Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: physical exam; Behavioral: questionnaires

• Registration Number: NCT02572869
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-30
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Status Verified: 2019-08
• Primary Completion: 2019-08-16
• Study Completion: 2019-08-16
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Able to read and write in the English language
• Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
• Able to travel to the MSK outpatient clinic or have access to email, the MSK patient portal and a computer with a camera for the follow up examination by a physician and completion of the questionnaires.

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Exclusion Criteria

• Patients who underwent marginal mandibulectomy
• Patients who underwent mandibular reconstruction with a different type of vascularized bone free flap
• Patients who underwent mandibular reconstruction with soft tissue free flap

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
segmental mandibulectomy and free fibular flap reconstruction	questionnaires	Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
segmental mandibulectomy and free fibular flap reconstruction	physical exam	Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014

Primary Outcome Measures

Name	Time	Method
Long-term aesthetic outcome evaluated by photographs	1 year	archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.
Long-term functional (11-item clinical examination form which documents the patient's oral function)	1 year	The examining physician will then complete an 11-item clinical examination form which documents the patient's oral function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech,drooling, diet, appearance, oral sensation, and shoulder movement.

Trial Locations

Locations (3)

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States