Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

Humeral Fractures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051869
• Other study ID #: Ulnar Nerve 06-Jan-10
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: September 2019

Study information

• Verified date: April 2020
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Ulnar Nerve Compression

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcome measurement will include a patient-oriented, limb-specific, functional measurement questionnaire (Disabilities of the Arm, Shoulder and Hand Instrument-DASH)		1 Year