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出境医 / 临床实验 / CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap
CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap
Study Description
Brief Summary:
A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups.
| Condition or disease | Intervention/treatment |
|---|---|
| Operation Time Complication of Surgical Procedure | Procedure: Computer-assisted surgery |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 153 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Computer-assisted Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap: A Matched-pair Study |
| Actual Study Start Date : | December 1, 2020 |
| Actual Primary Completion Date : | March 1, 2021 |
| Actual Study Completion Date : | April 18, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| Computer-assisted surgery (CAS) group |
Procedure: Computer-assisted surgery
Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.
|
| Non-CAS group |
Outcome Measures
Primary Outcome Measures :
- operation time [ Time Frame: within the surgery ]operation time
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019.
Criteria
Inclusion Criteria:
- Clinical diagnosis of head and neck cancer
- Received mandibular reconstruction
- All patients were followed up postoperatively for at least one year
Exclusion Criteria:
- Patients received bone graft for jaw reconstruction before mandibular reconstruction
Contacts and Locations
Locations
| Belgium | |
| UZ Leuven | |
| Leuven, Belgium | |
Sponsors and Collaborators
KU Leuven
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 7, 2021 | ||||
| First Posted Date | July 16, 2021 | ||||
| Last Update Posted Date | July 21, 2021 | ||||
| Actual Study Start Date | December 1, 2020 | ||||
| Actual Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
operation time [ Time Frame: within the surgery ] operation time
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap | ||||
| Official Title | Computer-assisted Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap: A Matched-pair Study | ||||
| Brief Summary | A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. The mandibular resection and reconstruction were performed by four experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic, osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up postoperatively for at least one year. Eighteen pairs were formed with the matched cohort consisting of a total of 36 patients who underwent primary mandibular reconstruction without additional combined flaps. The surgery-related and patient-related continuous and categorical parameters were assessed in both groups. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan 1999 to Dec 2019. | ||||
| Condition |
|
||||
| Intervention | Procedure: Computer-assisted surgery
Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
153 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | April 18, 2021 | ||||
| Actual Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Belgium | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04965441 | ||||
| Other Study ID Numbers | S63615-2 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Hongyang Ma, KU Leuven | ||||
| Study Sponsor | KU Leuven | ||||
| Collaborators | Not Provided | ||||
| Investigators | Not Provided | ||||
| PRS Account | KU Leuven | ||||
| Verification Date | July 2021 | ||||