Jaw Reconstruction With Printed Titanium and Free Tissue Transfer

NCT ID: NCT03905005

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2021-10-01

Brief Summary

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

Detailed Description

JaW PrinT is a 'real-world' prospective observational pilot study, evaluating the clinical effectiveness, usability and economics of two approaches to mandibular reconstruction surgery (using flexed titanium versus printed titanium patient-specific osseosynthesis plates). Patient participants will be recruited prospectively over a minimum period of 18 months (with observation of at least 10 participants in each treatment pathway). The figures are based upon the historical clinical practice of the research site, with both techniques in equal use; choice depending on resources, surgical training requirements and surgeon's clinical preference.

As a purely observational study, treatment choice will be made in the normal clinical manner and will in no way be influenced by the study itself.

Participants will be followed up at their routine outpatient clinics (6 weeks, 6 months and 1 year postoperatively) with prospective outcomes data collection.

Participants will be recruited prospectively as they present as new patient cases to the Maxillofacial and Head & Neck cancer multidisciplinary team (MDT) clinics. Once a potential patient participant has been given his/her diagnosis and it is confirmed by the principal investigator (PI) that he/she meets the inclusion criteria, clinic staff will provide the potential participant with an invitation letter introducing the study as well as a patient information sheet and consent form (explaining the available options of participating or refraining from the study). Patients will be allowed up to 24 hours to decide whether or not to participate as to avoid any impact/delay on the scheduling of their clinical treatment. The PI will obtain written informed consent from willing participants.

Upon recruitment, provision of informed consent and collection of baseline data, as per standard clinical practice, the patient participant's CT scan data is used to produce a virtual surgical plan for the mandibular resection and fibular free-flap reconstruction. Once the clinically optimal reconstructive surgical plan is established by the surgeon and technician, the choice of surgical approach will be made in the routine clinical manner by the surgeon: Pathway A (pre-flexed customized mandibular reconstruction plate and cutting guides) or to pathway B (SLM customized mandibular reconstruction plate and cutting guides). Both treatment pathways are already part of routine/standard clinical practice at the research site.

The expected/planned patient numbers for this study are based upon the historical workload of the department, typically at 10-20 cases annually. A recruitment period of 18 months with follow-up for 1 year fits within the time constraints of the postgraduate student investigator's PhD timeline.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Mandibular reconstruction with free tissue transfer.

Intervention Type: 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).

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.

Mandibular reconstruction with free tissue transfer.

Intervention Type: 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).

Interventions

Mandibular reconstruction with free tissue transfer.

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).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Wales

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M Williams, PhD

Role: STUDY_CHAIR

University of South Wales

A Goodson, MBBS

Role: STUDY_DIRECTOR

University of South Wales

M Kittur, MBBS

Role: PRINCIPAL_INVESTIGATOR

Morriston Hospital, ABMU Health Board

Locations

Morriston Hospital

Swansea, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

38098

Identifier Type: OTHER

Identifier Source: secondary_id

241919

Identifier Type: -

Identifier Source: org_study_id