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Clinical Trials/NCT01984112
NCT01984112CompletedNot Applicable

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

University of Sao Paulo1 site in 1 country72 target enrollmentStarted: May 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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;

Arms & Interventions

Intramedullary Locked Nail

Experimental

Intervention: Intramedullary locked nail (Device)

Locked Plate

Active Comparator

Intervention: Locked plate (Device)

Outcomes

Primary Outcomes

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

  • Number of patients with complications(12 months)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mauro Gracitelli

MD

University of Sao Paulo

Study Sites (1)

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