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

Not Applicable

Completed

• Conditions: Humerus; Proximal Humeral Fracture; Humeral Fractures; Wounds and Injuries; Arm Injuries; Fractures, Bone
• Interventions: Device: Locked plate; Device: Intramedullary locked nail

• Registration Number: NCT01984112
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-14
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-02
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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;

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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;
  • pathologic fractures;
  • lesions of the rotator cuff tendons previously diagnosed;
  • Psychiatric illnesses or inability to understand preoperative questionnaires;
  • Active infection or previous infection on the shoulder;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Locked Plate	Locked plate	-
Intramedullary Locked Nail	Intramedullary locked nail	-

Primary Outcome Measures

Name	Time	Method
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score	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 Outcome Measures

Name	Time	Method
Number of patients with complications	12 months	Overall complications and need for additional surgery, categorized as: Not related to implant; Clinical; * Death in the intraoperative or postoperative period; * Clinical complications related to surgery .; Orthopedic; * Infection; * Osteonecrosis ; * Nonunion ; * Stiffness; * Reflex sympathetic dystrophy ; * Heterotopic ossification ; * Refracture ; * Neurological injury .; * Insufficient reduction; * Loss of reduction of the humeral head; * Loss of reduction of tubercule: deviation greater than 5 mm between the immediate postoperative radiographs and 12 months; Related to the implant; * Primary articular protrusion of screws; * Loosening of the implant ; * Breaking of the implant ; * Cutout: loss reduction head with proximal screw pullout ; * secondary articular protrusion screws; * Malunion; * Injury to the rotator cuff tendons is observed in postoperative ultrasonography;
Superior limb function, measured by DASH score	12 months	Disability of Arm-Shoulder-Hand score
Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score	12 months	Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score.; 0-35 points score
Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score	12 months	Individual Relative Constant-Murley Score, compared to non-injured shoulder.; Fialka C, Oberleitner G, Stampfl P, Brannath W, Hexel M, Vécsei V. Modification of the Constant-Murley shoulder score-introduction of the individual relative Constant score Individual shoulder assessment. Injury. 2005 Oct;36(10):1159-65.

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia; 🇧🇷 São Paulo, SP, Brazil