Free Tissue FlapsNCT02332161
Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer
An observational study of Free Tissue Flaps and Head and Neck Neoplasms, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Free Tissue Flaps, Head and Neck Neoplasms
- What is being tested?
- surveys, evaluative tests for leg function
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to 26 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient over age 18 undergoing anterolateral thigh free tissue transfer for head and neck cancer reconstruction at the University of Chicago
Who may be able to join
- Over age 18;
- Head and neck cancer;
- To undergo anterolateral thigh free tissue transfer for head and neck reconstruction
Who cannot join
- Inability to ambulate independently prior to surgery;
- Inability to negotiate stairs prior to surgery;
- Inability to follow simple commands;
- Inability to negotiate stairs prior to surgery;
- Previous free flap harvest from either lower extremity
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Conditions
- Free Tissue Flaps, Head and Neck Neoplasms
- Being tested
- surveys, evaluative tests for leg function
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveys, evaluative tests for leg functionOther
See outcome measures
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Functional Scale
The Lower Extremity Functional Scale (LEFS) is a validated self-report measure designed to assess the functional capabilities of patients with any lower extremity related musculoskeletal condition. Subjects will be assessed for a change from pre- to post-operative
Measured: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Secondary outcomes (3)
Lower Extremity Function
Standing on one leg and walking, specifically duration of standing on one leg in minutes and distance walked up to 100 ft. Subjects will be assessed from pre-to-postoperative to determine the decline in leg function.
Measured: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Functional Independence Measure
The Functional Independence Measure (FIM) will assess subject ability to perform activities of daily living such as bathing, lower body dressing, toileting, bed to chair transfer, toilet transfer, walking on level and stairs, social interaction, problem solving and memory. We will assess the change from pre- to post-operative
Measured: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Lower Extremity Strength
Dynamometry will be performed in seated position to determine a change in muscle strength from pre- to post-operative
Measured: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2014
- Primary completion26 Jun 2017
- Study completion26 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Free Tissue FlapsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Langerman, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332161
- Sponsor's protocol ID
- 13-1375
- Status last verified
- Apr 2023
- First submitted
- 30 Dec 2014
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10201543
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02332161
- Acronym / sponsor ID
- 13-1375
- Conditions
- Free Tissue Flaps, Head and Neck Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 26 Jun 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient over age 18 undergoing anterolateral thigh free tissue transfer for head and neck cancer reconstruction at the University of Chicago
Key inclusion criteria (3 listed)
- Over age 18;
- Head and neck cancer;
- To undergo anterolateral thigh free tissue transfer for head and neck reconstruction
Key exclusion criteria (5 listed)
- Inability to ambulate independently prior to surgery;
- Inability to negotiate stairs prior to surgery;
- Inability to follow simple commands;
- Inability to negotiate stairs prior to surgery;
- Previous free flap harvest from either lower extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveys, evaluative tests for leg functionSee outcome measures | Other | – |
Primary outcome
Lower Extremity Functional Scale
Time frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
The Lower Extremity Functional Scale (LEFS) is a validated self-report measure designed to assess the functional capabilities of patients with any lower extremity related musculoskeletal condition. Subjects will be assessed for a change from pre- to post-operative
3 secondary outcomes
Lower Extremity Function
Time frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Functional Independence Measure
Time frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Lower Extremity Strength
Time frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Background: PubMed 10201543Binkley 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.
Related trials for Free Tissue Flaps
RecruitingPhase 1
ESP Blocks in Breast Free Flaps
Breast Reconstruction, Free Flap Reconstruction
Not yet recruitingObservational study
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
Reconstructive Surgery, Flap Monitoring
Recruiting
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm
RecruitingPhase 4
Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)
Head and Neck Cancer (H&N), Free Tissue Flaps
Not yet recruiting
Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation
Keratinized Mucosa Deficiency, Peri-implant Soft Tissue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Langerman, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Free Tissue Flaps and Head and Neck Neoplasms, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Extremity Functional Scale (time frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02332161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.