Clinical trial NCT04748016: 3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Humerus Fracture
Distal Femur Fracture
Distal Tibia Fracture
Proximal Humeral Fracture
Keywords: 3D Printing
Intra-articular Fracture
Patient-specific instrumentation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind randomised control trial with 40 patients in two interventional arm
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of articular surface reduction grading assessed by three-point scale
timeFrame: Immediately post-operation
measure: Skin to skin duration of surgery (minutes)
timeFrame: Immediately post-operation
Secondary outcomes:
measure: Total fluoroscopy time (seconds)
timeFrame: Immediately post-operation
measure: Intraoperative blood loss (mL)
timeFrame: Immediately post-operation
measure: Total length of skin incision (mm)
timeFrame: Immediately post-operation
measure: Total tourniquet time (minutes)
timeFrame: Immediately post-operation
measure: Incidence of surgical complications
timeFrame: 3 months post-operation
measure: Quality of articular surface reduction grading assessed by three-point scale
timeFrame: 3 months post operation
measure: Health-related quality of life measured by SF-12 Chinese (HK) version
timeFrame: 3 months post-operation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
Study officials:
affiliation: Dept of Orthopaedics and Traumatology, Queen Mary Hospital
name: Christian Fang
role: PRINCIPAL_INVESTIGATOR
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