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Regenerative Medicine

Traction Neurectomy for Morton's Neuroma

N/A
Recruiting
Led By Aviram M Giladi, MS, MD
Research Sponsored by Medstar Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of unilateral digit, multiple digit, or partial hand amputation
Discrete neuroma pain on clinical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessing change from baseline to 1 week, 1 month, 3 months and 6 months
Awards & highlights

Study Summary

This trial is testing a new surgery for people with hand or digit amputations to see if it's better than the current standard of care.

Eligible Conditions
  • Morton's Neuroma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have lost one or more fingers or part of your hand in the past.
Select...
You experience pain during a physical exam that is related to a neuroma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessing change from baseline to 1 week, 1 month, 3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessing change from baseline to 1 week, 1 month, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Generalized Anxiety Disorder measure (GAD-7)
PC-PTSD-5
PROMIS Global Health (GH) v1.2
+3 more
Secondary outcome measures
Brief Michigan Hand Outcomes Questionnaire (bMHQ)
Fine Motor Function - 9-Hole Peg Test (9HPT)
Functional Task Testing - Carrying Boxes
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Traction NeurectomyExperimental Treatment1 Intervention
simple excision and traction neurectomy
Group II: Regenerative Peripheral Nerve InterfaceExperimental Treatment1 Intervention
symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Traction Neurectomy
2014
N/A
~30

Find a Location

Who is running the clinical trial?

Medstar Health Research InstituteLead Sponsor
188 Previous Clinical Trials
115,541 Total Patients Enrolled
United States Department of DefenseFED
856 Previous Clinical Trials
225,515 Total Patients Enrolled
University of MichiganOTHER
1,782 Previous Clinical Trials
6,364,577 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities remaining to take part in this research?

"Affirmative. Data on clinicaltrials.gov points to this medical trial being open for recruitment, with a posted date of October 5th 2021 and the most recent update made on November 22nd 2022. The study is seeking 80 participants between two sites."

Answered by AI

To what purpose is this clinical trial being conducted?

"This clinical trial's primary endpoint is to measure the Short-Form McGill Pain Questionnaire (SF-MPQ-2) from Baseline to 1 week, 1 month, 3 months and 6 months. Secondary objectives include testing Fine Motor Function via a 9 Hole Peg Test, Grip Strength using a standard dynamometer, and Range of Motion by assessing active/passive movement in afflicted extremities plus internal control on unaffected digits & wrists."

Answered by AI

How many participants is the research team accepting for this trial?

"Affirmative, according to clinicaltrials.gov this trial is seeking participants. First posted on October 5th 2021 and recently modified on November 22nd 2022, the study requires 80 patients across 2 centers for completion."

Answered by AI
Recent research and studies
~7 spots leftby Jul 2024