An interventional study of Lateral minimally invasive approach (plate fixation) and Deltopectoral approach (plate fixation) in Closed Fracture Proximal Humerus, Neck, sponsored by Université de Montréal. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Université de Montréal · Not applicable, Interventional, and Treatment
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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
106 studies on the registry are indexed under Humeral Fractures; 20 are open to participants now.
This study's enrollment of 79 is above the median of 56 across 64 interventional studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →Université de Montréal is the lead sponsor of 98 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Lateral, Minimally Invasive Approach in GT fractures treated operatively (plates and screws)
Procedure: Lateral minimally invasive approach (plate fixation)
Deltopectoral approach for GT fracture treated operatively
Procedure: Deltopectoral 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.
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.
Quick DASH
Time frame: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months.
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.
The record gives a start of Nov 2007, a primary completion of Jul 2019 and a completion of Nov 2020. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Université de Montréal