NCT03579277

Brief Summary

This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

5.5 years

First QC Date

January 24, 2018

Last Update Submit

August 28, 2023

Conditions

Free Tissue Flaps

Keywords

Radial Forearm Free FlapUlnar Forearm Free FlapFree Tissue Transfer

Outcome Measures

Primary Outcomes (5)

  • Average Grip Strength (lbs) in the operative hand and non-operative hand

    Subjects' grip strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied by the hand to a Jamar Dynometer in pounds.

    up to 6 months

  • Average Key Pinch Strength (lbs) in the operative hand and non-operative hand

    Subjects' pinch strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied with key pinch in pounds.

    up to 6 months

  • Average Physician and Patient Rating of Scar Appearance

    Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10.

    up to 6 months

  • Aggregated Brief Michigan Hand Questionnaire results (composite score)

    Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100.

    up to 6 months

  • Average Static Two Point Discrimination (mm)

    Subjects' static two point discrimination threshold in their finger pads, palm, and dorsum of the hand, in the operative and non-operative extremity, each measured in millimeters.

    up to 6 months

Secondary Outcomes (12)

  • Number of patients with complete flap loss

    up to 6 months

  • Number of patients with partial flap loss

    up to 6 months

  • Number of patients reporting cold intolerance

    up to 6 months

  • Number of patients reporting neuropathy

    up to 6 months

  • Number of patients with postoperative hematoma at donor site

    up to 6 months

  • +7 more secondary outcomes

Study Arms (2)

Radial forearm free flap

ACTIVE COMPARATOR

Subjects in this arm will receive a radial forearm free flap.

Procedure: Radial Forearm Free Flap

Ulnar forearm free flap

ACTIVE COMPARATOR

Subjects in this arm will receive an ulnar forearm free flap.

Procedure: Ulnar Forearm Free Flap

Interventions

Radial Forearm Free FlapPROCEDURE

Subjects in this arm will undergo a radial forearm free flap.

Radial forearm free flap
Ulnar Forearm Free FlapPROCEDURE

Subjects in this arm will undergo an ulnar forearm free flap.

Ulnar forearm free flap

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with planned forearm free flap reconstruction
  • Patients who are deemed equal surgical candidates for radial forearm free flap and ulnar forearm free flap reconstruction
  • Preoperative Allen's test completed and passed
  • Patients have the capacity to complete the informed consent process

You may not qualify if:

  • Patients that are not candidates for a forearm flap based on their physiology
  • Clinically evident peripheral neuropathy (e.g., diabetic neuropathy, leprosy)
  • Patients requiring concurrent forearm bone for reconstruction
  • Child, prisoner, or other vulnerable group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Study Officials

  • Joshua Adkinson, M.D.

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
To the extend possible based on the nature of the study, subjects and researchers will be masked from the treatment arms.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects are assigned to one of two treatment arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Hand Surgery

Study Record Dates

First Submitted

January 24, 2018

First Posted

July 6, 2018

Study Start

January 1, 2018

Primary Completion

July 15, 2023

Study Completion

August 15, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

US(1)