Clinical trial NCT01143675: Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
Official title: The Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fractures
Poor Bone Quality
Treatment Complications
Keywords: Humerus fractures
Tomography, x-ray computed
Bone and bones
Orthopedic fixation devices
Surgery
Postoperative complications
Osteoporosis
Intraoperative complications
Bone density
Radiography, dual-energy scanned projection
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 148
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopedic and trauma clinics

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Local bone quality-related complication
timeFrame: From enrollment to 12 months postoperative
Secondary outcomes:
measure: Bone mineral density at the distal radius by DXA
timeFrame: until 6 week postoperative
measure: Occurence of any complication
timeFrame: 6 weeks
measure: Occurence of any complication
timeFrame: 3 months
measure: Occurence of any complication
timeFrame: 12 months
measure: Range of motion
timeFrame: 6 weeks
measure: Range of motion
timeFrame: 3 months
measure: Range of motion
timeFrame: at 12 month follow-up
measure: Constant-Murley Score
timeFrame: 3 months
measure: Constant-Murley Score
timeFrame: 6 weeks
measure: Constant-Murley Score
timeFrame: 12 months
measure: Patient self-assessment of shoulder function - SPADI
timeFrame: Baseline
measure: Patient self-assessment of shoulder function - SPADI
timeFrame: 6 weeks
measure: Patient self-assessment of shoulder function - SPADI
timeFrame: 3 months
measure: Patient self-assessment of shoulder function with the SPADI
timeFrame: 6 months
measure: Patient self-assessment of shoulder function with the SPADI
timeFrame: 12 months
measure: Disability of the shoulder and hand - DASH
timeFrame: Baseline
measure: Patient self-assessment of upper extremity function with the DASH
timeFrame: 6 weeks
measure: Patient self-assessment of upper extremity function with the DASH
timeFrame: 3 months
measure: Patient self-assessment of upper extremity function with the DASH
timeFrame: 12 months
measure: Health-related quality of life - EuroQoL5
timeFrame: Baseline
measure: EuroQoL5
timeFrame: 6 weeks
measure: EuroQoL5
timeFrame: 3 months
measure: EuroQoL5
timeFrame: 6 months
measure: EuroQoL5
timeFrame: 12 months
measure: Validation of a Computed Tomography (CT)-based method for BMD-measurement at the proximal humerus
timeFrame: preoperative
measure: Association between the BMD at the proximal humerus (measured by CT) and the BMD at the distal radius (measured by DXA)
timeFrame: until 6 weeks postoperative
measure: Occurence of any complication
timeFrame: Baseline
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Uni Innsbruck
state: Tirol
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TU München
state: Bayern
city: Hannover
country: Germany
facility: Ev. Diakoniewerk Friederikenstift
state: Niedersachsen
city: Berlin
country: Germany
facility: Campus Virchow-Klinikum, Charité
city: Lausanne
country: Switzerland
facility: Centre Hosp Univ Vaudois
state: Waadt
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zuerich
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Luzern
country: Switzerland
facility: Kantonsspital
city: Zuerich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Medizinische Uni Innsbruck
name: Franz Kralinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldhahn S, Kralinger F, Rikli D, Marent M, Goldhahn J. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies. BMC Musculoskelet Disord. 2010 Nov 9;11:256. doi: 10.1186/1471-2474-11-256.