Distal Radius FractureDORSALNCT03635060
Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating
A study testing Dorsal Bridge Plating and Volar locking plating in people with Distal Radius Fracture, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Optimal fixation for highly comminuted distal radius fractures with metadiaphyseal extension remains to be a major treatment challenge for orthopaedic surgeons. The purpose of this study is to determine the safety, feasibility and sample size estimations for a larger, definitive study comparing functional outcomes of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Dorsal Bridge Plating and Volar locking plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2018to 30 Jun 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over the age of 18 years
- Diagnosed with unilateral or bilateral, open or closed, severely comminuted distal radius fractures (fracture classification of AO.23-C2 and AO.23-C3)
- Scheduled to undergo surgery
Who cannot join
- Previous wrist injuries or surgery that would compromise performance of either procedure.
- Surgery delayed beyond 21 days from injury.
- Significant medical comorbidities.
- Neurologic injury causing paralysis of affected arm.
- Those unable to attend follow up and comply with the post-operative protocol
Trial locations and contacts
1 site in 1 country.
About this study
Optimal fixation for highly comminuted distal radius fractures with metadiaphyseal extension remains to be a major treatment challenge for orthopaedic surgeons. The purpose of this study is to determine the safety, feasibility and sample size estimations for a larger, definitive study comparing functional outcomes of patients treated with dorsal distraction plate fixation with or without fragment specific fixation to standard open reduction internal fixation in highly comminuted distal radius fractures (subtypes AO.23-C2 and AO.23-C3). The study design will be a pilot randomized control trial. Fracture pattern eligibility will be determined by consensus agreement between two fellowship trained upper extremity specialists. The primary outcome measure will be the QuickDASH score. Secondary outcome measures include wrist range of motion, grip strength, Visual Analog Scale pain scale, Short Form SF-12, and EQ-5D. Ultimately, this study will lead to a larger randomized control trial and result in improvement in the care and treatment of patients with these challenging injuries.
Read the detailed description
Distal radius fractures are the most common long bone fractures and the incidence appears to be increasing worldwide. They have been found to account for approximately 17% of all fracture related emergency department visits. These types of injuries have a bimodal age distribution. The first cohort consists of elderly patients with lower to moderate energy injuries secondary to osteoporosis, and the second cohort consists of young patients involved in high energy traumas.
Surgical treatment for distal radius fractures varies, as there are numerous techniques for fixation. The goals of fixation are anatomic reduction and stability, as this has been shown to result in improved chances for functional recovery. The use of volar distal radius locking plates has become the standard for treatment of the majority of low-energy distal radius fractures. However, adequate fixation for high energy comminuted fractures with or without metadiaphyseal extension remains a major treatment challenge. Severely comminuted articular fractures are problematic in terms of obtaining an adequate reduction and/or stabilization by the standard periarticular plate. It is in this light that the dorsal distraction plate can serve as an improved fixation device by allowing comminuted articular fragments reduce under ligamentotaxis. In addition, periarticular plate fixation cannot address proximal comminution. Furthermore, the use of external fixation has fallen out of favour due to the high complication rate associated with pin track infections resulting in loosening and loss of reduction. It has been reported that highly comminuted distal radius fractures are associated with a 52% to 63% complication rate when treated with external fixation. Recently, there has been increased use of dorsal distraction plating for these types of injuries however, the literature to date is quite limited. Unlike external fixation, the bridge plate can be left in place for an extended period of time without the risk of the aforementioned complications.
Burke and Singer were the first to describe use of internal distraction plating for treatment of comminuted, displaced distal radius fractures in 1998. Since then, the literature on outcomes after dorsal distraction plating has been limited to retrospective reviews except for one prospective series by Ruch et al in 2005. The rationale for an internal spanning plate is multifactorial. Firstly, it is an extremely stable construct and more rigid than an external fixator. Secondly, due to the extensive time required for bone healing (approximately 12 weeks), in these injuries, the internal distraction plate can remain in situ until full union has completed. Lastly, this method allows for early weight bearing and transfer in polytraumas patients with pelvic or lower extremity injuries.
