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Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures

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ClinicalTrials.gov Identifier: NCT02944058
Recruitment Status : Recruiting
First Posted : October 25, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Asbjorn Aroen, University Hospital, Akershus

Brief Summary:
The purpose of the project is to compare the management of 3 and 4 part proximal humerus fractures (PHF) with an angular stable plate (Philos) with that of an intramedullary nail (Multiloc) in light of complications, radiological, economical, functional and clinical outcome.

Condition or disease Intervention/treatment Phase
Shoulder Fractures Humeral Fractures, Proximal Procedure: Multiloc nail Procedure: Philos plate Not Applicable

Detailed Description:
Randomized controlled trial (RCT) from Akershus University Hospital in Norway. Randomization between two implants. The investigators will use deltopectoral or deltoid split as surgical access. All patients will have calcar screws and cuff sutures. When lack of bone for example after decompressing valgus compressed fractures, a bone-substitute might be used in the surgeons preference. Follow up in outpatient clinic at 6, 12, 52 and 104 weeks, but also a 5 year follow up is planned. Postoperative radiographs of both shoulders and CT of operated shoulder will be taken.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Plate Fixation Versus Intramedullary Nailing of 3 and 4 Part Proximal Humerus Fractures. A RCT
Study Start Date : October 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Philos plate
Intervention is surgery with Philos plate
Procedure: Philos plate
Intervention is surgery with Philos plate

Active Comparator: Multiloc nail
Intervention is surgery with Multiloc nail
Procedure: Multiloc nail
Intervention is surgery with Multiloc nail




Primary Outcome Measures :
  1. The Disabilities of the Arm, Shoulder and Hand (DASH) Score (questionnaire) Disability of the arm, shoulder and arm score (DASH score) [ Time Frame: 5 years ]
    Quick Dash (questionnaire) the first 6 weeks after surgery, then DASH score (questionnaire for patients to fill out) in follow ups


Secondary Outcome Measures :
  1. Constant score (questionnaire) [ Time Frame: 5years ]
    A questionnaire for the doctor or the physiotherapist to fill out, including registration of: Pain, Power, Range of motion and ADL (x/100, where 100 is best score)

  2. Radiological complications [ Time Frame: 5 years ]
    Plate cutout, Nail migration, screw cutout, Reduction of Head shaft angle (HSA)/ Varus subsidence,

  3. Complications [ Time Frame: 5 years ]
    Infection, Avascular necrosis, thrombosis, nerve compression or damage, Pseudoarthrosis

  4. Health economy [ Time Frame: 5 years ]
    Registration of visits to doctor, physiotherapist, sick leave, re-operations



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients > 18 years
  2. Severe displacement, defined as malposition of at least 45⁰ of angular deviation in valgus or 30⁰ in varus in true frontal projection, regardless of whether the fracture is impacted or not. Fractures with more than 50% displacement of the head against the surgical neck
  3. The greater or lesser tubercles must be fractured in a 3 or 4-part fracture. The degree of displacement is not critical for inclusion.

Exclusion Criteria:

Exclusion criteria:

  1. Fracture more than 3 weeks' old
  2. Caput humeri just a thin shell or split
  3. Ipsilateral damage that will influence the recovery and scoring systems
  4. Incapability to protect osteosynthesis, i.e. use of crutches because of injury to lower extremity.
  5. Pathological fracture
  6. Neurovascular injury
  7. Open fracture
  8. Noncompliance
  9. Congenital anomaly
  10. Ongoing infectious process around the incision site for plate osteosynthesis
  11. Systemic disease that may influence healing processes or scoring systems (RA/MS)
  12. Fracture dislocation
  13. Substance abuse
  14. Inability to read and understand Norwegian
  15. Patients not residing in our catchment area
  16. Patients with too small humerus diameter to use a nail
  17. Patient not able to commit and understand written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944058


Contacts
Contact: Annette KB Wikerøy, MD 004799717481 awikeroy@hotmail.com
Contact: Per Henrik Randsborg, PhD, MD 0047 97040480 phrandsborg@yahoo.no

Locations
Norway
Akershus University hospital Recruiting
Lørenskog, Norway, 1478
Contact: Asbjorn Aaroen, Professor         
Sponsors and Collaborators
University Hospital, Akershus
Investigators
Study Director: Asbjorn AAroen, PhD MD Akershus University Hospital, orthopedic unit

Responsible Party: Asbjorn Aroen, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02944058     History of Changes
Other Study ID Numbers: 2016/626
First Posted: October 25, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion

Keywords provided by Asbjorn Aroen, University Hospital, Akershus:
Multiloc
Philos
Locking plate
Straight nail
Randomized controlled trial
3 and 4 part fractures

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