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

Université de Montréal

Status: Completed

Conditions: Closed Fracture Proximal Humerus, Neck

Treatments: Procedure: Lateral minimally invasive approach (plate fixation); Procedure: Deltopectoral approach (plate fixation)

Study type: Interventional

Funder types: Other

Identifiers

NCT00612391

HURA1

Details and patient eligibility

About

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

Enrollment: 79 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

Lateral, Minimally Invasive Approach

Experimental group

Description:

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

Treatment:

Procedure: Lateral minimally invasive approach (plate fixation)

Deltopectoral approach:

Active Comparator group

Description:

Deltopectoral approach for GT fracture treated operatively

Treatment:

Procedure: Deltopectoral approach (plate fixation)