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

NCT ID: NCT01984112

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intramedullary Locked Nail

Group Type: EXPERIMENTAL

Intramedullary locked nail

Intervention Type: DEVICE

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

Locked Plate

Group Type: ACTIVE_COMPARATOR

Locked plate

Intervention Type: DEVICE

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

Interventions

Locked plate

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

Intervention Type: DEVICE

Intramedullary locked nail

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

Intervention Type: DEVICE

Other Intervention Names

Philos plaste, Synthes, Switzerland; Centronail, Proximal Humeral Nail, Orthofix, Italy

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;

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mauro Gracitelli

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mauro EC Gracitelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Instituto de Ortopedia e Traumatologia

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35727196 (View on PubMed)

Other Identifiers

0232/11

Identifier Type: -

Identifier Source: org_study_id