Surgery Clinical Trial
— JaW PrinTOfficial title:
Jaw Reconstruction With Printed Titanium and Free Tissue Transfer
NCT number | NCT03905005 |
Other study ID # | 241919 |
Secondary ID | 38098 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 12, 2018 |
Est. completion date | September 2020 |
JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Morriston Hospital | Swansea |
Lead Sponsor | Collaborator |
---|---|
University of South Wales |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Duration of surgery | The impact of surgical technique (pathway A or B) on the duration of insetting the bony flap into the mandibular continuity defect. | 1 day (day of surgery) | |
Secondary | Operator's rating of usability/confidence/satisfaction with technique | Using 5 point Likert scale ratings of ease of flap preparation, ease of locating the reconstruction plate on the fibula, confidence with technique, ease of mandibular reconstruction, ease of locating the reconstruction plate on the mandible, bony apposition of fibula-fibula and fibula-mandible osteotomies as planned, satisfaction with morphology of reconstructed mandible, confidence with technique overall (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree). | 1 day (day of surgery) | |
Secondary | Need to make adjustments to reconstructive surgical plan intraoperatively | List of all required adjustments to the planned reconstructive surgical procedure (e.g. trimming of osteotomies etc.) are recorded. | 1 day (day of surgery) | |
Secondary | Complications | Incidence of intra/peri/post-operative complications are recorded (e.g. infection, plate exposure, prolonged hospital stay, non-union etc.) | 1 year postoperatively | |
Secondary | Qualitative evaluation of dental occlusal relationship and feasibility of dental implant rehabilitation | Qualitative Evaluation of changes in dental occlusion by evaluating dental plaster of Paris models (presence or absence of "malocclusion" pre and post-operatively) PLUS assessment/rating of feasibility of dental implant rehabilitation in relation to actual bony reconstruction using a 5 point likert scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) | 1 year postoperatively | |
Secondary | Patient reported quality of life relating to appearance | Subjective scoring of patient's own perceptions of their quality of life relating to their appearance using the Derriford Appearance Scale | Baseline, 6 weeks, 6 months, 1 year postoperatively | |
Secondary | Patient perceived quality of life relating to mood | University of Washington v4.0 questionnaire score. | Baseline, 6 weeks, 6 months, 1 year postoperatively | |
Secondary | Financial implications of surgical technique | Evaluation of cost differences (if any) between patient groups | Separately for duration of inpatient hospital stay (typically 2 weeks) and for the total 1 year study follow-up period (from identification of participant to completion of patient's participation). | |
Secondary | Patient perceived quality of life relating to oral function | Liverpool oral rehabilitation questionnaire scores. | Baseline, 6 weeks, 6 months, 1 year postoperatively | |
Secondary | objective quantitative evaluation of facial symmetry | stereophotogrammetry to assess facial symmetry. | Baseline, 6 weeks, 6 months, 1 year postoperatively |
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