Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05722808
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-10
First Post:
2023-02-01
Brief Title:
What is the Rate of Surgical Treatment in Adult Patients With Displaced Distal Radius Fractures Managed According to the Danish National Clinical Practice Guidelines - A Single Center Retrospective Cohort Study
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
What is the Rate of Surgical Treatment in Adult Patients With Displaced Distal Radius Fractures Managed According to the Danish National Clinical Practice Guidelines - A Single Center Retrospective Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Through this study we aim to investigate the rate of DRFs initially treated with successful closed reduction to an acceptable position then immobilized in a plaster cast that re-displace and end up requiring surgery
This study will clarify the incidence of DRFs where surgical intervention could potentially be avoided if the initial closed reduction lasted until sufficient bone healing was attained As DRFs are the most common fracture of the adult population treated in the Danish emergency departments the aim of this study is to examine the amount of people with DRFs that could potentially avoid surgery and thereby lowering the cost to the health care system as well as save the patient invasive surgery Furthermore we expect to classify which specific types of fractures according to Arbeitsgemeinschaft für Osteosynthesefragen Orthopaedic Trauma Association AOOTA classification system have a high or low incidence of secondary surgery after primary closed reduction
This study will clarify the incidence of DRFs where surgical intervention could potentially be avoided if the initial closed reduction lasted until sufficient bone healing was attained As DRFs are the most common fracture of the adult population treated in the Danish emergency departments the aim of this study is to examine the amount of people with DRFs that could potentially avoid surgery and thereby lowering the cost to the health care system as well as save the patient invasive surgery Furthermore we expect to classify which specific types of fractures according to Arbeitsgemeinschaft für Osteosynthesefragen Orthopaedic Trauma Association AOOTA classification system have a high or low incidence of secondary surgery after primary closed reduction
Detailed Description:
Study rational Only a limited number of orthopedic national clinical practice guidelines NCPG exist in Denmark In 2013 a NCPG regarding the treatment of distal radius fractures DRFs was introduced in Denmark 1 Without any major changes it was updated in 2017 which is the latest version Displaced distal radius fractures are very frequent in the adult population with about 20000 fractures pr year and the incidence is still increasing as the population ages 1 2 Two-thirds of DRFs in adults are displaced and require closed reduction 5 Unfortunately a large number of the reduced DRFs 32-64 re-displace during cast immobilization within the first weeks after reduction 1 According to the NCPG it is considered good clinical practice to offer surgical treatment to patients of any age if a conventional wrist X-ray examination following reduction of the fracture reveals one or more of the radiological parameters described in figure 1 Furthermore it is described as good clinical practice to be cautious about offering surgery to any patient with a low functional level regardless of their age 1
Background Each year about 20000 adult patients are treated for DRF in the Danish emergency departments across the country 1 Therefore the DRF is the most frequently treated fracture among adults in the Danish healthcare system As the population ages the number of DRF increases Furthermore the rate of surgical treatment of DRF increases independently probably due to an international change towards more interventional treatment favoring surgery above conservative treatment
The years up to 2013 a change was observed in the surgical method concerning treatment of DRF Internal fixation with a volar plate and screws increased at the expense of K-wires or external fixation This change is seen even based on sparse literature evidence 1
In the general population the distribution of DRFs is bimodal with the incidence peaks in young men - due to high energy trauma - and in postmenopausal women 2 The majority of DRFs in the second group are caused by a fall on an outstretched hand from ones upright position thus it is considered low-energy fractures There is a significant predominance of women to whom this type of fracture occurs which is connected to the fact that osteoporosis is an underlying cause 1 In a Swedish study Rundgren et al found that 78 of all DRFs occurred in women 2 while it was found in a British study that the rate of women to men was 6838 3
What does this trial add to current knowledge Through this study we aim to investigate the rate of DRFs initially treated with successful closed reduction to an acceptable position then immobilized in a plaster cast that re-displace and end up requiring surgery
