Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures

University of Sao Paulo1 site in 1 country72 target enrollmentMay 2011

ConditionsHumerus Proximal Humeral Fracture Fractures, Bone Humeral Fractures Wounds and Injuries Arm Injuries

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Humerus
Sponsor: University of Sao Paulo
Enrollment: 72
Locations: 1
Primary Endpoint: Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

April 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo

Responsible Party

Principal Investigator

Mauro Gracitelli

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

•Fracture with less than 21 days;
•Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;
•Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;
•Closed fractures;

Exclusion Criteria

•Characteristics of the fracture:
•fracture between the greater tubercle and the smaller, independent of the deviation;
•Isolated fracture of the greater or lesser tuberosity
•4-part fractures of Neer;
•Fracture involving the articular surface of the humeral head;
•Fracture-dislocation of the proximal humerus
•Other criteria:
•Neurological injuries in the affected limb;
•previous surgery on the affected shoulder;
•associated fractures in the affected limb;

Outcomes

Primary Outcomes

Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score

Time Frame: 12 months

Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome

Secondary Outcomes

Number of patients with complications(12 months)
Superior limb function, measured by DASH score(12 months)
Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score(12 months)
Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score(12 months)