Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

This study is currently recruiting participants.
Verified July 2013 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
Emil Schemitsch, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01051869
First received: January 18, 2010
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Humeral Fractures
Ulnar Nerve Compression
Procedure: Simple decompression
Procedure: anterior subcutaneous transposition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

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). [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

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) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: September 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: simple decompression Procedure: Simple decompression

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.

Active Comparator: anterior subcutaneous transposition Procedure: anterior subcutaneous transposition
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.

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01051869

Contacts
Contact: Emil Schemitsch, MD, FRCS(C) 416-864-6060 ext 6003

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5C 1R6
Contact: Milena Vicente, RN    416-864-6060 ext 2608    vicentem@smh.ca   
Principal Investigator: Emil Schemitsch, MD. ,FRCS(C)         
Sub-Investigator: Michael D McKee, MD., FRCS(C)         
Principal Investigator: Jeremy A Hall, MD.,FRCS(C)         
Sub-Investigator: Aaron Nauth, MD, FRCSC         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Emil H Schemitsch, MD, FRCS(C) St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Emil Schemitsch, MD, FRCS(C), St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01051869     History of Changes
Other Study ID Numbers: Ulnar Nerve 06-Jan-10
Study First Received: January 18, 2010
Last Updated: July 5, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
distal humerus
fractures
ulnar nerve
simple decompression
anterior transposition

Additional relevant MeSH terms:
Cumulative Trauma Disorders
Fractures, Bone
Humeral Fractures
Ulnar Nerve Compression Syndromes
Wounds and Injuries
Arm Injuries
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Sprains and Strains

ClinicalTrials.gov processed this record on April 14, 2014