Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

NCT01051869 | Completed

• 1 other identifier: Ulnar Nerve 06-Jan-10
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Humeral Fractures; Ulnar Nerve Compression

Keywords

distal humerus; fractures; ulnar nerve; simple decompression; anterior transposition

Outcome Measures

Primary Outcomes (1)

• 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).

  1 Year

Secondary Outcomes (1)

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

  1 Year

Study Arms (2)

simple decompression

ACTIVE COMPARATOR

Procedure: Simple decompression

anterior subcutaneous transposition

ACTIVE COMPARATOR

Procedure: anterior subcutaneous transposition

Interventions

Simple decompression PROCEDURE

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.

simple decompression

anterior subcutaneous transposition PROCEDURE

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.

anterior subcutaneous transposition

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

MeSH Terms

Conditions

Humeral Fractures; Ulnar Nerve Compression Syndromes; Fractures, Bone

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Ulnar Neuropathies; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains

Study Officials

• Emil H Schemitsch, MD, FRCS(C)

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2010
• First Posted: January 20, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2019
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CA (1)