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

NCT ID: NCT01557413

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intramedullary nail

Intramedullary nail

Group Type: EXPERIMENTAL

Intramedullary nail

Intervention Type: PROCEDURE

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.

Locked plate

Locked plate

Group Type: EXPERIMENTAL

Locked plate

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

SURFIX, Integra; Multilock, SYNTHES

Eligibility Criteria

Inclusion Criteria

• patients between 40 and 85-years-old, who didn't expressed opposition to inclusion, with type III or IV displaced CEPHALOTUBEROSITY fracture( classification of Neer and DUPARC).

Exclusion Criteria

• CEPHALOTUBEROSITY fractures type IV - CT4 will not be included because it can correspond to posterior or anterior fracture-dislocation of humeral head and therefore be associated to very high risk level of avascular necrosis . In this case a surgical treatment by arthroplasty is recommended.

Dislocated fracture Patient who express opposition to inclusion polytrauma

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Boyer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard

Paris, Île-de-France Region, France

Countries

France

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

AOO269-32

Identifier Type: -

Identifier Source: org_study_id