Clinical trial NCT02332161: Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer
Official title: Does Harvesting an Anterolateral Thigh (ALT) Flap Impact Lower Extremity Function and Activities of Daily Living (ADL) in Patients Undergoing Reconstructive Surgery for Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Free Tissue Flaps
Head and Neck Neoplasms
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient over age 18 undergoing anterolateral thigh free tissue transfer for head and neck cancer reconstruction at the University of Chicago

Brief summary: Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and neck reconstruction after head and neck cancer removal. The procedure involves removing some muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of this study is to determine the impact of ALT on ambulation and activities of daily living (ADLs)

Detailed description: The ALT flap may be harvested as a subcutaneous, fasciocutaneous, musculocutaneous, or adipofascial flap. At our institution, three surgeons commonly use this method of free tissue transfer to reconstruct such defects. In our experience, patients following harvest of ALT flap have impairments in lower extremity function that result in decreased independence with transfers, gait and ability to independently perform ADLs. Consequently, these patients receive Physical and Occupational Therapy following surgery and a number of patients go on to receive therapy in a rehabilitation facility and/or as an outpatient. A number of studies have examined donor site morbidity and lower extremity function following ALT flap harvest. These studies, however, are heterogeneous and primarily use patient reported and non-standardized scales as outcome measures. Additionally, there is a paucity of literature related to Physical Therapy and Occupational Therapy outcomes and intervention with this patient population, despite frequent referral of these patients for post-surgical therapy.

This investigation will utilize the Lower Extremity Functional Scale, the Functional Independence Measure, dynamometry, video analysis of a single leg squat and walking speed in an effort to better assess the affect of ALT harvesting on patients' functional capacity post operatively. These tests are valid and reliable measures commonly utilized in Physical Rehabilitation.

Eligibility criteria: Inclusion Criteria:

1. Over age 18;
2. Head and neck cancer;
3. To undergo anterolateral thigh free tissue transfer for head and neck reconstruction

Exclusion Criteria:

1. Inability to ambulate independently prior to surgery;
2. Inability to negotiate stairs prior to surgery;
3. Inability to follow simple commands;
4. Inability to negotiate stairs prior to surgery;
5. Previous free flap harvest from either lower extremity

Primary outcomes:
measure: Lower Extremity Functional Scale
timeFrame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Secondary outcomes:
measure: Lower Extremity Function
timeFrame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
measure: Functional Independence Measure
timeFrame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
measure: Lower Extremity Strength
timeFrame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Alexander Langerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.