Clinical trial NCT00612391: Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture
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
Overall status: COMPLETED
Phase: NA
Conditions: Closed Fracture Proximal Humerus, Neck
Keywords: humerus fracture
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Hopital du Sacre-Coeur de Montreal
First posted: 2008-02-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Quick DASH
timeFrame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
Secondary outcomes:
measure: SF-12V2 Questionnaire Constant Shoulder Score The Patient Scar Assessment Scale Complication rate
timeFrame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Sacré-Coeur
state: Quebec
Study officials:
affiliation: Hopital Sacré-Coeur
name: Dominique M Rouleau, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.