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NCT Number: NCT01984112

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

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.

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Key information

Conditions

Humerus Arm Injuries Fractures, Bone Humeral Fractures Proximal Humeral Fracture Shoulder Fractures Shoulder Injuries Wounds and Injuries

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Ortopedia e Traumatologia

São Paulo, 05403-010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Locked plate

Device

Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture

Other names: Philos plaste, Synthes, Switzerland

Intramedullary locked nail

Device

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

Primary outcomes

  1. 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

  1. Superior limb function, measured by DASH score

    Time frame: 12 months

    Disability of Arm-Shoulder-Hand score

  2. Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score

    Time frame: 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

  3. Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score

    Time frame: 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.

  4. Number of patients with complications

    Time frame: 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;

Other outcomes

  1. Post-operative integrity of the rotator cuff, evaluated by ultrasonography

    Time frame: 6 months

    Post-operative integrity of the rotator cuff, evaluated by ultrasonography

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2013
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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