This study will clarify the incidence of DRFs where surgical intervention could potentially be avoided if the initial closed reduction lasted until sufficient bone healing was attained As DRFs are the most common fracture of the adult population treated in the Danish emergency departments the aim of this study is to examine the amount of people with DRFs that could potentially avoid surgery and thereby lowering the cost to the health care system as well as save the patient invasive surgery Furthermore we expect to classify which specific types of fractures according to Arbeitsgemeinschaft für Osteosynthesefragen Orthopaedic Trauma Association AOOTA classification system have a high or low incidence of secondary surgery after primary closed reduction
Hypothesis We estimate the rate of surgical intervention of DRFs initially reduced to an acceptable position to be above 40
Aim The primary objective is to assess the rate of surgical treatment in adult patients with distal radial fractures initially reduced successfully managed in a single center according to the danish national clinical practice guidelines NCPG
Primary endpoint The purpose of this study is to determine the frequency of secondary displacement of DRFs initially treated with closed reduction and casting but subsequently resulting in secondary surgery
Secondary endpoints
We aim to compare the rate of DRF displacement following primary closed reduction found in this study with a similar cohort treated in the Netherlands 4
We will perform a sub analysis of risk of secondary displacement according to the Arbeitsgemeinschaft für Osteosynthesefragen AO classification system for DRFs
We will determine the frequency of DRFs with unacceptable position according to NCPG following initial reduction that are treated non-surgical
We will determine the number of reductions performed at the initial visit in the emergency department following a distal radius fracture per patient
Study Design This study will be conducted as a retrospective cohort study In addition outcomes from this study will be compared to outcomes from a comparable cohort from a previous retrospective study conducted in the Netherlands
Population Adult patients with displaced DRFs treated at North Zealand Hospital Nordsjællands Hospital NOH from 112018 to 31122019
Inclusion criteria Adult patients 18 years with a DRF DS252 DS252A DS252B DS252C and DS526 treated in the emergency department at NOH
Exclusion criteria
Concomitant fracture of the ulna except ulnar styloid process fractures
Non-displaced DRFs
Multiple trauma patients
Ipsilateral upper extremity fractures interfering with the treatment of the DRF Method Data will be retrieved from the electronic patient records Sundhedsplatformen SP Potential participants will be identified by relevant diagnosis codes DS252 DS252A DS252B DS252C and DS526 treated in the emergency department at NOH with closed reduction and an immobilizing cast from Jan 1st 2018 to Dec 31st 2019 We expect to include approximately 750 participants
Data relevant to the above-described outcomes ie radiologic data diagnosisprocedure codes and information from outpatient clinic visits and data relevant for baseline characteristics will be extracted from patient electronic journals and transferred to investigators
All extracted data will be transferred in pseudonymized form to an on-line data capturing system REDCAP
A team of orthopedic surgeons from the orthopedic department NOH will be asked to assess radiographic images from the initial visit to the emergency department to assess
Classification according to AO
Non-displaced yesno
Radiographic measurements according to httpswwwncbinlmnihgovpmcarticlesPMC4641087 radial shortening ulnar variance and volardorsal angulation
A comparable cohort from an ongoing prospective study of DRFs performed in the Netherlands has been identified and the responsible researcher has been contacted and agreed to provide data for a comparison of data between the two groups Data will be transferred in anonymized form to the primary investigator of this study and stored at a secure drive The primary and secondary outcomes outlined above will be compared across the two cohorts
Due to the study design it will be possible to repeat the study in other hospitals and compare the results across the Danish emergency departments as well as international
Statistical analysis Rate of DRF displacement following initial reduction and cast treatment is described with summary statistics
Categorical and ordinal variables will be presented in percentages of the analyzed group Continuous variables will be presented as mean followed by standard deviation If continuous variables were not normally distributed they will be presented as median with 25 and 75 quartiles and log transformed before further analysis
Categorical and ordinal variables are compared across groups using χ2 test Pearson test If a low number of expected frequencies is encountered Fishers exact test is used For analysis of differences in continuous variables between groups t-test will be carried out
Multiple regression will be performed to identify possible associations between relevant clinical variants and risk of DRF displacement following initial reduction and cast treatment
All statistical analyses will be performed in the SAS Studio 37 SAS Institute Inc Cary NC USA
