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

NCT ID: NCT00612391

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2020-11-30

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

Conditions

Closed Fracture Proximal Humerus, Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lateral, Minimally Invasive Approach

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

Group Type: EXPERIMENTAL

Lateral minimally invasive approach (plate fixation)

Intervention Type: PROCEDURE

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:

Deltopectoral approach for GT fracture treated operatively

Group Type: ACTIVE_COMPARATOR

Deltopectoral approach (plate fixation)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Dominique Rouleau

Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dominique M Rouleau, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Sacré-Coeur

Locations

Hopital Sacré-Coeur

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

HURA1

Identifier Type: -

Identifier Source: org_study_id