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Simple Decompression Versus Anterior Transposition of the Ulnar Nerve

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ClinicalTrials.gov Identifier: NCT01051869
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE January 18, 2010
First Posted Date  ICMJE January 20, 2010
Last Update Posted Date September 12, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01051869 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simple Decompression Versus Anterior Transposition of the Ulnar Nerve
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Humeral Fractures
  • Ulnar Nerve Compression
Intervention  ICMJE
  • 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.

  • 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.
Study Arms  ICMJE
  • Active Comparator: simple decompression
    Intervention: Procedure: Simple decompression
  • Active Comparator: anterior subcutaneous transposition
    Intervention: Procedure: anterior subcutaneous transposition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)
56
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2010)
54
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01051869
Other Study ID Numbers  ICMJE Ulnar Nerve 06-Jan-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emil H Schemitsch, MD, FRCS(C) St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP