跳至主要内容
临床试验/NCT05715359
NCT05715359Enrolling By Invitation不适用

Standardized Osteotomy Guides for Free Flap Reconstruction of Continuous Defects of the Jaws - a Simplified Method

Lund University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Reccurence of tumour.

研究概览

简要总结

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).

详细描述

Subjects The participants in this retrospective survey were consecutive head- and neck malignancy patients referred 2002-2021 to Skåne University Hospital, Lund, Sweden with an osseous proximity or malignancy. The treatment consisted of combined surgical resection and radiotherapy. Patients will be identified through the use of ICD-coding. All patients included underwent a primary functional and aesthetical reconstruction of continuous defects of the jaws with free vascularized tissue transfer adopted to the area of resection with the aid of a standardized osteotomy guide. The subjects eligible for inclusion in this project should present at least 1-year postoperative follow-up.

Patients eligible for inclusion will be notified in newspaper announcement. One announcement in a national newspaper and one announcement in the member newspaper of the Association for oral and neck cancer patients. Patients that are not agreeing to take part in this project are expected to declare this to the primary investigator. A drop-out analysis will be performed on 30 of the not included subjects according to age and gender.

Surgical Method Reconstruction of resected osseous anatomy was performed on the same occasion as tumour resection. Increased resection margins were decided after marginal intraoperative frozen autopsies. The reconstruction was performed aiming for maximal function with the best possible aesthetic outcome. All patients were initially planned to finalize the reconstructive phase with a dental rehabilitation of dentition lost during the oncological treatment. When applicable, a full dental rehabilitation was performed at least 12 months after resection.

Surgically, a non-customized template with dimensions taken from The Brånemark Novum® concept was used. Hence, the in-house template and cutting guide design was based upon a mean dimension of the size and form in a fully-grown individual. A sectioning of the transplant into three pieces, one frontal and two lateral, for reconstruction of the mandibular body was used as the base for the design. The angle between the segments was designed into aslant of thirty degrees.

The template and cutting guide were initially designed for mandibular reconstruction with an osseo-musculo-cuttaneous vascularized fibula graft. With time, the design was also suitable and used for reconstruction of maxillary and midface reconstruction and in cases with other flaps, like the tip and lateral rim of scapula.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Less than one year follow-up.

结局指标

主要结局

Reccurence of tumour.

时间窗: At least one year follow-up after resection.

Reccurent tumour meaning not radical resection margins

次要结局

  • Oral function(At least one year follow-up after resection.)
  • Tissue transfer survival(At least one year follow-up after resection.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Bengtsson

DDS, PhD, Consultant Oral and Maxillofacial Surgeon

Lund University Hospital

研究点 (1)

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