Distal Humerus Fracture, Distal Femur Fracture, Distal Tibia Fracture, Proximal Humeral Fracture
Conditions
Keywords
3D Printing, Intra-articular Fracture, Patient-specific instrumentation
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 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.
Interventions
OTHER3D 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.
OTHERCT imaging
CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are randomly assigned to either one of the interventional arm and will not be informed of the randomisation result. A blinded reviewer will assess the postoperative radiographs and surgical quality.
Intervention model description
Double-blind randomised control trial with 40 patients in two interventional arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. age 18 years or older 2. with intra-articular fracture of the proximal or distal humerus, proximal ulna, proximal radius, distal femur, or proximal or distal tibia (pilon fracture) 3. requiring anticipated surgical repair of fracture 4. with pre-operative CT scan already available as part of routine assessment
Exclusion criteria
1. pathological fracture 2. multiple fractures requiring simultaneous or staged operations 3. fractures around the hip, pelvis and acetabulum, and any other fracture types not specified in the inclusion criteria 4. requiring surgery within 24 hours of admission 5. unable or unwilling to give consent to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of articular surface reduction grading assessed by three-point scale | Immediately post-operation | 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) |
| Skin to skin duration of surgery (minutes) | Immediately post-operation | The skin to skin duration of the surgery will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total length of skin incision (mm) | Immediately post-operation | The total length on the incision will be measured post operation. |
| Total tourniquet time (minutes) | Immediately post-operation | Total time the tourniquet was applied will be recorded. |
| Total fluoroscopy time (seconds) | Immediately post-operation | The total intraoperative fluoroscopy time will be recorded in seconds. |
| Quality of articular surface reduction grading assessed by three-point scale | 3 months post operation | 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) |
| Health-related quality of life measured by SF-12 Chinese (HK) version | 3 months post-operation | 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). |
| Incidence of surgical complications | 3 months post-operation | Incidence of infection, neurological deficit, wound breakdown, loss of fixation, revision surgery will be recorded at follow up. |
| Intraoperative blood loss (mL) | Immediately post-operation | The patient's blood loss during the surgery will be recorded. |
Countries
Hong Kong
Contacts
Primary ContactChristian Fang
Outcome results
None listed