Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).

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Detailed Description

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More than 70% of patients with a proximal humerus fracture are older than 60 years, up to three quarters are women and the incidence of low-energy fractures increases exponentially with age. The standard diagnostic method for classifying osteoporosis is the measurement of Bone Mineral Density at specific body sites - hip, vertebra or distal radius. Despite the fact that osteoporotic fractures are very frequent at the shoulder, no study investigated the correlation between local bone quality and fracture treatment at the proximal humerus.

There is a concern among the clinicians that osteoporotic bone in proximal humerus fractures increases the risk of treatment complications. However, to our knowledge this has not yet been evaluated in clinical studies. One major reason for this lack of studies is the fact that no standardized method exists for the determination of bone density at the proximal humerus.

Conditions

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Proximal Humeral Fractures Poor Bone Quality Treatment Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Radiologically confirmed closed fracture (within 10 days) of the proximal humerus
* All dislocated (mod. Neer) proximal humerus fractures except dislocated fractures of the greater and lesser tuberosity
* Primary fracture treatment with a PHILOS-plate
* Age equal greater than 50 and equal younger than 90 years
* Normal function of both shoulders (pre-trauma) according to age
* Monotrauma
* Willing and able to give written informed consent to participate in the study
* Willing and able to participate in the study follow-ups according to the CIP
* Willing and able to comply with the postoperative management program
* Able to understand and read country national language

Exclusion Criteria

* Open proximal humerus fractures
* Concomitant contralateral proximal humerus fracture
* Previous proximal humerus fracture on either side after the age of 25
* Time to operation \> 10 days
* Polytrauma
* Cuff-arthropathy of the contralateral proximal humerus
* Associated nerve or vessel injury
* Regular systemic therapy with corticosteroids due to chronic disease
* Legal incompetence
* Patient received radio- or chemotherapy prior to, during or within the last year
* Currently active cancer
* Recent history of substance abuse (i.e. recreational drugs, alcohol)
* Prisoner
* Currently involved in a pharmaceutical clinical study§
* Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
* Simultaneous participation in another orthopedic/surgical study with the same or another fracture has to be approved by the AOCID.

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No