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

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

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.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Fractures, Bone; Arm Injuries; Humeral Fractures; Proximal Humeral Fracture; Humerus
• Intervention / Treatment: Device: Intramedullary locked nail; Device: Locked plate

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-010
      • Instituto de Ortopedia e Traumatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
  • 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intramedullary Locked Nail	Device: Intramedullary locked nail; Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture; Other Names: Centronail, Proximal Humeral Nail, Orthofix, Italy
ACTIVE_COMPARATOR: Locked Plate	Device: Locked plate; Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture; Other Names: Philos plaste, Synthes, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score	Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superior limb function, measured by DASH score	Disability of Arm-Shoulder-Hand score	12 months
Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score	Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score. 0-35 points score	12 months
Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score	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.	12 months
Number of patients with complications	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;	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative integrity of the rotator cuff, evaluated by ultrasonography	Post-operative integrity of the rotator cuff, evaluated by ultrasonography	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Mauro EC Gracitelli, MD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): April 1, 2015

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (ESTIMATE): November 14, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 5, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: fracture; Humerus; nail; plate; tuberosity
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Fractures, Bone; Humeral Fractures; Arm Injuries; Shoulder Fractures
• Other Study ID Numbers: 0232/11