Proximal Humeral FracturesNCT01143675
Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
An observational study of Proximal Humeral Fractures and Poor Bone Quality, run by AO Clinical Investigation and Publishing Documentation at 10 sites in 4 countries.
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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Proximal Humeral Fractures, Poor Bone Quality, Treatment Complications
- How many people
- 148 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Mar 2007to Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic and trauma clinics
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Switzerland5 sites
Universitätsspital Basel
Basel, 4031
Centre Hosp Univ Vaudois
Lausanne, Canton of Vaud, 1011
Kantonsspital
Lucerne, 6000
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8401
Stadtspital Triemli
Zurich, 8063
Germany3 sites
Campus Virchow-Klinikum, Charité
Berlin, 13353
Ev. Diakoniewerk Friederikenstift
Hanover, Lower Saxony, 30169
Klinikum rechts der Isar der TU München
Munich, Bavaria, 81675
About this study
Official title: 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).
Read the 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.
- 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
- Medical subject headings
- Shoulder Fractures, Humeral Fractures, Postoperative Complications, Osteoporosis, Intraoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 months postoperative
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Range of motion
The bilateral range of motion will be measured by clinical examination as follows:
- Flexion / extension
- Abduction
- External / internal rotation
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMar 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Humeral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franz Kralinger, MD, Principal investigator, Medizinische Uni Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143675
- Sponsor's protocol ID
- FFOB-Hum
- Status last verified
- Aug 2020
- First submitted
- 11 Jun 2010
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21062463
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
- ClinicalTrials.gov ID
- NCT01143675
- Acronym / sponsor ID
- FFOB-Hum
- Keywords
- Humerus fractures, Tomography, x-ray computed, Bone and bones, Orthopedic fixation devices, Surgery, Postoperative complications, Osteoporosis, Intraoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic and trauma clinics
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
27 secondary outcomes
Bone mineral density at the distal radius by DXA
Time frame: until 6 week postoperative
Occurence of any complication
Time frame: 6 weeks
Occurence of any complication
Time frame: 3 months
Occurence of any complication
Time frame: 12 months
Range of motion
Time frame: 6 weeks
Range of motion
Time frame: 3 months
Range of motion
Time frame: at 12 month follow-up
Constant-Murley Score
Time frame: 3 months
Constant-Murley Score
Time frame: 6 weeks
Constant-Murley Score
Time frame: 12 months
Patient self-assessment of shoulder function - SPADI
Time frame: Baseline
Patient self-assessment of shoulder function - SPADI
Time frame: 6 weeks
Patient self-assessment of shoulder function - SPADI
Time frame: 3 months
Patient self-assessment of shoulder function with the SPADI
Time frame: 6 months
Patient self-assessment of shoulder function with the SPADI
Time frame: 12 months
Disability of the shoulder and hand - DASH
Time frame: Baseline
Patient self-assessment of upper extremity function with the DASH
Time frame: 6 weeks
Patient self-assessment of upper extremity function with the DASH
Time frame: 3 months
Patient self-assessment of upper extremity function with the DASH
Time frame: 12 months
Health-related quality of life - EuroQoL5
Time frame: Baseline
EuroQoL5
Time frame: 6 weeks
EuroQoL5
Time frame: 3 months
EuroQoL5
Time frame: 6 months
EuroQoL5
Time frame: 12 months
Validation of a Computed Tomography (CT)-based method for BMD-measurement at the proximal humerus
Time frame: preoperative
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
Occurence of any complication
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 21062463Goldhahn 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.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franz Kralinger, MD principal investigator
Medizinische Uni Innsbruck
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proximal Humeral Fractures and Poor Bone Quality, run by AO Clinical Investigation and Publishing Documentation at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, Germany, Austria, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local bone quality-related complication (time frame: From enrollment to 12 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.