Trial record 2 of 84 for:    Open Studies | "Arm Injuries"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Mauro Gracitelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01984112
First received: October 28, 2013
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Humerus
Proximal Humeral Fracture
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries
Device: Locked plate
Device: Intramedullary locked nail

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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:
  • Superior limb function, measured by DASH score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Disability of Arm-Shoulder-Hand score

  • Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


  • Number of patients with complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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 Outcome Measures:
  • Post-operative integrity of the rotator cuff, evaluated by ultrasonography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Post-operative integrity of the rotator cuff, evaluated by ultrasonography


Estimated Enrollment: 72
Study Start Date: May 2011
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Philos plaste, Synthes, Switzerland

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
    • 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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984112

Contacts
Contact: Mauro Gracitelli, MD 5511 26616600 mgracitelli@gmail.com

Locations
Brazil
Instituto de Ortopedia e Traumatologia Recruiting
São Paulo, SP, Brazil, 05403-010
Principal Investigator: Mauro EC Gracitelli, MD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Mauro EC Gracitelli, MD University of São Paulo
  More Information

No publications provided

Responsible Party: Mauro Gracitelli, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01984112     History of Changes
Other Study ID Numbers: 0232/11
Study First Received: October 28, 2013
Last Updated: November 7, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Humerus
fracture
nail
plate
tuberosity

Additional relevant MeSH terms:
Arm Injuries
Fractures, Bone
Humeral Fractures
Shoulder Fractures
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014