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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGQuality 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)
Time frame: Immediately post-operation
Skin to skin duration of surgery (minutes)
The skin to skin duration of the surgery will be recorded.
Time frame: Immediately post-operation
Total fluoroscopy time (seconds)
The total intraoperative fluoroscopy time will be recorded in seconds.
Time frame: Immediately post-operation
Intraoperative blood loss (mL)
The patient's blood loss during the surgery will be recorded.
Time frame: Immediately post-operation
Total length of skin incision (mm)
The total length on the incision will be measured post operation.
Time frame: Immediately post-operation
Total tourniquet time (minutes)
Total time the tourniquet was applied will be recorded.
Time frame: 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.
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Time frame: 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)
Time frame: 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).
Time frame: 3 months post-operation