Statistical significance is defined as a probability p-value lower than 5 Perspective The results of this study will allow us to clarify the number of patients with DRF where surgery could potentially be avoided If a specific group of patients determined radiologically due to AO-classifications with larger risk of DRF displacement following initial reduction and cast treatment is identified there would be a great incentive to improve the treatment of this group In addition the comparison with a cohorte from the Netherlands will allow us to identify international differences in treatment and diagnosis of DRFs The results of this study may eventually lead to a reduction in surgical treatment of DRFs and thereby a possible reduction in cost in relation to DRF treatment to the society
Quality control and monitoring The study will be conducted in accordance with the Helsinki declaration on Ethical Principles for Medical Research Involving Human Subjects The principles of Good Clinical Practice were followed throughout the study
The STROBE guidelines will be followed in the initiation data handling and presentation of the study
The study protocol will be registered in the The ISRCTN registry before initiation
No monitoring of the study is needed or planned of this retrospective cohort study As the radiographic data for each patient has been evaluated by orthopedic consultant or senior registrar at least three times initially in emergency department day after at conference in out-patient clinic andor in the operating theater we deem it highly unlikely that any new findings of clinical relevance should happen In the unlikely event that a new clinical finding should be done we will consult the local radiograph responsible for orthopedic radiology at NOH
Ethical considerations and data safety To protect the patients privacy and integrity data will be extrapolated from SP and pseudonymized and it will not be possible to identify the individuals This study will not have any effect on the treatment or outcome for the patient cohort but will solely help to identify improvements of future treatments This study will investigate potential areas of DRF treatment where improvement can be made to potentially avoid surgery in this large fragile population
Ethical committee approval Before the study is initiated approval from relevant ethical and data security agencies will be attained National Videnskabsetisk Komite Sundhedsdatastyrelsen Forskerservice and the Danish Data Protection Agency httpssundhedsdatastyrelsendkdaforskerserviceansog-om-data
Recruitment As this is a retrospective cohort study there is no need to recruit patients as the data needed can be found in the electronic patient records
Economy There is no funding for this project as well as no sponsors or donors The primary investigator and all secondary investigators are unpaid and perform the investigation in their spare-time Except the clinically responsible investigator Jonas Askø Andersen who is head of research in the Orthopedic department in North Zealand Hospital
Dissemination of results We expect to complete the data- and statistical analysis in September 2022 At this point the data and conclusion will be published in an international or national peer-reviewed medical journal Both positive negative and inconclusive data will be published In addition data from the study will be presented at national and international conferences if possible Should publication in a peer-reviewed journal not be possible data will be published in an open access database
Patient information As this study does not add new treatments or diagnostic methods to the patients involved and does not use individual or patient identifiable data we have applied for data access without written consent from included individuals and therefore patient information has been deemed unnecessary
References
1 httpswwwsstdk-mediaUdgivelser2014NKR-HC3A5ndledsnC3A6re-underarmsbrudNational-clinical-guideline-on-the-treatment-of-distal-radial-fracturesashxsc_langdahashA867AD76B6ECFF5A7307A0C006E0938A
2 Rundgren J Bojan A Navarro CM et al Epidemiology classification treatment and mortality of distal radius fractures in adults an observational study of 23394 fractures from the national Swedish fracture register BMC Musculoskeletal Disorders 2020 2188
3 Stirling ERB Johnson NA Dias JJ Epidemiology of distal radius fractures in a geographically defined adult population J Hand Surg Eur Vol 2018439974-82
4 Berger AC Barvelink B Reijman M et al Does circumferential casting prevent fracture redisplacement in reduced distal radius fractures A retrospective multicentre study Journal of Orthopaedic Surgery and Research 2021 16722
5 Brogren E Petanek M and Atroshi I Incidence and characteristics of distal radius fractures in a southern Swedish region BMC Musculoskeletal Disorders
Background Each year about 20000 adult patients are treated for DRF in the Danish emergency departments across the country 1 Therefore the DRF is the most frequently treated fracture among adults in the Danish healthcare system As the population ages the number of DRF increases Furthermore the rate of surgical treatment of DRF increases independently probably due to an international change towards more interventional treatment favoring surgery above conservative treatment
The years up to 2013 a change was observed in the surgical method concerning treatment of DRF Internal fixation with a volar plate and screws increased at the expense of K-wires or external fixation This change is seen even based on sparse literature evidence 1
