Humeral FracturesNCT01051869
Simple Decompression Versus Anterior Transposition of the Ulnar Nerve
A study testing Simple decompression and anterior subcutaneous transposition in people with Humeral Fractures and Ulnar Nerve Compression, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Humeral Fractures, Ulnar Nerve Compression
- What is being tested?
- Simple decompression and anterior subcutaneous transposition
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Simple decompression, anterior subcutaneous transposition
- Keywords
- distal humerus, fractures, ulnar nerve, simple decompression, anterior transposition
- Medical subject headings
- Humeral Fractures, Ulnar Nerve Compression Syndromes, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple decompressionProcedure or surgery
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 transpositionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| simple decompression | Active comparator | Not described Receives: Procedure: Simple decompression |
| anterior subcutaneous transposition | Active comparator | Not described Receives: Procedure: anterior subcutaneous transposition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2018
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral FracturesStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emil H Schemitsch, MD, FRCS(C), Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051869
- Sponsor's protocol ID
- Ulnar Nerve 06-Jan-10
- Status last verified
- Apr 2020
- First submitted
- 18 Jan 2010
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01051869
- Acronym / sponsor ID
- Ulnar Nerve 06-Jan-10
- Conditions
- Humeral Fractures, Ulnar Nerve Compression
- Keywords
- distal humerus, fractures, ulnar nerve, simple decompression, anterior transposition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simple decompression | Active comparator | Procedure: Simple decompression |
| anterior subcutaneous transposition | Active comparator | Procedure: anterior subcutaneous transposition |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simple decompressionFracture 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 or surgery | simple decompression |
| anterior subcutaneous transpositionIn the anterior transposition of the ulnar nerve group, the ulnar nerve will be placed subcutaneously anterior to the medial epicondyle free from any pressure. | Procedure or surgery | anterior subcutaneous transposition |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil H Schemitsch, MD, FRCS(C) principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple decompression and anterior subcutaneous transposition in people with Humeral Fractures and Ulnar Nerve Compression, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.