NCT04748016

3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 patient's 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.

Conditions

• Distal Humerus Fracture
• Distal Femur Fracture
• Distal Tibia Fracture
• Proximal Humeral Fracture

Interventions

Type	Name	Description
OTHER	3D printed (3DP) bone models + CT imaging	In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
OTHER	CT imaging	CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.

Timeline

• Start date: 2020-03-13
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-02-10
• Last updated: 2022-07-20

Locations

1 site across 1 country: Hong Kong