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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Distal Humerus Fracture, Distal Femur Fracture, Distal Tibia Fracture, Proximal Humeral Fracture

Intervention / Treatment
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* Other: 3D printed (3DP) bone models + CT imaging
* Other: CT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture) requiring anticipated surgical repair of fracture with pre-operative CT scan already available as part of routine assessment Exclusion Criteria: pathological fracture multiple fractures requiring simultaneous or staged operations fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria requiring surgery within 24 hours of admission unable or unwilling to give consent to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind randomised control trial with 40 patients in two interventional arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed models plus CT imaging<br>Fracture repair surgery using sterilized 3DP models, CT-MPR and CT-3DR for planning and intraoperative visualization | Other: 3D printed (3DP) bone models + CT imaging<br>* In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.<br>|
| Active Comparator: CT imaging alone<br>Fracture repair surgery using CT-MPR and CT-3DR for planning and intraoperative visualization | Other: CT imaging<br>* CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of articular surface reduction grading assessed by three-point scale | The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images. The Kappa value will be recorded for inter-observer agreement between two observers (1. Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm) | Immediately post-operation | 
| Skin to skin duration of surgery (minutes) | The skin to skin duration of the surgery will be recorded. | Immediately post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total fluoroscopy time (seconds) | The total intraoperative fluoroscopy time will be recorded in seconds. | Immediately post-operation | 
| Intraoperative blood loss (mL) | The patient's blood loss during the surgery will be recorded. | Immediately post-operation | 
| Total length of skin incision (mm) | The total length on the incision will be measured post operation. | Immediately post-operation | 
| Total tourniquet time (minutes) | Total time the tourniquet was applied will be recorded. | Immediately post-operation | 
| Incidence of surgical complications | Incidence of infection, neurological deficit, wound breakdown, loss of fixation, revision surgery will be recorded at follow up. | 3 months post-operation | 
| Quality of articular surface reduction grading assessed by three-point scale | The quality of articular surface reduction will be rated by two surgeons blinded to intervention allotment assessing post-operative and intraoperative fluoroscopic images. The Kappa value will be recorded for inter-observer agreement between two observers (1. Perfect reduction, 2. Observable imperfections 1-2mm, 3. Significant imperfections >2mm) | 3 months post operation | 
| Health-related quality of life measured by SF-12 Chinese (HK) version | 12-item Short Form Health Survey (SF-12), a patient-reported outcome measure of HRQOL comprised of a mental component (MCS) and physical component (PCS), each with a final score ranging from 0 (worst outcome) to 100 (best outcome). | 3 months post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Printing, Intra-articular Fracture, Patient-specific instrumentation