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).
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.
Study Type
OBSERVATIONAL
Enrollment
148
Medizinische Uni Innsbruck
Innsbruck, Tyrol, Austria
Queen Mary Hospital
Hong Kong, China
Klinikum rechts der Isar der TU München
Munich, Bavaria, Germany
Ev. Diakoniewerk Friederikenstift
Local bone quality-related complication
The qualifying events are those involving either directly the local bone and fracture or the implant and its surgical application whether they are anticipated or not.
Time frame: From enrollment to 12 months postoperative
Bone mineral density at the distal radius by DXA
The BMD at the distal radius will be measured by DXA. It will comprise BMD and BMC of the contralateral side. The absolute values for BMD and BMC will be provided as well as the deviations to the T-score according to the manufacturer's reference collective.
Time frame: until 6 week postoperative
Occurence of any complication
To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.
Time frame: 6 weeks
Occurence of any complication
To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.
Time frame: 3 months
Occurence of any complication
To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation.
Time frame: 12 months
Range of motion
The bilateral range of motion will be measured by clinical examination as follows: * Flexion / extension * Abduction * External / internal rotation
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Hanover, Lower Saxony, Germany
Campus Virchow-Klinikum, Charité
Berlin, Germany
Centre Hosp Univ Vaudois
Lausanne, Canton of Vaud, Switzerland
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
Universitätsspital Basel
Basel, Switzerland
Kantonsspital
Lucerne, Switzerland
Stadtspital Triemli
Zurich, Switzerland
Time frame: 6 weeks
Range of motion
The bilateral range of motion will be measured by clinical examination as follows (110): * Flexion / extension * Abduction * External / internal rotation
Time frame: 3 months
Range of motion
The bilateral range of motion will be measured by clinical examination as follows (110): * Flexion / extension * Abduction * External / internal rotation
Time frame: at 12 month follow-up
Constant-Murley Score
Functional assessment of shoulder . The range of total scores is 1 to 100 and is composed of a subjective (mainly pain) and an objective parameters.
Time frame: 3 months
Constant-Murley Score
Functional assessment of shoulder . The range of total scores is 1 to 100 and is composed of a subjective (mainly pain) and an objective parameters.
Time frame: 6 weeks
Constant-Murley Score
Functional assessment of shoulder . The range of total scores is 1 to 100 and is composed of a subjective (mainly pain) and an objective parameters.
Time frame: 12 months
Patient self-assessment of shoulder function - SPADI
SPADI assesses the pain and disability associated with shoulder pathology. It is a self-reported index consisting of 13 items divided into two subscales: pain and disability. The range of total scores is 1 to 100.
Time frame: Baseline
Patient self-assessment of shoulder function - SPADI
SPADI assesses the pain and disability associated with shoulder pathology. It is a self-reported index consisting of 13 items divided into two subscales: pain and disability. The range of total scores is 1 to 100.
Time frame: 6 weeks
Patient self-assessment of shoulder function - SPADI
SPADI assesses the pain and disability associated with shoulder pathology. It is a self-reported index consisting of 13 items divided into two subscales: pain and disability. The range of total scores is 1 to 100.
Time frame: 3 months
Patient self-assessment of shoulder function with the SPADI
SPADI assesses the pain and disability associated with shoulder pathology. It is a self-reported index consisting of 13 items divided into two subscales: pain and disability. The range of total scores is 1 to 100.
Time frame: 6 months
Patient self-assessment of shoulder function with the SPADI
SPADI assesses the pain and disability associated with shoulder pathology. It is a self-reported index consisting of 13 items divided into two subscales: pain and disability. The range of total scores is 1 to 100.
Time frame: 12 months
Disability of the shoulder and hand - DASH
The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).
Time frame: Baseline
Patient self-assessment of upper extremity function with the DASH
The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).
Time frame: 6 weeks
Patient self-assessment of upper extremity function with the DASH
The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).
Time frame: 3 months
Patient self-assessment of upper extremity function with the DASH
The disability of the arm, shoulder and hand (DASH) questionnaire is an upper extremity specific outcome measure. The main part of the DASH is a 30-item disability/symptom scale concerning the patient's health status during the preceding week. The scores for all items are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability).
Time frame: 12 months
Health-related quality of life - EuroQoL5
EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.
Time frame: Baseline
EuroQoL5
EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.
Time frame: 6 weeks
EuroQoL5
EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.
Time frame: 3 months
EuroQoL5
EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.
Time frame: 6 months
EuroQoL5
EQ-5D is a standardised instrument for use as a measure of health outcome.It has five items with a three-point categorical response scale (no problems, some/moderate problems, extreme problems. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions.
Time frame: 12 months
Validation of a Computed Tomography (CT)-based method for BMD-measurement at the proximal humerus
The BMD (mg/cm3) at the proximal humerus will be determined preoperatively for the contralateral side of the fracture with a general purpose CT scanner, according to the protocol. Briefly, a CT of the contralateral humerus is performed measuring simultaneously the European Forearm Phantom (EFP) applied on the patient's midthorax. The measured CT Hounsfield Units (HU) of user-defined ROIs can then be quantified with the EFPbased calibration curve, resulting in BMD-values.
Time frame: preoperative
Association between the BMD at the proximal humerus (measured by CT) and the BMD at the distal radius (measured by DXA)
Bone density measurements at the left and right proximal and distal humerus have been correlated by Diederichs and colleagues. BMD comparison between left and right humeri revealed higher correlations for the distal (R2 = 0.9) and the proximal humerus (R2 = 0.74) than comparison between proximal and distal humerus (R2 = 0.4) (97). These date suggest that the contralateral should be favored to the ipsilateral location when estimating the bone density of a fractured site.
Time frame: until 6 weeks postoperative
Occurence of any complication
To capture any complication that occured. A complication is defined as any occurrence or deviation from the normal treatment or outcome, regardless of whether it has any relationship with the treatment or product under investigation. The reported complication will be classified by AOCID as either serious or non-serious AE or as an anticipated complication.
Time frame: Baseline