Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748016
Status:
UNKNOWN
Last Update Posted:
2022-07-20
First Post:
2021-02-05
Brief Title:
3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Sterilised 3D-PRINTed Bone Models in Addition to Conventional CT Imaging for Operative Visualisation in Complex Intra-articular Fracture Repair - A Multi-centre Double-blind Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
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:
SPRINT
Brief Summary:
The purpose of this study is to compare the effectiveness of 3D-printed bone models in addition to CT imaging versus CT imaging alone on surgical quality and operation time for patients undergoing surgical repair of intra-articular fractures
Detailed Description:
Surgical fixation of intra-articular fractures is a technically demanding task that poses significant challenges to orthopaedic surgeons Articular fragments may be comminuted depressed or impacted and neighbouring soft tissue is often heavily compromised Furthermore aggressive surgical dissection is typically necessary to achieve adequate visualisation and anatomical reduction often devitalises bone fragments and invites deep infection The management of intra-articular fractures requires a well-designed preoperative plan and a skilfully executed surgical tactic to guarantee the best possible outcome Multiplanar reformation CT-MPR and three-dimensional reconstruction CT-3DR are imaging techniques that have enhanced intraoperative visualisation however accurate analysis of complex fractures remains challenging
3D printing is a rapidly developing low-cost technology that is already being applied across numerous contexts in orthopaedics and traumatology 3D printed bone models can be produced from digitised CT data in a matter of hours providing a dimensionally accurate representation of the patients skeleton which approximates real-life visual and tactile experiences When used in preoperative planning these models have shown to improve surgeon communication and shorten surgical duration Despite positive early results few clinical studies have studied the effect of 3D bone model use on surgical outcome The purpose of this randomised controlled trial is to compare the effectiveness of intraoperatively utilised 3D bone models in addition to conventional CT imaging on reduction quality and surgical duration versus CT imaging alone for patients undergoing surgical fixation of complex intraarticular fractures
Patients providing informed consent will be screened for eligibility All eligible patients will be randomly assigned in a double-blind manner participant and outcome assessor to receive surgical fracture fixation with or without the addition of sterilised 3D-printed bone models to standard CT imaging for intraoperative visualisation
3D printing is a rapidly developing low-cost technology that is already being applied across numerous contexts in orthopaedics and traumatology 3D printed bone models can be produced from digitised CT data in a matter of hours providing a dimensionally accurate representation of the patients skeleton which approximates real-life visual and tactile experiences When used in preoperative planning these models have shown to improve surgeon communication and shorten surgical duration Despite positive early results few clinical studies have studied the effect of 3D bone model use on surgical outcome The purpose of this randomised controlled trial is to compare the effectiveness of intraoperatively utilised 3D bone models in addition to conventional CT imaging on reduction quality and surgical duration versus CT imaging alone for patients undergoing surgical fixation of complex intraarticular fractures
Patients providing informed consent will be screened for eligibility All eligible patients will be randomly assigned in a double-blind manner participant and outcome assessor to receive surgical fracture fixation with or without the addition of sterilised 3D-printed bone models to standard CT imaging for intraoperative visualisation
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