Surgical Treatment of Chronic Neuropathic Pain

Last updated: March 25, 2024
Sponsor: Axogen Corporation
Overall Status: Terminated

Phase

N/A

Condition

Pain (Pediatric)

Pain

Treatment

Surgical Management of Neuroma

Clinical Study ID

NCT04287075
PAI-CP-001
  • Ages > 18
  • All Genders

Study Summary

Observational registry study assessing the subject's pain history and the impact of surgery for the treatment of chronic neuropathic pain by comparing post-operative outcomes (pain level, pain medication usage, quality of life outcomes, and nerve functional outcome) to pre-operative levels.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be Age ≥ 18 years
  2. Have a documented diagnosis of chronic neuropathic pain
  3. In the opinion of the investigator, be considered at the time of screening a likelycandidate for surgical treatment of their neuropathic pain according to institutionalstandard of care.
  4. Be willing to participate in data collection and all follow-up assessments throughoutand for the entire duration of follow-up

Exclusion

Exclusion Criteria:

  1. Subjects who, in the opinion of the investigator, have not or likely will not completethe required follow-up assessments.
  2. Subjects who are currently enrolled in another clinical trial;
  3. Subjects who have undergone previous surgical treatment of pain from symptomaticneuroma in the target nerve(s);
  4. Subjects who are undergoing treatment(s)/intervention(s) for other condition(s) which,in the opinion of the investigator, may confound assessment of pain or interfere withthe study measurements.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Surgical Management of Neuroma
Phase:
Study Start date:
February 19, 2020
Estimated Completion Date:
January 24, 2024

Study Description

This observational registry will evaluate the subject's healthcare journey and pain history through detailed medical history and record review. For patients who undergo surgical treatment for pain, the registry will capture standardized outcomes measures to assess key factors such as post-operative pain, pain medication usage, quality of life outcomes, and functional outcome of associated nerves as compared to pre-operative levels.

Connect with a study center

  • Foundation for Orthopaedic Research and Education

    Tampa, Florida 33637
    United States

    Site Not Available

  • Optim Orthopeidcs

    Savannah, Georgia 31405
    United States

    Site Not Available

  • Indiana Hand to Shoulder Center

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Austin Foot and Ankle Specialists

    Austin, Texas 78746
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Washington Nerve Institute

    McLean, Virginia 22102
    United States

    Site Not Available

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