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

Wounds and Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984112
• Other study ID #: 0232/11
• Status: Completed
• Phase: N/A
• First received: October 28, 2013
• Last updated: October 2, 2015
• Start date: May 2011
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Locked plate
Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture
• Intramedullary locked nail
Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture

Locations

Country	Name	City	State
Brazil	Instituto de Ortopedia e Traumatologia	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-operative integrity of the rotator cuff, evaluated by ultrasonography	Post-operative integrity of the rotator cuff, evaluated by ultrasonography	6 months	No
Primary	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	No
Secondary	Superior limb function, measured by DASH score	Disability of Arm-Shoulder-Hand score	12 months	No
Secondary	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	12 months	No
Secondary	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.	12 months	No
Secondary	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;	12 months	Yes