An interventional study of Intramedullary nail and Locked plate in Proximal Humerus Fractures, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
: 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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 80 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dislocated fracture Patient who express opposition to inclusion polytrauma
Intramedullary nail
Procedure: Intramedullary nail
Locked plate
Procedure: Locked plate
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.
Also known as: SURFIX, Integra
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.
Also known as: Multilock, SYNTHES
Constant and MURLEY Score
comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)
Time frame: 12 months
Quick Dash, complication (mal union, necrosis, infection)
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.
Time frame: 6 and 18 months
Plan to share: Undecided
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris