyperhidrosis in amputees: a case series. [2022]

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

Managing phantom pain. [2006]

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

Postamputation Residual Limb Pain Severity and Prevalence: A Systematic Review and Meta-Analysis. [2023]

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

Amputation surgery. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Long-term treatment of phantom- and stump pain with Botulinum toxin type A over 12 months. A first clinical observation]. [2022]