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

This study is currently recruiting participants.
Verified August 2013 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 26, 2013
Last verified: August 2013
  Purpose

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 Intervention
Proximal Humerus Fractures
Procedure: Intramedullary nail
Procedure: Locked plate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Study Between Intramedullary Locking Nails and Locking Plates for Treatment of Proximal Humerus Fractures in Patients After 40-year-old

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 84
Study Start Date: February 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intramedullary nail
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
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557413

Contacts
Contact: Patrick Boyer, MD, PhD 01.40.25.75.00 ext + 33 patrick.boyer@bch.aphp.fr

Locations
France
Groupe Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard Recruiting
Paris, Ile de France, France, 75018
Contact: Patrick Boyer, MD, PhD    01.40.25.75.00 ext + 33    patrick.boyer@bch.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Patrick Boyer, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01557413     History of Changes
Other Study ID Numbers: AOO269-32
Study First Received: March 16, 2012
Last Updated: August 26, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Humerus
fracture
nail
plate
tuberosity

Additional relevant MeSH terms:
Fractures, Bone
Humeral Fractures
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on April 16, 2014