Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture (HURA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Université de Montréal
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Sherbrooke
Hopital du Sacre-Coeur de Montreal
Information provided by (Responsible Party):
Dominique Rouleau, Université de Montréal
ClinicalTrials.gov Identifier:
NCT00612391
First received: January 29, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
Closed Fracture Proximal Humerus, Neck
Procedure: Lateral minimally invasive approach (plate fixation)
Procedure: Deltopectoral approach (plate fixation)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • Quick DASH [ Time Frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: November 2007
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lateral, Minimally Invasive Approach
Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws)
Procedure: 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.
Active Comparator: Deltopectoral approach:
Deltopectoral approach for GT fracture treated operatively
Procedure: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Humeral surgical neck fracture, Neer II valgus-type Neer III
  2. Patient willing to participate in the study
  3. Patient available for follow-up through at least two years
  4. Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk
  5. Patient fluent in French and/or English and able to understand his/her role in the study

Exclusion Criteria:

  1. Inflammatory arthritis
  2. Prior shoulder pathology
  3. Active local or systemic infection
  4. Neurologic or musculoskeletal disease that may adversely affect mobility
  5. Participation in any other pharmaceutical, biologic or medical-device clinical investigation
  6. Severe documented psychiatric disease
  7. Severe ipsilateral elbow or wrist disease
  8. Fracture resistant to reduction attempts through the minimally invasive lateral approach
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612391

Contacts
Contact: Karine Tardif, TRP 514-338-2222 ext 3465 karinetardif2@gmail.com
Contact: George-Yves laflamme, MD 514-338-2050 orthofac@videotron.ca

Locations
Canada, Quebec
Hopital Sacré-Coeur Recruiting
Montreal, Quebec, Canada, H4J1C5
Principal Investigator: Dominique M Rouleau, MD         
Sponsors and Collaborators
Université de Montréal
Centre Hospitalier Universitaire de Sherbrooke
Hopital du Sacre-Coeur de Montreal
Investigators
Principal Investigator: Dominique M Rouleau, MD Hopital Sacré-Coeur
  More Information

No publications provided

Responsible Party: Dominique Rouleau, Orthopaedic surgeon, Université de Montréal
ClinicalTrials.gov Identifier: NCT00612391     History of Changes
Other Study ID Numbers: HURA1
Study First Received: January 29, 2008
Last Updated: August 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by Université de Montréal:
humerus fracture

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Humeral Fractures
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014