Jaw Reconstruction With Printed Titanium and Free Tissue Transfer

NCT03905005 | Completed

• 2 other identifiers: 24191938098
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.

Conditions

Neoplasm, Oral; Osteoradionecrosis of Jaw; Mandibular Diseases; Jaw Cancer; Jaw Diseases; Surgery

Outcome Measures

Primary Outcomes (1)

• Dimensional accuracy

  Dimensional accuracy of the bony reconstruction, as demonstrated by comparing 6 months postoperative CT scan DICOM data with a presurgical digital surgical plan.

  6 months

Secondary Outcomes (10)

• Duration of surgery

  1 day (day of surgery)

• Operator's rating of usability/confidence/satisfaction with technique

  1 day (day of surgery)

• Need to make adjustments to reconstructive surgical plan intraoperatively

  1 day (day of surgery)

• Complications

  1 year postoperatively

• Qualitative evaluation of dental occlusal relationship and feasibility of dental implant rehabilitation

  1 year postoperatively

Study Arms (2)

Pre-flexed reconstruction plate

Patients who undergo mandibular reconstruction using a pre-flexed osseosynthesis reconstruction plate along with free-tissue transfer for reconstruction of a mandibular continuity defect.

Procedure: Mandibular reconstruction with free tissue transfer.

Printed reconstruction plate

Patients who undergo mandibular reconstruction using a 3D-printed reconstruction plate made by selective laser melting (SLM), along with free-tissue transfer for reconstruction of a mandibular continuity defect.

Procedure: Mandibular reconstruction with free tissue transfer.

Interventions

Mandibular reconstruction with free tissue transfer. PROCEDURE

Mandibular reconstruction with free tissue transfer (free-flap bony reconstruction) requires the use of a titanium plate to secure bony segments until bony healing is complete. Plates are made of titanium but can be customised to the anatomical shape of the mandible by two different techniques: flexing (bending) of the plate before surgery, or printing of the plate from titanium alloy powder bed fusion techniques (additive manufacturing, such as selective laser melting).

Pre-flexed reconstruction plate; Printed reconstruction plate

Eligibility Criteria

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

Study Population

Patients from the study site region requiring free-flap reconstruction of the mandible (e.g. for tumour or osteoradionecrosis):

You may qualify if:

• Age over 18 years
• Able to provide informed consent
• A planned fibular free-flap reconstruction of the mandible
• Planned post operative surveillance CT scan 6 months following surgery

You may not qualify if:

• Clinically unfit or inappropriate (based upon prognosis/life expectancy) for reconstruction using free tissue transfer techniques
• Patients with planned surgical defects involving formal reconstruction of the condyle. (Clinical use of printed plates for condylar reconstructions would in effect be 'off-licence' and non-standard treatment which is beyond the remit of an observational research study).
• Flap failure within the study follow-up period, as this would require early removal of the flap and therefore preclude collection of follow-up outcome data. However, any flap failures (and associated clinical complications/events) will be recorded and reported.

Sponsors & Collaborators

• University of South Wales: lead

Study Sites (1)

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

MeSH Terms

Conditions

Mouth Neoplasms; Mandibular Diseases; Jaw Neoplasms; Jaw Diseases

Interventions

Mandibular Reconstruction

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Musculoskeletal Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry

Study Officials

• M Williams, PhD

  University of South Wales

  STUDY CHAIR

• A Goodson, MBBS

  University of South Wales

  STUDY DIRECTOR

• M Kittur, MBBS

  Morriston Hospital, ABMU Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 5, 2019
• Study Start: March 12, 2018
• Primary Completion: April 1, 2021
• Study Completion: October 1, 2021
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

GB (1)