In the general population the distribution of DRFs is bimodal with the incidence peaks in young men - due to high energy trauma - and in postmenopausal women 2 The majority of DRFs in the second group are caused by a fall on an outstretched hand from ones upright position thus it is considered low-energy fractures There is a significant predominance of women to whom this type of fracture occurs which is connected to the fact that osteoporosis is an underlying cause 1 In a Swedish study Rundgren et al found that 78 of all DRFs occurred in women 2 while it was found in a British study that the rate of women to men was 6838 3
What does this trial add to current knowledge Through this study we aim to investigate the rate of DRFs initially treated with successful closed reduction to an acceptable position then immobilized in a plaster cast that re-displace and end up requiring surgery
This study will clarify the incidence of DRFs where surgical intervention could potentially be avoided if the initial closed reduction lasted until sufficient bone healing was attained As DRFs are the most common fracture of the adult population treated in the Danish emergency departments the aim of this study is to examine the amount of people with DRFs that could potentially avoid surgery and thereby lowering the cost to the health care system as well as save the patient invasive surgery Furthermore we expect to classify which specific types of fractures according to Arbeitsgemeinschaft für Osteosynthesefragen Orthopaedic Trauma Association AOOTA classification system have a high or low incidence of secondary surgery after primary closed reduction
Hypothesis We estimate the rate of surgical intervention of DRFs initially reduced to an acceptable position to be above 40
Aim The primary objective is to assess the rate of surgical treatment in adult patients with distal radial fractures initially reduced successfully managed in a single center according to the danish national clinical practice guidelines NCPG
Primary endpoint The purpose of this study is to determine the frequency of secondary displacement of DRFs initially treated with closed reduction and casting but subsequently resulting in secondary surgery
Secondary endpoints
We aim to compare the rate of DRF displacement following primary closed reduction found in this study with a similar cohort treated in the Netherlands 4
We will perform a sub analysis of risk of secondary displacement according to the Arbeitsgemeinschaft für Osteosynthesefragen AO classification system for DRFs
We will determine the frequency of DRFs with unacceptable position according to NCPG following initial reduction that are treated non-surgical
We will determine the number of reductions performed at the initial visit in the emergency department following a distal radius fracture per patient
Study Design This study will be conducted as a retrospective cohort study In addition outcomes from this study will be compared to outcomes from a comparable cohort from a previous retrospective study conducted in the Netherlands
Population Adult patients with displaced DRFs treated at North Zealand Hospital Nordsjællands Hospital NOH from 112018 to 31122019
Inclusion criteria Adult patients 18 years with a DRF DS252 DS252A DS252B DS252C and DS526 treated in the emergency department at NOH
Exclusion criteria
Concomitant fracture of the ulna except ulnar styloid process fractures
Non-displaced DRFs
Multiple trauma patients
Ipsilateral upper extremity fractures interfering with the treatment of the DRF Method Data will be retrieved from the electronic patient records Sundhedsplatformen SP Potential participants will be identified by relevant diagnosis codes DS252 DS252A DS252B DS252C and DS526 treated in the emergency department at NOH with closed reduction and an immobilizing cast from Jan 1st 2018 to Dec 31st 2019 We expect to include approximately 750 participants
Data relevant to the above-described outcomes ie radiologic data diagnosisprocedure codes and information from outpatient clinic visits and data relevant for baseline characteristics will be extracted from patient electronic journals and transferred to investigators
All extracted data will be transferred in pseudonymized form to an on-line data capturing system REDCAP
A team of orthopedic surgeons from the orthopedic department NOH will be asked to assess radiographic images from the initial visit to the emergency department to assess
Classification according to AO
Non-displaced yesno
Radiographic measurements according to httpswwwncbinlmnihgovpmcarticlesPMC4641087 radial shortening ulnar variance and volardorsal angulation
A comparable cohort from an ongoing prospective study of DRFs performed in the Netherlands has been identified and the responsible researcher has been contacted and agreed to provide data for a comparison of data between the two groups Data will be transferred in anonymized form to the primary investigator of this study and stored at a secure drive The primary and secondary outcomes outlined above will be compared across the two cohorts
Due to the study design it will be possible to repeat the study in other hospitals and compare the results across the Danish emergency departments as well as international
Statistical analysis Rate of DRF displacement following initial reduction and cast treatment is described with summary statistics
Categorical and ordinal variables will be presented in percentages of the analyzed group Continuous variables will be presented as mean followed by standard deviation If continuous variables were not normally distributed they will be presented as median with 25 and 75 quartiles and log transformed before further analysis
