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Prosthesis

e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees) for Prosthesis User

N/A
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months post-op
Awards & highlights

Study Summary

This study is evaluating whether a new prosthetic device can help people with amputations regain some of the functionality of their missing limbs.

Eligible Conditions
  • Prosthesis User
  • Neuroma
  • Amputation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Change in Electrical signal quality between implanted electrodes and test prosthesis
Secondary outcome measures
Change in Pain Level as measured by DVPRS (Defense and Veterans Pain Rating Scale)
Change in Pain Level as measured by LANSS surveys
Change in Pain Level as measured by PROMIS (Patient Reported Outcomes Measurement Information System) Questionnaire
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trasnhumeral e-OPRA ImplantExperimental Treatment1 Intervention
This arm includes patients with transhumeral amputation that will receive the e-OPRA implant system.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,498 Previous Clinical Trials
11,936,348 Total Patients Enrolled
University of MichiganLead Sponsor
1,793 Previous Clinical Trials
6,373,886 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations
Paul Cederna 2020. "An Osseoanchored Percutaneous Prosthesis Study Evaluating Stable Neural Signal Transmission in Subjects With Transhumeral Amputations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03957226.
~0 spots leftby Apr 2025
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