3D-Printed Patient-Specific Surgical Plates Versus Conventional Surgical Plates in Jaw Reconstruction

NCT04635865 | Active Not Recruiting

• 1 other identifier: UW 20-548
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mandibular Neoplasms; Maxillary Neoplasms; Dentofacial Deformities

Keywords

3D printing; patient-specific titanium plate; mandibular malignancy; dento-maxillofacial deformity; mandibular reconstruction; maxillary reconstruction

Outcome Measures

Primary Outcomes (1)

• Accuracy of reconstruction

  The primary endpoint is accuracy of reconstruction, which is defined as the distance or angulation deviations of anatomical landmarks between the virtual plan and actual surgical outcome.

  through study completion, an average of 5 years

Secondary Outcomes (6)

• accuracy of osteotomy

  after surgery for each case, through study completion, an average of 5 years

• reconstruction time

  during surgery for each case, through study completion, an average of 5 years

• total operative time

  during surgery for each case, through study completion, an average of 5 years

• intraoperative blood loss

  during surgery for each case, through study completion, an average of 5 years

• length of post-operative hospital stay

  after surgery for each case, through study completion, an average of 5 years

Study Arms (2)

3D-printed patient-specific plate group

EXPERIMENTAL

3D-printed patient-specific plate will be used for reconstruction in this patient group

Device: 3D-printed patient-specific plate

Conventional plate group

ACTIVE COMPARATOR

conventional commercial plates will be used for reconstruction in this patient group

Device: Conventional commercial reconstruction plate

Interventions

3D-printed patient-specific plate DEVICE

We adopt an in-house approach for designing by surgeons. All patient-specific devices are designed in 3-matic 13.0 (Materialise). Both cutting and transferring guides are then additively manufactured by Fused Deposition Manufacturing (FDM) using ULTEM 1010, or by Stereolithography using MED610 resin (Stratasys Ltd, Eden Prairie, MN, USA). Both ULTEM 1010 and MED610 are FDA cleared biocompatible materials applicable to high-temperature autoclaving. Patient-specific surgical plates are designed by delineating a plate path on bone surface, then followed by the placement of screw holes. Surgical plates are generated by the built-in command in 3-matic. After that, surgical plates are fabricated by SLM using grade 2 titanium powder.

3D-printed patient-specific plate group

Conventional commercial reconstruction plate DEVICE

Bone segments will be stabilized using commercial titanium surgical plates (DePuy Synthes, United States), which are bent manually before fastening the screws.\[

Conventional plate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are pregnant;
• Patients who have medically compromised conditions and cannot tolerate the surgery;
• Systemic conditions or diseases that violate the normal bone healing;
• Patients who are unable to take the preoperative and postoperative CT/CBCT scans;
• Patients who are unable to have a two-week period prior to surgery, for virtual surgery simulation, 3D patient-specific surgical plate design and fabrication.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The Prince Philip Dental Hospital

Hong Kong, 000000, Hong Kong

Location

Related Publications (14)

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MeSH Terms

Conditions

Mandibular Neoplasms; Maxillary Neoplasms; Dentofacial Deformities

Condition Hierarchy (Ancestors)

Jaw Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Mandibular Diseases; Stomatognathic Diseases; Maxillary Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yuxiong Su, Dr.

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Patients fulfilling the eligibility criteria and willing to participate will be randomised after baseline assessment (1:1 allocation ratio). A priori, an independent statistician will prepare a computer-generated randomisation schedule in a random-sized permuted blocks of four or six patients stratified by location of reconstruction (maxilla/mandible) and gender (F/M) to ensure that the numbers of participants receiving the two interventions are closely balanced within each stratum. The allocation numbers will be concealed in opaque sealed envelopes prepared by a central study coordinator, only opening them after informed consent and baseline measures have been obtained.

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 19, 2020
• Study Start: December 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)