Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures (HUMERUS)
|ClinicalTrials.gov Identifier: NCT01557413|
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : February 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Proximal Humerus Fractures||Procedure: Intramedullary nail Procedure: Locked plate||Not Applicable|
: 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Intramedullary nail
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.
Other Name: SURFIX, Integra
Experimental: Locked plate
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.
Other Name: Multilock, SYNTHES
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557413
|Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard|
|Paris, Ile de France, France, 75018|
|Principal Investigator:||Patrick Boyer, MD, PhD||Assistance Publique - Hôpitaux de Paris|