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Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

Primary Purpose

Humeral Fractures, Ulnar Nerve Compression

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Simple decompression
anterior subcutaneous transposition
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fractures focused on measuring distal humerus, fractures, ulnar nerve, simple decompression, anterior transposition

Eligibility Criteria

16 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men or women aged 16 to 60 years of age
  • Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
  • Fractures ≤ 28 days post injury
  • Closed fractures
  • No history of previous ulnar neuropathy or elbow pathology
  • Provisin of informed consent

Exclusion Criteria:

  • Vascular injury
  • History of previous ulnar neuropathy or elbow pathology
  • Fractures more than 28 days post-injury
  • Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
  • Inability to comply with rehabilitation or form completion
  • Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

simple decompression

anterior subcutaneous transposition

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome will be signs of ulnar neuropathy, measured using two clinical staging systems to assess the degree of dysfunction of the ulnar nerve (the classification system of Gabel and Amadio13).

Secondary Outcome Measures

Secondary outcome measurement will include a patient-oriented, limb-specific, functional measurement questionnaire (Disabilities of the Arm, Shoulder and Hand Instrument-DASH)

Full Information

First Posted
January 18, 2010
Last Updated
April 23, 2020
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01051869
Brief Title
Simple Decompression Versus Anterior Transposition of the Ulnar Nerve
Official Title
A Multicentre, Randomized Trial of Simple Decompression Versus Anterior Transposition of the Ulnar Nerve for Acute, Displaced Fractures of the Distal Humerus Treated With Plate Fixation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for acute displaced fractures of the elbow (distal humerus) treated with plate fixation are currently used by surgeons. We want to examine which treatment will overall give better results in regards to arm function and residual pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures, Ulnar Nerve Compression
Keywords
distal humerus, fractures, ulnar nerve, simple decompression, anterior transposition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
simple decompression
Arm Type
Active Comparator
Arm Title
anterior subcutaneous transposition
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Simple decompression
Intervention Description
Fracture fixation will be performed through a posterior approach, as this provides excellent visualization of the distal fragments. A triceps split will be used to expose the distal humerus. A midline incision will be made from proximally to distal onto the shaft of the ulna. Equal portions of the triceps muscle will be reflected medially and laterally, with use of sharp dissection to remove the triceps insertion from the olecranon. The ulnar nerve will be identified and protected proximal and distal to the medial epicondyle. Fracture fixation will be performed after anatomic reduction using standard fixation techniques and plate fixation on both the medial and lateral column. In the simple ulnar nerve decompression group, no further treatment of the ulnar nerve will be undertaken.
Intervention Type
Procedure
Intervention Name(s)
anterior subcutaneous transposition
Intervention Description
In the anterior transposition of the ulnar nerve group, the ulnar nerve will be placed subcutaneously anterior to the medial epicondyle free from any pressure.
Primary Outcome Measure Information:
Title
The primary outcome will be signs of ulnar neuropathy, measured using two clinical staging systems to assess the degree of dysfunction of the ulnar nerve (the classification system of Gabel and Amadio13).
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Secondary outcome measurement will include a patient-oriented, limb-specific, functional measurement questionnaire (Disabilities of the Arm, Shoulder and Hand Instrument-DASH)
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men or women aged 16 to 60 years of age Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs Fractures ≤ 28 days post injury Closed fractures No history of previous ulnar neuropathy or elbow pathology Provisin of informed consent Exclusion Criteria: Vascular injury History of previous ulnar neuropathy or elbow pathology Fractures more than 28 days post-injury Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery Inability to comply with rehabilitation or form completion Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emil H Schemitsch, MD, FRCS(C)
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 1R6
Country
Canada

12. IPD Sharing Statement

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Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

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