Despite the increasing use of dorsal distraction plating for these types of injuries, there has not been a proper analysis comparing dorsal distraction plating to standard open reduction internal fixation volar plating. Furthermore, most of the studies in the literature have varied in terms of outcome assessment. Much of the current literature has found that this type of fixation results in restoration of functional range of motion with minimal complications rates. More detailed information regarding outcomes following this type of fixation may help improve functional outcomes post-injury as well as improve mobilization in polytrauma patients. Using a comprehensive approach to evaluating patients, the investigators aim to initially perform a retrospective case series study of patients treated with dorsal distraction plating versus open reduction internal fixation volar plating. Once completed, the investigators plan to perform a pilot randomized control trial comparing the same groups described previously for AO.23-C2 and AO.23-C3 distal radius fractures.
The aim of this study is to evaluate the use of dorsal distraction plating alone or combined with any other fragment specific fixation in the treatment of severely comminuted distal radius fractures with metadiaphyseal extension (AO.23-C2 and AO.23-C3) and compare outcomes to those treated with open reduction internal fixation.
The investigators hypothesize that highly comminuted distal radius fractures with metadiaphyseal extension treated with dorsal distraction plating result in restoration of function as well as improved outcomes compared to those treated with standard open reduction internal fixation.
- Conditions
- Distal Radius Fracture
- Being tested
- Dorsal Bridge Plating, Volar locking plating
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsal Bridge PlatingProcedure or surgery
This study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation.
Volar locking platingProcedure or surgery
This study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation.
| Study group | Role | What they receive |
|---|---|---|
| Dorsal Bridge Plating | Active comparator | The intervention is surgery with dorsal distraction plating with or without any additional fragment specific fixation. Receives: Procedure: Dorsal Bridge Plating |
| Volar Locking Plating | Active comparator | The intervention is surgery with open reduction and internal fixation with non-spanning fixation. Receives: Procedure: Volar locking plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH
It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level.
Measured: primary outcome assessed at 1 year following surgery (survey done at each followup starting at week 6)
Secondary outcomes (2)
Change in Patient-Related Wrist Evaluation
The Patient Related Wrist Evaluation is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living. Developed in 1998 for clinical assessment and is used for specific wrist problems. It is one of the reliable upper extremity outcome instruments.
Measured: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery
EQ-5D
A standardized instrument for measuring generic health status. The health status measured with EQ-5D is used for estimating preference weight for that health status, then by combining the weight with time, quality-adjusted life year (QALY) can be computed. QALYs gained is used as an outcome in cost-utility analysis which is a type of economic evaluation that compares the benefit and cost of health care programs or interventions.
Measured: 6 weeks, 3 months, 6 months, and 1 year following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start12 Sep 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Patrick Henry, Sunnybrook Health Sciences Centre
- Investigators
- Patrick Henry, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635060
- Sponsor's protocol ID
- DORSAL
- Acronym
- DORSAL
- Status last verified
- Apr 2023
- First submitted
- 9 Aug 2018
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating
- ClinicalTrials.gov ID
- NCT03635060
- Acronym / sponsor ID
- DORSAL / DORSAL
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
Optimal fixation for highly comminuted distal radius fractures with metadiaphyseal extension remains to be a major treatment challenge for orthopaedic surgeons. The purpose of this study is to determine the safety, feasibility and sample size estimations for a larger, definitive study comparing functional outcomes of patients treated with dorsal distraction plate fixation with or without fragment specific fixation to standard open reduction internal fixation in highly comminuted distal radius fractures (subtypes AO.23-C2 and AO.23-C3). The study design will be a pilot randomized control trial. Fracture pattern eligibility will be determined by consensus agreement between two fellowship trained upper extremity specialists. The primary outcome measure will be the QuickDASH score. Secondary outcome measures include wrist range of motion, grip strength, Visual Analog Scale pain scale, Short Form SF-12, and EQ-5D. Ultimately, this study will lead to a larger randomized control trial and result in improvement in the care and treatment of patients with these challenging injuries.
Detailed description
Distal radius fractures are the most common long bone fractures and the incidence appears to be increasing worldwide. They have been found to account for approximately 17% of all fracture related emergency department visits. These types of injuries have a bimodal age distribution. The first cohort consists of elderly patients with lower to moderate energy injuries secondary to osteoporosis, and the second cohort consists of young patients involved in high energy traumas.
