Computer-Assisted Jaw Reconstruction Using 3D-Printed Patient-Specific Surgical Plates Versus Conventional Surgical Plates: A Randomised Controlled Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: The aim of this randomised controlled clinical trial is to evaluate surgical accuracy and efficiency of computer-assisted jaw reconstruction using 3D-printed patient-specific titanium surgical plates versus conventional plates. Hypothesis to be tested: The investigators hypothesize that compared to conventional surgical plates, 3D-printed patient-specific surgical plates improve surgical accuracy and efficiency of computer assisted jaw reconstruction. Design and subjects: This is an open-label, prospective, double-arm, and single-centre randomised controlled clinical trial. Patients with maxillary or mandibular neoplastic, inflammatory and congenital diseases who require immediate or secondary reconstructive surgery will be invited to participate in the study. Study instruments: 3D-printed patient-specific titanium surgical plates and conventional plates. Main Outcome Measures: The primary endpoint is the accuracy of reconstruction. The secondary endpoints include the accuracy of osteotomy, reconstruction time, total operative time, intraoperative blood loss, length of post-operative hospital stay, and postoperative adverse events. Data analysis: The accuracy parameters, reconstruction time, total operative time, intraoperative blood loss, length of post-operative hospital stay will be presented as mean values with standard deviations. The post-operative adverse events will be calculated and presented as frequency with standard deviation. Expected results: This randomised control trial will prove improved accuracy and efficiency of reconstruction using 3D printed patient-specific titanium surgical plates. This study is expected to provide high-level evidence to push forward the popularity of using 3D medical printing technology in surgical field.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than 18 years, of both gender;

• Provision of signed and dated informed consent form;

• Diagnosed with maxillofacial benign or malignant tumours or inflammatory or congenital diseases and indicated for computer-assisted jaw surgery;

• Primary or secondary reconstruction with autogenous bony free flaps or graft will be needed;

• Titanium plates will be used for internal fixation for the reconstruction surgery;

• Agree to comply with follow-up procedures.

Locations
Other Locations
Hong Kong Special Administrative Region
The Prince Philip Dental Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Yuxiong Su, Dr.
richsu@hku.hk
852 2859 0267
Time Frame
Start Date: 2020-12-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 92
Treatments
Experimental: 3D-printed patient-specific plate group
3D-printed patient-specific plate will be used for reconstruction in this patient group
Active_comparator: Conventional plate group
conventional commercial plates will be used for reconstruction in this patient group
Related Therapeutic Areas
Sponsors
Leads: The University of Hong Kong

This content was sourced from clinicaltrials.gov

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