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

Primary Purpose

Humerus, Proximal Humeral Fracture, Fractures, Bone

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Locked plate

Intramedullary locked nail

About this trial

This is an interventional treatment trial for Humerus focused on measuring Humerus, fracture, nail, plate, tuberosity

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Instituto de Ortopedia e Traumatologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intramedullary Locked Nail

Locked Plate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Superior limb function, measured by DASH score

Disability of Arm-Shoulder-Hand score

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

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

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

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;

Full Information

NCT ID

NCT01984112

First Posted

October 28, 2013

Last Updated

October 2, 2015

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01984112

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Humerus, fracture, nail, plate, tuberosity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intramedullary Locked Nail

Arm Type

Experimental

Arm Title

Locked Plate

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Locked plate

Other Intervention Name(s)

Philos plaste, Synthes, Switzerland

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Intramedullary locked nail

Other Intervention Name(s)

Centronail, Proximal Humeral Nail, Orthofix, Italy

Intervention Description

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

Primary Outcome Measure Information:

Title

Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score

Description

Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Superior limb function, measured by DASH score

Description

Disability of Arm-Shoulder-Hand score

Time Frame

12 months

Title

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

Description

Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by University of California Los Angeles score. 0-35 points score

Time Frame

12 months

Title

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

Description

Time Frame

12 months

Title

Number of patients with complications

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mauro EC Gracitelli, MD

Organizational Affiliation

University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Ortopedia e Traumatologia

City

São Paulo

State/Province

ZIP/Postal Code

05403-010

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

35727196

Citation

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.

Results Reference

derived

Learn more about this trial

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

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