Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures
HUMERUS
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFebruary 23, 2017
February 1, 2017
4.8 years
March 16, 2012
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Constant and MURLEY Score
comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)
12 months
Secondary Outcomes (1)
Quick Dash, complication (mal union, necrosis, infection)
6 and 18 months
Study Arms (2)
Intramedullary nail
EXPERIMENTALIntramedullary nail
Locked plate
EXPERIMENTALLocked plate
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard
Paris, Île-de-France Region, 75018, France
Related Publications (1)
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
PMID: 35727196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Boyer, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2012
First Posted
March 19, 2012
Study Start
February 1, 2012
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
February 23, 2017
Record last verified: 2017-02