Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-12
Brief Title:
IM Screw vs K-wire Fixation of ProximalMiddle Phalanx Fractures
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
Intramedullary Screw Versus Kirschner Wire Fixation of Extraarticular Proximal and Middle Phalanx Fractures Pilot Study for a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
HANDFIX
Brief Summary:
When people break their fingers sometimes surgery is needed to align the bones to heal them properly There are different ways to fix broken bones in hands such as plates pins or screws Each method has pros and cons fixing a broken bone with plates is usually a larger surgery with more cutting but holds the bones very securely Pins require little to no cutting but the patient needs to immobilize their hand for a few weeks afterwards Screws are a newer method of fixing broken fingers that requires little cutting and also holds the bones securely The goal of this study is to compare the effectiveness of using pins versus screws in surgery for broken fingers The investigators are studying whether using screws leads to better hand function patient satisfaction and quicker return to work
Detailed Description:
Hand fractures are one of the most common skeletal injuries and affect a wide range of the population Commonly affected groups include children and young adults with sports-related injuries manual labourers with work-related injuries and the elderly Although the majority of phalanx fractures may be managed conservatively with good outcomes operative fixation is indicated for significantly displaced or unstable fracture patterns and those causing malrotation and scissoring
There are a variety of options for operative fixation of proximal and middle phalanx fractures which include closed versus open reduction CR vs OR with percutaneous pinning PP or internal fixation IF techniques Kirschner wires K-wire and platesscrews are the most common CRPP and ORIF techniques K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply However patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection Conversely ORIF with platesscrews provide rigid fixation allowing for early mobilization but require opening of fracture site and often periosteal stripping Complications with ORIF include adhesions and stiffness
There is emerging evidence for the effectiveness of intramedullary IM screw fixation as an alternative technique for IF IM screw fixation is a minimally invasive technique that provides rigid fixation of fractures acting as an internal splint and load-sharing device Its biomechanical properties have been well-described in the lower extremity orthopedic literature IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications Small observational cohort studies have shown favourable outcomes in return to activity range of motion time to radiological healing and grip strength However the investigators literature search revealed a paucity of high quality studies comparing the effectiveness of IM screws with K-wires or other methods of fixation
The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial comparing two CR techniques ie IM screw fixation to K-wire fixation in adult patients with extraarticular proximal or middle phalanx fracture at the investigators tertiary academic hospital The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation
There are a variety of options for operative fixation of proximal and middle phalanx fractures which include closed versus open reduction CR vs OR with percutaneous pinning PP or internal fixation IF techniques Kirschner wires K-wire and platesscrews are the most common CRPP and ORIF techniques K-wires allow for fracture fixation with minimal soft tissue injury and preserved blood supply However patients require prolonged postoperative immobilization and are at risk of malunion and pin tract infection Conversely ORIF with platesscrews provide rigid fixation allowing for early mobilization but require opening of fracture site and often periosteal stripping Complications with ORIF include adhesions and stiffness
There is emerging evidence for the effectiveness of intramedullary IM screw fixation as an alternative technique for IF IM screw fixation is a minimally invasive technique that provides rigid fixation of fractures acting as an internal splint and load-sharing device Its biomechanical properties have been well-described in the lower extremity orthopedic literature IM screw fixation may allow for early mobilization without the operative site morbidity of open reduction and its associated complications Small observational cohort studies have shown favourable outcomes in return to activity range of motion time to radiological healing and grip strength However the investigators literature search revealed a paucity of high quality studies comparing the effectiveness of IM screws with K-wires or other methods of fixation
The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial comparing two CR techniques ie IM screw fixation to K-wire fixation in adult patients with extraarticular proximal or middle phalanx fracture at the investigators tertiary academic hospital The secondary objective will be to describe early clinical outcomes which can be used for future trial sample size calculation
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