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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01557413
First received: March 16, 2012
Last updated: August 28, 2014
Last verified: August 2014

March 16, 2012
August 28, 2014
February 2012
February 2017   (final data collection date for primary outcome measure)
Constant and MURLEY Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
comparison of shoulder function outcome between 2 groups using Constant- Murley score after 12 months( mobility, function, pain and strength)
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)
Complete list of historical versions of study NCT01557413 on ClinicalTrials.gov Archive Site
Quick Dash, complication (mal union, necrosis, infection) [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]

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.

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.

Not Provided
Not Provided
 
Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures
Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Proximal Humerus Fractures
  • 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
  • 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
  • Experimental: Intramedullary nail
    Intramedullary nail
    Intervention: Procedure: Intramedullary nail
  • Experimental: Locked plate
    Locked plate
    Intervention: Procedure: Locked plate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
August 2017
February 2017   (final data collection date for primary outcome measure)

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

Both
40 Years to 85 Years
No
Contact: Patrick Boyer, MD, PhD 01.40.25.75.00 ext + 33 patrick.boyer@bch.aphp.fr
France
 
NCT01557413
AOO269-32
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Patrick Boyer, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP