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

Not Applicable

Completed

• Conditions: Proximal Humerus Fractures
• Interventions: Procedure: Intramedullary nail; Procedure: Locked plate

• Registration Number: NCT01557413
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-16
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramedullary nail	Intramedullary nail	Intramedullary nail
Locked plate	Locked plate	Locked plate

Primary Outcome Measures

Name	Time	Method
Constant and MURLEY Score	12 months	comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)

Secondary Outcome Measures

Name	Time	Method
Quick Dash, complication (mal union, necrosis, infection)	6 and 18 months	comparison of Constant-Murley score after 6 and 18 months, comparison of complications rates and patients satisfaction( DASH and STT scores).; Those criteriae will be analysed on global groups and for each Neer and Duparc classification type fracture.

Trial Locations

Locations (1)

Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard; 🇫🇷 Paris, Ile de France, France