Patient Reported Outcomes Following Targeted Muscle Reinnervation

NCT04658368 | Terminated

• 4 other identifiers: 2020-1466A539730SMPH/SURGERY/DENTL-PLASTC SRGYProtocol Version 11/2020
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the functional status and quality of life of patients undergoing Targeted Muscle Reinnervation (TMR) at time of major limb amputation (primary) or subsequent to major limb amputation (secondary). Participants can expect to be on study for about a year and will complete a short electronic survey and option phone interview.

Conditions

Amputation

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (3)

• Post-Amputation Quality of Life Survey

  The functional status and quality of life of patients who have undergone primary or secondary TMR will be measured using patient reported outcome instruments. 25-items scored on a 5 point likert scale will be combined for a score between 25 and 125, where higher scores indicate better quality of life. Items represent combined tools of the following PROMIS instruments: Ability to participate in social roles and activities, Global health, Pain intensity, self-efficacy for management chronic conditions social interactions, general self-efficacy, emotional support, social isolation. Higher scores mean better functioning.

  up to 18 months

• Change in Quality of Life Survey

  Compare pre-operative and post-operative functional status and quality of life of secondary TMR patients. 25-items scored on a 5 point likert scale will be combined for a score between 25 and 125, where higher scores indicate better quality of life. See attachments for more details.

  Baseline, post-surgery (up to 18 months)

• Qualitative Participant TMR Experience

  Patient desire, expectations and satisfaction with undergoing TMR will be measured qualitatively using survey and semi-structured interview responses. This measure will be analyzed with coding for recurring themes and reported narratively. A coding theme will be decided after preliminary review of interview transcripts.

  up to 18 months

Study Arms (4)

Control

Participants with a history of major limb amputation at the University of Wisconsin (UW) that did not undergo TMR

Retrospective TMR

Participants with a history of major limb amputation that underwent primary or secondary TMR with attending plastic surgeon at UW

Procedure: Primary TMR; Procedure: Secondary TMR

Prospective Secondary TMR

Participants who are scheduled to undergo secondary TMR at the UW

Procedure: Secondary TMR

Prospective Primary TMR

Participants who are scheduled to undergo primary TMR at the UW

Procedure: Primary TMR

Interventions

Primary TMR PROCEDURE

TMR procedure as part of the primary major limb amputation surgery

Prospective Primary TMR; Retrospective TMR

Secondary TMR PROCEDURE

TMR procedure subsequent to major limb amputation surgery

Prospective Secondary TMR; Retrospective TMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that have undergone (retrospective) or are scheduled to undergo (prospective) major limb amputation with primary or secondary TMR procedure at the UW. A control group of participants that have had major limb amputation at the UW without the TMR procedure will also be surveyed.

You may qualify if:

• Retrospective
• Underwent primary or secondary TMR with attending plastic surgeon at UW
• Prospective
• Patient with history of major limb amputation who is scheduled to undergo secondary TMR with attending plastic surgeon at UW
• Patient who is scheduled to undergo primary major limb amputation with concurrent TMR
• Patient with history of major limb amputation recruited from local clinics who has not been referred or seen for consultation for TMR by attending plastic surgeon at UW

You may not qualify if:

• Retrospective
• Patient underwent TMR at another institution
• Less than 6 months follow up
• Less than 18 years of age
• Enrolled in other studies relating to neuropathic pain
• Undergoing radiation therapy
• Incarcerated
• Incomplete survey response
• Non-English speaking (chosen PROMIS measures only in English)
• Prospective
• Less than 18 years of age
• Cognitive impairment
• Enrolled in other studies relating to neuropathic pain
• Undergoing radiation therapy
• Incarcerated

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Officials

• Brett F Michelotti, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: December 29, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)