Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture

Closed Fracture Proximal Humerus, Neck Clinical Trial

— HURA  

Official title:

A Randomized Clinical Trail Comparing a Lateral Minimally Invasive Approach and the Traditional Anterior Approach for Plating of Proximal Humerus Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612391
• Other study ID #: HURA1
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Est. completion date: November 2020

Study information

• Verified date: April 2021
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: November 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Closed Fracture Proximal Humerus, Neck
• Fractures, Bone
• Fractures, Closed
• Humeral Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hopital Sacré-Coeur	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Montréal	Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quick DASH		3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
Secondary	SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate		3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.