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Completed

NCT Number: NCT01143675

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).

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Key information

Conditions

Proximal Humeral Fractures Arm Injuries Bone Diseases Bone Diseases, Metabolic Fractures, Bone Humeral Fractures Intraoperative Complications Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Pathologic Processes Pathological Conditions, Signs and Symptoms Poor Bone Quality Postoperative Complications Shoulder Fractures Shoulder Injuries Treatment Complications Wounds and Injuries

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Uni Innsbruck, Innsbruck, Tyrol, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Local bone quality-related complication

    Time frame: From enrollment to 12 months postoperative

    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.

Secondary outcomes

  1. Bone mineral density at the distal radius by DXA

    Time frame: until 6 week postoperative

    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.

  2. Occurence of any complication

    Time frame: 6 weeks

    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. Occurence of any complication

    Time frame: 3 months

    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.

  4. Occurence of any complication

    Time frame: 12 months

    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.

  5. Range of motion

    Time frame: 6 weeks

    The bilateral range of motion will be measured by clinical examination as follows:

    • Flexion / extension
    • Abduction
    • External / internal rotation

  6. Range of motion

    Time frame: 3 months

    The bilateral range of motion will be measured by clinical examination as follows (110):

    • Flexion / extension
    • Abduction
    • External / internal rotation

  7. Range of motion

    Time frame: at 12 month follow-up

    The bilateral range of motion will be measured by clinical examination as follows (110):

    • Flexion / extension
    • Abduction
    • External / internal rotation

  8. Constant-Murley Score

    Time frame: 3 months

    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.

  9. Constant-Murley Score

    Time frame: 6 weeks

    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.

  10. Constant-Murley Score

    Time frame: 12 months

    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.

  11. Patient self-assessment of shoulder function - SPADI

    Time frame: Baseline

    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. Patient self-assessment of shoulder function - SPADI

    Time frame: 6 weeks

    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.

  13. Patient self-assessment of shoulder function - SPADI

    Time frame: 3 months

    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.

  14. Patient self-assessment of shoulder function with the SPADI

    Time frame: 6 months

    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.

  15. Patient self-assessment of shoulder function with the SPADI

    Time frame: 12 months

    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.

  16. Disability of the shoulder and hand - DASH

    Time frame: Baseline

    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).

  17. Patient self-assessment of upper extremity function with the DASH

    Time frame: 6 weeks

    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).

  18. Patient self-assessment of upper extremity function with the DASH

    Time frame: 3 months

    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).

  19. Patient self-assessment of upper extremity function with the DASH

    Time frame: 12 months

    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).

  20. Health-related quality of life - EuroQoL5

    Time frame: Baseline

    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.

  21. EuroQoL5

    Time frame: 6 weeks

    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.

  22. EuroQoL5

    Time frame: 3 months

    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.

  23. EuroQoL5

    Time frame: 6 months

    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.

  24. EuroQoL5

    Time frame: 12 months

    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.

  25. Validation of a Computed Tomography (CT)-based method for BMD-measurement at the proximal humerus

    Time frame: preoperative

    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.

  26. Association between the BMD at the proximal humerus (measured by CT) and the BMD at the distal radius (measured by DXA)

    Time frame: until 6 weeks postoperative

    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.

  27. Occurence of any complication

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

AO Clinical Investigation and Publishing Documentation

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 14, 2010
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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