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

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: Distal Tibia Fracture; Proximal Humeral Fracture; Distal Femur Fracture; Distal Humerus Fracture

Treatments: Other: 3D printed (3DP) bone models + CT imaging; Other: CT imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT04748016

UW 18-480

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

3D-printed models plus CT imaging

Experimental group

Description:

Fracture repair surgery using sterilized 3DP models, CT-MPR and CT-3DR for planning and intraoperative visualization

Treatment:

Other: 3D printed (3DP) bone models + CT imaging

CT imaging alone

Active Comparator group

Description:

Fracture repair surgery using CT-MPR and CT-3DR for planning and intraoperative visualization

Treatment:

Other: CT imaging