Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures (HUMERUS)
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| First Received Date ICMJE | March 16, 2012 | ||||
| Last Updated Date | March 16, 2012 | ||||
| Start Date ICMJE | February 2012 | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Constant and MURLEY Score [ Time Frame: 12 months ] [ Designated as safety issue: No ] comparaison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Quick Dash, complication (mal union, necrosis, infection) [ Time Frame: 3, 6 and 18 months ] [ Designated as safety issue: No ] comparaision of Constant-Murley score after 3, 6 and 18 months, comparision 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures | ||||
| Official Title ICMJE | Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Proximal Humerus Fractures | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 144 | ||||
| Estimated Completion Date | November 2015 | ||||
| Estimated Primary Completion Date | August 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Dislocated fracture Patient who express opposition to inclusion polytrauma |
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| Gender | Both | ||||
| Ages | 40 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01557413 | ||||
| Other Study ID Numbers ICMJE | AOO269-32 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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