- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612391
Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture (HURA)
April 29, 2021 updated by: Dominique Rouleau, Université de Montréal
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4J1C5
- Hopital Sacre-Coeur
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lateral, Minimally Invasive Approach
Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws)
|
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.
|
Active Comparator: Deltopectoral approach:
Deltopectoral approach for GT fracture treated operatively
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quick DASH
Time Frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
|
3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dominique M Rouleau, MD, Hopital Sacre-Coeur
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
July 1, 2019
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
January 29, 2008
First Submitted That Met QC Criteria
February 8, 2008
First Posted (Estimate)
February 11, 2008
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 29, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HURA1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Closed Fracture Proximal Humerus, Neck
-
Mayo ClinicTerminatedClosed Fracture Proximal Humerus, Four PartUnited States
-
AO Clinical Investigation and Publishing DocumentationCompletedHumerus Fractures | Closed Fracture of the Proximal HumerusBelgium, Austria, Germany, Switzerland
-
Prof. Dr. Cemil Tascıoglu Education and Research...CompletedPatients With Closed Neer Type 4 Proximal Humerus FracturesTurkey
-
Johns Hopkins UniversityUniversity of Texas Southwestern Medical CenterCompletedOsteoarthritis | Shoulder Pain | Arthropathy | Closed Fracture Proximal Humerus, Four PartUnited States
-
Synthes GmbHCompletedClosed Proximal Tibial Fracture Schatzker I - VI | Closed Proximal Tibial Fracture AO-OTA 41 | Closed Proximal Tibial Fracture AO-OTA 42Korea, Republic of
-
Technische Universität DresdenActive, not recruitingProximal Humerus FractureGermany
-
University Hospital, AkershusRecruitingProximal Humerus Fracture | 2 Part FractureNorway
-
Aga Khan University Hospital, PakistanNot yet recruitingTrauma | Proximal Humerus Fracture
-
Royal Infirmary of EdinburghUniversity of Edinburgh; NHS LothianCompleted
-
Ottawa Hospital Research InstituteTerminated
Clinical Trials on Lateral minimally invasive approach (plate fixation)
-
Assiut UniversityCompletedCalcaneus FractureEgypt
-
Second Affiliated Hospital, School of Medicine,...The First People's Hospital of Huzhou; Taizhou Hospital; Ningbo No.2 HospitalNot yet recruiting
-
Medacta International SACompletedOsteoarthritis | Rheumatoid ArthritisUnited Kingdom
-
King Abdullah International Medical Research CenterUnknown
-
Sohag UniversityRecruitingUnstable Pelvic FracturesEgypt
-
Medacta International SACompletedArthritis | Osteoarthritis | Avascular Necrosis | Congenital Hip Dysplasia | Fracture of the Femoral Neck or HeadGermany
-
Assiut UniversityUnknownPeriareolar Minimally Invasive Cardiac Surgery
-
Aarhus University HospitalCompleted
-
Sahlgrenska University Hospital, SwedenCompletedRib; Fracture, Multiple, With Flail ChestSweden
-
Orthopedic Hospital Vienna SpeisingCompletedTotal Hip ArthroplastyAustria