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

Not Applicable

Completed

• Conditions: Closed Fracture Proximal Humerus, Neck
• Interventions: Procedure: Deltopectoral approach (plate fixation); Procedure: Lateral minimally invasive approach (plate fixation)

• Registration Number: NCT00612391
• Lead Sponsor: Université de Montréal

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-29
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-11
• Primary Completion: 2019-07
• Study Completion: 2020-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deltopectoral approach:	Deltopectoral approach (plate fixation)	Deltopectoral approach for GT fracture treated operatively
Lateral, Minimally Invasive Approach	Lateral minimally invasive approach (plate fixation)	Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws)

Primary Outcome Measures

Name	Time	Method
Quick DASH	3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hopital Sacré-Coeur; 🇨🇦 Montreal, Quebec, Canada