NCT01984112

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 5, 2015

Status Verified

October 1, 2015

Enrollment Period

3.8 years

First QC Date

October 28, 2013

Last Update Submit

October 2, 2015

Conditions

HumerusProximal Humeral FractureFractures, BoneHumeral FracturesWounds and InjuriesArm Injuries

Keywords

Humerusfracturenailplatetuberosity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • Number of patients with complications

    12 months

Other Outcomes (1)

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

    6 months

Study Arms (2)

Intramedullary Locked Nail

EXPERIMENTAL
Device: Intramedullary locked nail

Locked Plate

ACTIVE COMPARATOR
Device: Locked plate

Interventions

Locked plateDEVICE

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

Also known as: Philos plaste, Synthes, Switzerland
Locked Plate
Intramedullary locked nailDEVICE

Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture

Also known as: Centronail, Proximal Humeral Nail, Orthofix, Italy
Intramedullary Locked Nail

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • Characteristics of the fracture:
  • fracture between the greater tubercle and the smaller, independent of the deviation;
  • Isolated fracture of the greater or lesser tuberosity
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Ortopedia e Traumatologia

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 35727196DERIVED

MeSH Terms

Conditions

Shoulder FracturesFractures, BoneHumeral FracturesWounds and InjuriesArm Injuries

Condition Hierarchy (Ancestors)

Shoulder Injuries

Study Officials

  • Mauro EC Gracitelli, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 28, 2013

First Posted

November 14, 2013

Study Start

May 1, 2011

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

October 5, 2015

Record last verified: 2015-10

Locations

BR(1)