NCT01557413

Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures

Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Primary purpose of this study was to compare functional outcomes after displaced and proximal humerus fracture between nails and locked plates. The hypothesis is that intramedullary nails provides satisfactory fixation and functional outcome compared to locked plate.

Detailed description

: Proximal humerus fractures have a higher occurrence in elderly patients and therefore represent a public health problem. Prognosis depends on greater and lesser tuberosity status, where rotator tendons of the shoulder have their insertion site. Surgical treatment is recommended in case of tuberosities displacement. Goals are their anatomic reduction and stable primary fixation that will allow good bone healing and early mobilization. It has been demonstrated that an extended immobilization can result in stiffness by capsular retraction. On the contrary a too early mobilization can lead to secondary displacement of tuberosities and malunion. These sequelae can be responsible for real disability when occuring in active patients, in particular when dominant limb is affected. Internal fixation by locking intramedullary nails is currently the first choice technique because less invasive. However it doesn't always provide a good bone fixation, leading to tuberosities displacement or longer immobilization that decrease shoulder function prognosis. Locking plates represent a good alternative to avoid these complications by offering a better fixation of tuberosities in osteoporotic bone. Though there is no existing randomised study comparing these techniques regarding functional outcomes, complications rates, and patient satisfaction.

Conditions

• Proximal Humerus Fractures

Interventions

Type	Name	Description
PROCEDURE	Intramedullary nail	the fracture was reduced and fix by an intramedullary humeral nail (Multilock, SYNTHES, Switzerland) using an open surgery. An anterolateral approach will be performed, the patient sit in beach chair position under general anesthesia. If required additional sutures will be authorized to fix the tuberosities.
PROCEDURE	Locked plate	the fracture was reduced and fix by a locking plate using an open surgery (SURFIX, Integra, France). A deltopectoral approach will be performed, the patient sit in beach position under general anesthesia. If required, additional sutures will be authorized to fix the tuberosities.

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2012-03-19
• Last updated: 2017-02-23

Locations

1 site across 1 country: France