Categorical and ordinal variables are compared across groups using χ2 test Pearson test If a low number of expected frequencies is encountered Fishers exact test is used For analysis of differences in continuous variables between groups t-test will be carried out
Multiple regression will be performed to identify possible associations between relevant clinical variants and risk of DRF displacement following initial reduction and cast treatment
All statistical analyses will be performed in the SAS Studio 37 SAS Institute Inc Cary NC USA
Statistical significance is defined as a probability p-value lower than 5 Perspective The results of this study will allow us to clarify the number of patients with DRF where surgery could potentially be avoided If a specific group of patients determined radiologically due to AO-classifications with larger risk of DRF displacement following initial reduction and cast treatment is identified there would be a great incentive to improve the treatment of this group In addition the comparison with a cohorte from the Netherlands will allow us to identify international differences in treatment and diagnosis of DRFs The results of this study may eventually lead to a reduction in surgical treatment of DRFs and thereby a possible reduction in cost in relation to DRF treatment to the society
Quality control and monitoring The study will be conducted in accordance with the Helsinki declaration on Ethical Principles for Medical Research Involving Human Subjects The principles of Good Clinical Practice were followed throughout the study
The STROBE guidelines will be followed in the initiation data handling and presentation of the study
The study protocol will be registered in the The ISRCTN registry before initiation
No monitoring of the study is needed or planned of this retrospective cohort study As the radiographic data for each patient has been evaluated by orthopedic consultant or senior registrar at least three times initially in emergency department day after at conference in out-patient clinic andor in the operating theater we deem it highly unlikely that any new findings of clinical relevance should happen In the unlikely event that a new clinical finding should be done we will consult the local radiograph responsible for orthopedic radiology at NOH
Ethical considerations and data safety To protect the patients privacy and integrity data will be extrapolated from SP and pseudonymized and it will not be possible to identify the individuals This study will not have any effect on the treatment or outcome for the patient cohort but will solely help to identify improvements of future treatments This study will investigate potential areas of DRF treatment where improvement can be made to potentially avoid surgery in this large fragile population
Ethical committee approval Before the study is initiated approval from relevant ethical and data security agencies will be attained National Videnskabsetisk Komite Sundhedsdatastyrelsen Forskerservice and the Danish Data Protection Agency httpssundhedsdatastyrelsendkdaforskerserviceansog-om-data
Recruitment As this is a retrospective cohort study there is no need to recruit patients as the data needed can be found in the electronic patient records
Economy There is no funding for this project as well as no sponsors or donors The primary investigator and all secondary investigators are unpaid and perform the investigation in their spare-time Except the clinically responsible investigator Jonas Askø Andersen who is head of research in the Orthopedic department in North Zealand Hospital
Dissemination of results We expect to complete the data- and statistical analysis in September 2022 At this point the data and conclusion will be published in an international or national peer-reviewed medical journal Both positive negative and inconclusive data will be published In addition data from the study will be presented at national and international conferences if possible Should publication in a peer-reviewed journal not be possible data will be published in an open access database
Patient information As this study does not add new treatments or diagnostic methods to the patients involved and does not use individual or patient identifiable data we have applied for data access without written consent from included individuals and therefore patient information has been deemed unnecessary
References
1 httpswwwsstdk-mediaUdgivelser2014NKR-HC3A5ndledsnC3A6re-underarmsbrudNational-clinical-guideline-on-the-treatment-of-distal-radial-fracturesashxsc_langdahashA867AD76B6ECFF5A7307A0C006E0938A
2 Rundgren J Bojan A Navarro CM et al Epidemiology classification treatment and mortality of distal radius fractures in adults an observational study of 23394 fractures from the national Swedish fracture register BMC Musculoskeletal Disorders 2020 2188
3 Stirling ERB Johnson NA Dias JJ Epidemiology of distal radius fractures in a geographically defined adult population J Hand Surg Eur Vol 2018439974-82
4 Berger AC Barvelink B Reijman M et al Does circumferential casting prevent fracture redisplacement in reduced distal radius fractures A retrospective multicentre study Journal of Orthopaedic Surgery and Research 2021 16722
5 Brogren E Petanek M and Atroshi I Incidence and characteristics of distal radius fractures in a southern Swedish region BMC Musculoskeletal Disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None