ClinicalTrials.Veeva

Menu

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

U

University of Sao Paulo

Status

Completed

Conditions

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

Treatments

Device: Locked plate
Device: Intramedullary locked nail

Study type

Interventional

Funder types

Other

Identifiers

NCT01984112
0232/11

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

72 participants in 2 patient groups

Intramedullary Locked Nail
Experimental group
Treatment:
Device: Intramedullary locked nail
Locked Plate
Active Comparator group
Treatment:
Device: Locked plate

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems