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Completed

NCT Number: NCT01557413

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

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.

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Key information

Conditions

Proximal Humerus Fractures Fractures, Bone Wounds and Injuries

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, Île-de-France Region, 75018, France

About this study

: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intramedullary nail

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.

Other names: SURFIX, Integra

Locked plate

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.

Other names: Multilock, SYNTHES

Primary outcomes

  1. Constant and MURLEY Score

    Time frame: 12 months

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

Secondary outcomes

  1. Quick Dash, complication (mal union, necrosis, infection)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: HUMERUS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2012
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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