Surgical treatment for distal radius fractures varies, as there are numerous techniques for fixation. The goals of fixation are anatomic reduction and stability, as this has been shown to result in improved chances for functional recovery. The use of volar distal radius locking plates has become the standard for treatment of the majority of low-energy distal radius fractures. However, adequate fixation for high energy comminuted fractures with or without metadiaphyseal extension remains a major treatment challenge. Severely comminuted articular fractures are problematic in terms of obtaining an adequate reduction and/or stabilization by the standard periarticular plate. It is in this light that the dorsal distraction plate can serve as an improved fixation device by allowing comminuted articular fragments reduce under ligamentotaxis. In addition, periarticular plate fixation cannot address proximal comminution. Furthermore, the use of external fixation has fallen out of favour due to the high complication rate associated with pin track infections resulting in loosening and loss of reduction. It has been reported that highly comminuted distal radius fractures are associated with a 52% to 63% complication rate when treated with external fixation. Recently, there has been increased use of dorsal distraction plating for these types of injuries however, the literature to date is quite limited. Unlike external fixation, the bridge plate can be left in place for an extended period of time without the risk of the aforementioned complications.
Burke and Singer were the first to describe use of internal distraction plating for treatment of comminuted, displaced distal radius fractures in 1998. Since then, the literature on outcomes after dorsal distraction plating has been limited to retrospective reviews except for one prospective series by Ruch et al in 2005. The rationale for an internal spanning plate is multifactorial. Firstly, it is an extremely stable construct and more rigid than an external fixator. Secondly, due to the extensive time required for bone healing (approximately 12 weeks), in these injuries, the internal distraction plate can remain in situ until full union has completed. Lastly, this method allows for early weight bearing and transfer in polytraumas patients with pelvic or lower extremity injuries.
Despite the increasing use of dorsal distraction plating for these types of injuries, there has not been a proper analysis comparing dorsal distraction plating to standard open reduction internal fixation volar plating. Furthermore, most of the studies in the literature have varied in terms of outcome assessment. Much of the current literature has found that this type of fixation results in restoration of functional range of motion with minimal complications rates. More detailed information regarding outcomes following this type of fixation may help improve functional outcomes post-injury as well as improve mobilization in polytrauma patients. Using a comprehensive approach to evaluating patients, the investigators aim to initially perform a retrospective case series study of patients treated with dorsal distraction plating versus open reduction internal fixation volar plating. Once completed, the investigators plan to perform a pilot randomized control trial comparing the same groups described previously for AO.23-C2 and AO.23-C3 distal radius fractures.
The aim of this study is to evaluate the use of dorsal distraction plating alone or combined with any other fragment specific fixation in the treatment of severely comminuted distal radius fractures with metadiaphyseal extension (AO.23-C2 and AO.23-C3) and compare outcomes to those treated with open reduction internal fixation.
The investigators hypothesize that highly comminuted distal radius fractures with metadiaphyseal extension treated with dorsal distraction plating result in restoration of function as well as improved outcomes compared to those treated with standard open reduction internal fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal Bridge Plating | Active comparator | Procedure: Dorsal Bridge PlatingThe intervention is surgery with dorsal distraction plating with or without any additional fragment specific fixation. |
| Volar Locking Plating | Active comparator | Procedure: Volar locking platingThe intervention is surgery with open reduction and internal fixation with non-spanning fixation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over the age of 18 years
- Diagnosed with unilateral or bilateral, open or closed, severely comminuted distal radius fractures (fracture classification of AO.23-C2 and AO.23-C3)
- Scheduled to undergo surgery
Key exclusion criteria (5 listed)
- Previous wrist injuries or surgery that would compromise performance of either procedure.
- Surgery delayed beyond 21 days from injury.
- Significant medical comorbidities.
- Neurologic injury causing paralysis of affected arm.
- Those unable to attend follow up and comply with the post-operative protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dorsal Bridge PlatingThis study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation. | Procedure or surgery | Dorsal Bridge Plating |
| Volar locking platingThis study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation. | Procedure or surgery | Volar Locking Plating |
Primary outcome
QuickDASH
Time frame: primary outcome assessed at 1 year following surgery (survey done at each followup starting at week 6)
It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level.
2 secondary outcomes
Change in Patient-Related Wrist Evaluation
Time frame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following surgery
EQ-5D
Time frame: 6 weeks, 3 months, 6 months, and 1 year following surgery
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 3 May 2023.
- Individual participant dataSharing planned: No
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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.
Patrick Henry principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsal Bridge Plating and Volar locking plating in people with Distal Radius Fracture, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 3 inclusion and 5 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 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
QuickDASH (time frame: primary outcome assessed at 1 year following surgery (survey done at each followup starting at week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2023.