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

NCT04748016 | Unknown DMC

• 1 other identifier: UW 18-480
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

3D Printing; Intra-articular Fracture; Patient-specific instrumentation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Total fluoroscopy time (seconds)

  Immediately post-operation

• Intraoperative blood loss (mL)

  Immediately post-operation

• Total length of skin incision (mm)

  Immediately post-operation

• Total tourniquet time (minutes)

  Immediately post-operation

• Incidence of surgical complications

  3 months post-operation

Study Arms (2)

3D-printed models plus CT imaging

EXPERIMENTAL

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

CT imaging alone

ACTIVE COMPARATOR

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

Other: CT imaging

Interventions

3D printed (3DP) bone models + CT imaging OTHER

In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.

3D-printed models plus CT imaging

CT imaging OTHER

CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.

CT imaging alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pathological fracture
• multiple fractures requiring simultaneous or staged operations
• requiring surgery within 24 hours of admission
• unable or unwilling to give consent to participate

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Humeral Fractures, Distal; Femoral Fractures, Distal; Shoulder Fractures; Intra-Articular Fractures

Interventions

Postmortem Imaging

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Humeral Fractures; Fractures, Bone; Femoral Fractures; Leg Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Christian Fang

  Dept of Orthopaedics and Traumatology, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Fang

CONTACT

22554581; cfang@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Double-blind randomised control trial with 40 patients in two interventional arm

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: March 13, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Within 1 year of study completion
• Access Criteria: Additional information available upon reasonable request of principal investigator

Locations

HK (1)