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

Proximal Humeral Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143675
• Other study ID #: FFOB-Hum
• Status: Completed
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: August 2020
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Poor Bone Quality
• Proximal Humeral Fractures
• Shoulder Fractures
• Treatment Complications

Locations

Country	Name	City	State
Austria	Medizinische Uni Innsbruck	Innsbruck	Tirol
China	Queen Mary Hospital	Hong Kong
Germany	Campus Virchow-Klinikum, Charité	Berlin
Germany	Ev. Diakoniewerk Friederikenstift	Hannover	Niedersachsen
Germany	Klinikum rechts der Isar der TU München	Muenchen	Bayern
Switzerland	Universitätsspital Basel	Basel
Switzerland	Centre Hosp Univ Vaudois	Lausanne	Waadt
Switzerland	Kantonsspital	Luzern
Switzerland	Kantonsspital Winterthur	Winterthur	Zuerich
Switzerland	Stadtspital Triemli	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Countries where clinical trial is conducted

Austria,  China,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From enrollment to 12 months postoperative
Secondary	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.	until 6 week postoperative
Secondary	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.	6 weeks
Secondary	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.	3 months
Secondary	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.	12 months
Secondary	Range of motion	The bilateral range of motion will be measured by clinical examination as follows: Flexion / extension; Abduction; External / internal rotation	6 weeks
Secondary	Range of motion	The bilateral range of motion will be measured by clinical examination as follows (110): Flexion / extension; Abduction; External / internal rotation	3 months
Secondary	Range of motion	The bilateral range of motion will be measured by clinical examination as follows (110): Flexion / extension; Abduction; External / internal rotation	at 12 month follow-up
Secondary	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.	3 months
Secondary	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.	6 weeks
Secondary	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.	12 months
Secondary	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.	Baseline
Secondary	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.	6 weeks
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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).	Baseline
Secondary	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).	6 weeks
Secondary	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).	3 months
Secondary	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).	12 months
Secondary	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.	Baseline
Secondary	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.	6 weeks
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	preoperative
Secondary	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.	until 6 weeks postoperative
Secondary	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.	Baseline

External Links

•   Non profit organization dedicated to improving the care of patients with musculoskeletal injuries and their sequelae through research, development, education and quality assurance in the principles, practice, and result of fracture treatment.