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

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

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).

Study Overview

• Status: Completed
• Conditions: Poor Bone Quality; Treatment Complications; Proximal Humeral Fractures

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.

• Study Type: Observational
• Enrollment (Actual): 148

Contacts and Locations

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medizinische Uni Innsbruck
• China
  • Hong Kong, China
    • Queen Mary Hospital
• Germany
  • Berlin, Germany, 13353
    • Campus Virchow-Klinikum, Charité
  • Bayern
    • Muenchen, Bayern, Germany, 81675
      • Klinikum Rechts der Isar der TU München
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30169
      • Ev. Diakoniewerk Friederikenstift
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel
  • Luzern, Switzerland, 6000
    • Kantonsspital
  • Zuerich, Switzerland, 8063
    • Stadtspital Triemli
  • Waadt
    • Lausanne, Waadt, Switzerland, 1011
      • Centre Hosp Univ Vaudois
  • Zuerich
    • Winterthur, Zuerich, Switzerland, 8401
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Orthopedic and trauma clinics

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Range of motion	The bilateral range of motion will be measured by clinical examination as follows: Flexion / extension; Abduction; External / internal rotation	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	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	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.	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.	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.	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.	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.	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.	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.	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.	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).	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Franz Kralinger, MD, Medizinische Uni Innsbruck

Publications and helpful links

General Publications

• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: June 11, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (Estimate): June 14, 2010

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Postoperative complications; Osteoporosis; Bone density; Intraoperative complications; Humerus fractures; Tomography, x-ray computed; Bone and bones; Orthopedic fixation devices; Radiography, dual-energy scanned projection
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: FFOB-Hum