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

April 22, 2015 updated by: Tore Fjalestad, University Hospital, Aker

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

  1. 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?
  2. Do surgical treatment gain more QALY than conservative treatment after one year?

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, N-0514
        • Tore Fjalestad, Ortopeadic Dept, Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative /Physiotherapy
Active training protocol with instructed physiotherapy and self excercises
Active Comparator: Surgery with LCP T plate
Surgical treatment with interlocking plate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
QALY (HRQoL score according to Harri Sintonen 15D and Costs)
Time Frame: 12 and 24 months
12 and 24 months
ASES score (modified self assessment) C) Radiographic score
Time Frame: 12 and 24 months
12 and 24 months
Radiographic score
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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