Distal Humerus FractureNCT03833414
Does Surgical-approach Affect Outcome After Fixation of Intra-articular Fractures of Distal Humerus?
An observational study of Distal Humerus Fracture, run by Aga Khan University.
Trial summary
observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate the difference between two common surgical approaches to distal humerus fracture fixation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Distal Humerus Fracture
- What is being tested?
- triceps lifting and olecranon osteotomy approaches
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all adult patients males and females who met the eligibility criteria.
Who may be able to join
- All patients >18 years of age with closed complex intra-articular distal humerus fracture (Intercondylar Fracture Riseborough Radin Classification type lll and lV) were included.
Who cannot join
- Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded
About this study
Official title: Surgical Approach for Distal Humerus Fracture
observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate the difference between two common surgical approaches to distal humerus fracture fixation.
Read the detailed description
Fractures around the distal humerus fractures make up to 2% of all fractures. Complex intra-articular distal humerus fractures present as challenge to restore of painless, stable and mobile elbow joint. Surgical exposure to all critical structures is of paramount importance to achieve anatomic reduction. Conflict still persists regarding the choice of ideal approach between triceps-sparing approach compared with olecranon osteotomy approach. In this study investigators compare the effect of surgical approach triceps lifting vs olecranon osteotomy on the functional outcome after fixation of distal humerus intra-articular fractures. Investigators conducted a non-funded, non-commercial, retrospective cohort study on participants with closed distal humerus intra-articular fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital. Participants >18 years of age with closed complex intra-articular distal humerus fracture were operated using two different surgical approaches, either triceps lifting approach (Group1) or with olecranon osteotomy (Group 2). Functional evaluation of the participant is carried out with quick DASH scores at the final 1 year follow-up. Investigators concluded that triceps lifting approach can be used equally efficiently for exposure of these complex distal humerus injuries with no comprise in visibility of articular fragments.
- Conditions
- Distal Humerus Fracture
- Being tested
- triceps lifting and olecranon osteotomy approaches
- Keywords
- intra-articular fractures; distal humerus; osteotomy; elbow joint
- Medical subject headings
- Humeral Fractures, Distal, Intra-Articular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triceps lifting and olecranon osteotomy approachesProcedure or surgery
two different surgical approaches for distal humerus fracture
| Study group | Role | What they receive |
|---|---|---|
| (Group1) | Triceps lifting approach . Receives: Procedure: triceps lifting and olecranon osteotomy approaches | |
| (Group 2) | olecranon osteotomy approach Receives: Procedure: triceps lifting and olecranon osteotomy approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome using Quick DASH Score
Disabilities of Arm, Shoulder \& Hand
Measured: 1 years followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study startJan 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Humerus FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aziz Hayder, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833414
- Sponsor's protocol ID
- 3799-Sur-ERC-15
- Status last verified
- Feb 2019
- First submitted
- 6 Feb 2019
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed according to hospital policy
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Approach for Distal Humerus Fracture
- ClinicalTrials.gov ID
- NCT03833414
- Acronym / sponsor ID
- 3799-Sur-ERC-15
- Conditions
- Distal Humerus Fracture
- Keywords
- intra-articular fractures; distal humerus; osteotomy; elbow joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Feb 2019 (actual)
- 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.
observational study at tertiary care hospital and level 1 trauma centre aiming to evaluate the difference between two common surgical approaches to distal humerus fracture fixation.
Detailed description
Fractures around the distal humerus fractures make up to 2% of all fractures. Complex intra-articular distal humerus fractures present as challenge to restore of painless, stable and mobile elbow joint. Surgical exposure to all critical structures is of paramount importance to achieve anatomic reduction. Conflict still persists regarding the choice of ideal approach between triceps-sparing approach compared with olecranon osteotomy approach. In this study investigators compare the effect of surgical approach triceps lifting vs olecranon osteotomy on the functional outcome after fixation of distal humerus intra-articular fractures. Investigators conducted a non-funded, non-commercial, retrospective cohort study on participants with closed distal humerus intra-articular fractures between 2010 and 2015 at our tertiary care level-1 trauma and university hospital. Participants >18 years of age with closed complex intra-articular distal humerus fracture were operated using two different surgical approaches, either triceps lifting approach (Group1) or with olecranon osteotomy (Group 2). Functional evaluation of the participant is carried out with quick DASH scores at the final 1 year follow-up. Investigators concluded that triceps lifting approach can be used equally efficiently for exposure of these complex distal humerus injuries with no comprise in visibility of articular fragments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group1) | – | Procedure: triceps lifting and olecranon osteotomy approachesTriceps lifting approach . |
| (Group 2) | – | Procedure: triceps lifting and olecranon osteotomy approachesolecranon osteotomy approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all adult patients males and females who met the eligibility criteria.
Key inclusion criteria (1 listed)
- All patients >18 years of age with closed complex intra-articular distal humerus fracture (Intercondylar Fracture Riseborough Radin Classification type lll and lV) were included.
Key exclusion criteria (1 listed)
- Patients with CVA (Cerebero-Vascular Accident), dementia and associated with neurovascular injuries which may impede with rehabilitation are excluded
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 |
|---|---|---|
| triceps lifting and olecranon osteotomy approachestwo different surgical approaches for distal humerus fracture | Procedure or surgery | (Group 2), (Group1) |
Primary outcome
Functional outcome using Quick DASH Score
Time frame: 1 years followup
Disabilities of Arm, Shoulder \& Hand
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 8 Feb 2019.
- Individual participant dataSharing planned: No. not allowed according to hospital policy
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Humerus Fracture, run by Aga Khan University.
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 1 inclusion and 1 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Functional outcome using Quick DASH Score (time frame: 1 years followup). 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 8 Feb 2019.