NCT05715359

Brief Summary

The aim of the present project is to evaluate the outcome from reconstruction of the jaws, with a standardized simplified technique, after a continuous defect. The primary objective is to measure recurrence of the tumour is present as a marking for insufficient resection margins. Secondary objectives are measures of survival of transplanted tissues, registered complications at follow-up and measures of healing between segments of transplanted bone (bone bridging).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Oct 2023Dec 2027

First Submitted

Initial submission to the registry

January 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

3.2 years

First QC Date

January 27, 2023

Last Update Submit

April 9, 2024

Conditions

Oral Surgical ProceduresSurgery, OralMandibular Reconstruction

Keywords

MaxillofacialReconstructionOsteotomyMaxillaMandible

Outcome Measures

Primary Outcomes (1)

  • Reccurence of tumour.

    Reccurent tumour meaning not radical resection margins

    At least one year follow-up after resection.

Secondary Outcomes (2)

  • Tissue transfer survival

    At least one year follow-up after resection.

  • Oral function

    At least one year follow-up after resection.

Study Arms (1)

Reconstruction of jaws.

Patients treated with free tissue transfer reconstruction of the jaws.

Procedure: Reconstruction

Interventions

ReconstructionPROCEDURE

Standardized template for reconstruction of continious defects of the jaws.

Reconstruction of jaws.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients treated at Skåne University Hospital, Lund, Sweden between 2002-2021 with reconstruction of the jaws using a standardized osteotomy guide.

You may qualify if:

  • Treated at Skåne University Hospital, Lund, Sweden between 2002-2021 with reconstruction of the jaws using a standardized osteotomy guide.

You may not qualify if:

  • Less than one year follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Oral and Maxillofacial Surgery

Lund, 22185, Sweden

Location

MeSH Terms

Interventions

Plastic Surgery Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Martin Bengtsson, DDS, PhD

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, PhD, Consultant Oral and Maxillofacial Surgeon

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 8, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)