Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT03635060
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Study Overview
Official Title:
Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating
Status:
COMPLETED
Status Verified Date:
2023-04
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:
DORSAL
Brief 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 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.
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 Oversight
Has Oversight DMC:
False
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?: