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

Primary Purpose

Closed Fracture Proximal Humerus, Neck

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lateral minimally invasive approach (plate fixation)

Deltopectoral approach (plate fixation)

About this trial

This is an interventional treatment trial for Closed Fracture Proximal Humerus, Neck focused on measuring humerus fracture

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Sacré-Coeur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lateral, Minimally Invasive Approach

Deltopectoral approach:

Arm Description

Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws)

Deltopectoral approach for GT fracture treated operatively

Outcomes

Primary Outcome Measures

Quick DASH

Secondary Outcome Measures

SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate

Full Information

NCT ID

NCT00612391

First Posted

January 29, 2008

Last Updated

April 29, 2021

Sponsor

Université de Montréal

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Hopital du Sacre-Coeur de Montreal

1. Study Identification

Unique Protocol Identification Number

NCT00612391

Brief Title

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

Acronym

HURA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

July 2019 (Actual)

Study Completion Date

November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Université de Montréal

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Hopital du Sacre-Coeur de Montreal

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Closed Fracture Proximal Humerus, Neck

Keywords

humerus fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lateral, Minimally Invasive Approach

Arm Type

Experimental

Arm Description

Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws)

Arm Title

Deltopectoral approach:

Arm Type

Active Comparator

Arm Description

Deltopectoral approach for GT fracture treated operatively

Intervention Type

Procedure

Intervention Name(s)

Lateral minimally invasive approach (plate fixation)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Deltopectoral approach (plate fixation)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Quick DASH

Time Frame

3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique M Rouleau, MD

Organizational Affiliation

Hopital Sacré-Coeur

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Sacré-Coeur

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J1C5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

35727196

Citation

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.

Results Reference

derived

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

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