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Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

Primary Purpose

Proximal Humeral Fracture, Osteosynthesis or Conservative Treatment

Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Surgical treatment with LCP
Sponsored by
University Hospital, Aker
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Humeral Fracture focused on measuring Proximal Humerus Fracture in elderly

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital

Exclusion Criteria:

  • aged less than 60 year
  • patients of non-Scandinavian ethnicity
  • previous history of injury or illness of the injured or contralateral shoulder
  • injury of other part of the humerus or the contralateral upper extremity,
  • alcohol- or drug abuse
  • dementia or neurological diseases
  • severe cardiovascular disease that would contraindicate surgery

Sites / Locations

  • Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conservative /Physiotherapy

Surgery with LCP T plate

Arm Description

Active training protocol with instructed physiotherapy and self excercises

Surgical treatment with interlocking plate

Outcomes

Primary Outcome Measures

Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).

Secondary Outcome Measures

QALY (HRQoL score according to Harri Sintonen 15D and Costs)
ASES score (modified self assessment) C) Radiographic score
Radiographic score

Full Information

First Posted
March 16, 2009
Last Updated
April 22, 2015
Sponsor
University Hospital, Aker
Collaborators
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT00863473
Brief Title
Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment
Official Title
Health and Cost Consequenses of Surgical Versus Conservative Treatment for a Comminuted Humerus Fracture. Do Interlocking Plate Surgery Benefit Displaced Proximal Humerus Fractures? A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Aker
Collaborators
University of Oslo

4. Oversight

5. Study Description

Brief Summary
Do a standardized surgical treatment of unstable displaced proximal humerus fracture in patients aged over 60 compared to a standardized conservative treatment gain a better functional outcome after one year? Do surgical treatment gain more QALY than conservative treatment after one year?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture, Osteosynthesis or Conservative Treatment
Keywords
Proximal Humerus Fracture in elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative /Physiotherapy
Arm Type
No Intervention
Arm Description
Active training protocol with instructed physiotherapy and self excercises
Arm Title
Surgery with LCP T plate
Arm Type
Active Comparator
Arm Description
Surgical treatment with interlocking plate
Intervention Type
Procedure
Intervention Name(s)
Surgical treatment with LCP
Primary Outcome Measure Information:
Title
Functional shoulder score according to Constant (Original described Differences between the injured and uninjured shoulder as well as Adjusted according to age and gender).
Time Frame
12 and 24 months
Secondary Outcome Measure Information:
Title
QALY (HRQoL score according to Harri Sintonen 15D and Costs)
Time Frame
12 and 24 months
Title
ASES score (modified self assessment) C) Radiographic score
Time Frame
12 and 24 months
Title
Radiographic score
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: proximal humerus fracture of AO group B2 or C2 (displaced fracture of extra-articular or articular, bifocal type) admitted in hospital Exclusion Criteria: aged less than 60 year patients of non-Scandinavian ethnicity previous history of injury or illness of the injured or contralateral shoulder injury of other part of the humerus or the contralateral upper extremity, alcohol- or drug abuse dementia or neurological diseases severe cardiovascular disease that would contraindicate surgery
Facility Information:
Facility Name
Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0514
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21804410
Citation
Fjalestad T, Hole MO, Hovden IA, Blucher J, Stromsoe K. Surgical treatment with an angular stable plate for complex displaced proximal humeral fractures in elderly patients: a randomized controlled trial. J Orthop Trauma. 2012 Feb;26(2):98-106. doi: 10.1097/BOT.0b013e31821c2e15.
Results Reference
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PubMed Identifier
19945102
Citation
Fjalestad T, Hole MO, Jorgensen JJ, Stromsoe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury. 2010 Jun;41(6):599-605. doi: 10.1016/j.injury.2009.10.056. Epub 2009 Nov 27.
Results Reference
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PubMed Identifier
24413845
Citation
Fjalestad T, Hole MO. Displaced proximal humeral fractures: operative versus non-operative treatment--a 2-year extension of a randomized controlled trial. Eur J Orthop Surg Traumatol. 2014 Oct;24(7):1067-73. doi: 10.1007/s00590-013-1403-y. Epub 2014 Jan 11.
Results Reference
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Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment

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