Closed Fracture Proximal Humerus, NeckHURANCT00612391
Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture
A study testing Lateral minimally invasive approach (plate fixation) and Deltopectoral approach (plate fixation) in people with Closed Fracture Proximal Humerus, Neck, run by Université de Montréal at 1 site in Canada.
Trial summary
A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Closed Fracture Proximal Humerus, Neck
- What is being tested?
- Lateral minimally invasive approach (plate fixation) and Deltopectoral approach (plate fixation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to Nov 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Humeral surgical neck fracture, Neer II valgus-type Neer III
- Patient willing to participate in the study
- Patient available for follow-up through at least two years
- Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk
- Patient fluent in French and/or English and able to understand his/her role in the study
Who cannot join
- Inflammatory arthritis
- Prior shoulder pathology
- Active local or systemic infection
- Neurologic or musculoskeletal disease that may adversely affect mobility
- Participation in any other pharmaceutical, biologic or medical-device clinical investigation
- Severe documented psychiatric disease
- Severe ipsilateral elbow or wrist disease
- Fracture resistant to reduction attempts through the minimally invasive lateral approach
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures
A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. The trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. The Quick DASH will be used for evaluation of function.The study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years
- Conditions
- Closed Fracture Proximal Humerus, Neck
- Being tested
- Lateral minimally invasive approach (plate fixation), Deltopectoral approach (plate fixation)
- Keywords
- humerus fracture
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral minimally invasive approach (plate fixation)Procedure or surgery
A longitudinally oriented, 4-cm incision will be made laterally starting at the acromion. The deltoid will be split proximally at the most strategic location (vis-à-vis the fracture), and after the deltoid is bluntly elevated from the humerus more distally the axillary nerve will be identified by digital palpation. The nerve is easily identified posteriorly as it emerges from the quadrilateral space. With a finger maintained on the nerve for protection, the plate will be inserted onto the lateral side of the proximal humerus and fixed according to the described technique. A second, 2-cm longitudinal incision will then be made further distally for diaphyseal screw placement. This incision is well distal to the course of the axillary nerve.
Deltopectoral approach (plate fixation)Procedure or surgery
Anterior, Delto-Pectoral Approach - A 10-cm incision will be made over the deltopectoral groove, starting at the coracoid process proximally. As the clavipectoral fascia is incised, the cephalic vein will be identified and retracted laterally with the deltoid muscle. The pectoralis major as well as the conjoint tendon will be retracted medially, and the long head of the biceps tendon will be identified and used as a guide for achieving an anatomic reduction of the different fracture parts. Next, internally rotating the humerus will allow access to the lateral side of the proximal humerus, on which the plate will then be fixed according to the described technique.
| Study group | Role | What they receive |
|---|---|---|
| Lateral, Minimally Invasive Approach | Experimental | Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws) Receives: Procedure: Lateral minimally invasive approach (plate fixation) |
| Deltopectoral approach: | Active comparator | Deltopectoral approach for GT fracture treated operatively Receives: Procedure: Deltopectoral approach (plate fixation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick DASH
Measured: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
Secondary outcomes (1)
SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate
Measured: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2019
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Closed Fracture Proximal Humerus, NeckStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Responsible party
- Principal investigator, Dominique Rouleau, Université de Montréal
- Investigators
- Dominique M Rouleau, MD, Principal investigator, Hopital Sacré-Coeur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612391
- Sponsor's protocol ID
- HURA1
- Acronym
- HURA
- Status last verified
- Apr 2021
- First submitted
- 29 Jan 2008
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PubMed 35727196
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT00612391
- Acronym / sponsor ID
- HURA / HURA1
- Conditions
- Closed Fracture Proximal Humerus, Neck
- Keywords
- humerus fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Study start
- Nov 2007
- Primary completion
- Jul 2019 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 11 Feb 2008 (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.
A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. The trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. The Quick DASH will be used for evaluation of function.The study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral, Minimally Invasive Approach | Experimental | Procedure: Lateral minimally invasive approach (plate fixation)Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws) |
| Deltopectoral approach: | Active comparator | Procedure: Deltopectoral approach (plate fixation)Deltopectoral approach for GT fracture treated operatively |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Humeral surgical neck fracture, Neer II valgus-type Neer III
- Patient willing to participate in the study
- Patient available for follow-up through at least two years
- Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk
- Patient fluent in French and/or English and able to understand his/her role in the study
Key exclusion criteria (8 listed)
- Inflammatory arthritis
- Prior shoulder pathology
- Active local or systemic infection
- Neurologic or musculoskeletal disease that may adversely affect mobility
- Participation in any other pharmaceutical, biologic or medical-device clinical investigation
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 |
|---|---|---|
| Lateral minimally invasive approach (plate fixation)A longitudinally oriented, 4-cm incision will be made laterally starting at the acromion. The deltoid will be split proximally at the most strategic location (vis-à-vis the fracture), and after the deltoid is bluntly elevated from the humerus more distally the axillary nerve will be identified by digital palpation. The nerve is easily identified posteriorly as it emerges from the quadrilateral space. With a finger maintained on the nerve for protection, the plate will be inserted onto the lateral side of the proximal humerus and fixed according to the described technique. A second, 2-cm longitudinal incision will then be made further distally for diaphyseal screw placement. This incision is well distal to the course of the axillary nerve. | Procedure or surgery | Lateral, Minimally Invasive Approach |
| Deltopectoral approach (plate fixation)Anterior, Delto-Pectoral Approach - A 10-cm incision will be made over the deltopectoral groove, starting at the coracoid process proximally. As the clavipectoral fascia is incised, the cephalic vein will be identified and retracted laterally with the deltoid muscle. The pectoralis major as well as the conjoint tendon will be retracted medially, and the long head of the biceps tendon will be identified and used as a guide for achieving an anatomic reduction of the different fracture parts. Next, internally rotating the humerus will allow access to the lateral side of the proximal humerus, on which the plate will then be fixed according to the described technique. | Procedure or surgery | Deltopectoral approach: |
Primary outcome
Quick DASH
Time frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
1 secondary outcome
SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate
Time frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
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 30 Apr 2021.
- Derived from this study: PubMed 35727196Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
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.
Dominique M Rouleau, MD principal investigator
Hopital Sacré-Coeur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral minimally invasive approach (plate fixation) and Deltopectoral approach (plate fixation) in people with Closed Fracture Proximal Humerus, Neck, run by Université de Montréal 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 5 inclusion and 8 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 30 Apr 2021. 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?
Quick DASH (time frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00612391, which also lists 1 linked publication.
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 30 Apr 2021.