Traumatic Amputation of Lower ExtremityProFitNCT02540681
Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma
An observational study of Traumatic Amputation of Lower Extremity, run by Major Extremity Trauma Research Consortium at 10 sites in United States.
Trial summary
The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is investigating prosthesis fit, alignment and condition of the residual limb. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Amputation of Lower Extremity
- How many people
- 33 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2015to Jan 2021
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be drawn from the TAOS study which enrolls patients with below the knee amputations from trauma centers participating in the Major Extremity Research Consortium (METRC).
Who may be able to join
- Must be enrolled in the TAOS study
Who cannot join
- Patients weighing <300 lbs.
- Patient requires an LAR
- Women who are breastfeeding or pregnant
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 20742
Carolinas Medical Center
Charlotte, North Carolina, 28204
MetroHealth Medical Center
Cleveland, Ohio, 44109
The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 78229
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Vanderbilt University
Nashville, Tennessee, 37232
San Antonio Military Medical Center
San Antonio, Texas, 78234
University of California at San Francisco
San Francisco, California, 94110
Tampa General Hospital
Tampa, Florida, 33606
Wake Forest University Baptist Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma (ProFit)
The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is investigating prosthesis fit, alignment and condition of the residual limb. As there are no validated measures of fit and alignment (factors known to impact comfort, function and performance among amputees) the TAOS study includes a provision in the protocol for acquisition of photographs, video and radiographs in order to help develop uniform assessments of the residual limb. The goal of the ProFit study is to validate and refine the prosthetic assessment tool (ProFit) that was developed by an expert panel of certified orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a measurement scientist and a biomedical engineer from the BADER consortium.
Read the detailed description
Specific Aim 1: To test the reliability of the ProFit.
Patients enrolled in the TAOS trial returning for their eighteen month final visit will undergo radiographic, video, and photographic assessment. A blinded prosthetist panel (PP) will view these remotely and complete a 42 item assessment based on x-ray, photo and video. We will examine two aspects of reliability for the ProFit, inter-rater reliability and internal consistency.
Specific Aim 2: To examine the validity and responsiveness of the ProFit.
This study aims to examine the validity of the ProFit by specifically evaluating factor validity, construct validity and discriminant validity. This will be accomplished by correlating ProFit scores with measures of self-reported pain (Brief Pain Inventory), function (Short Musculoskeletal Functional Assessment), and satisfaction (Orthotics and Prosthetics User's Survey). Moreover, a subset of subjects will undergo quantitative measurement of fit and alignment using a novel prosthesis-mounted socket reaction moment sensor. Responsiveness of the ProFit will be based on repeated measurements at 6 and 18 months.
Specific Aim 3: To develop a shorter version of the ProFit.
Based on findings from Aim 1 and 2 at the individual item level, we will remove items that: 1) have poor inter-rater agreement; 2) demonstrate weak relationships with clinician and patient report of overall fit; or 3) exhibit strong ceiling or floor effects.
Study design: The ProFit study is a prospective validation study of an assessment of prosthetic fit and alignment among patients with a transtibial amputation.
Study duration: 3 years Sample size: 120 TAOS patients will provide adequate power to detect important differences in fit and alignment 18 months following amputation. A subset of 60 patients is necessary to detect significant differences in alignment using the Smart Pyramid.
Number of study sites: Up to 35 centers including 24 Core METRC sites, 4 MTFs, and 7 METRC satellite sites.
Study population: Patients enrolled in the METRC TAOS study.
Outcome measure: This ancillary project to the TAOS trial is designed to study the validity reliability and validity of the ProFit, a 42-item tool for assessing prosthetic fit and alignment among patients with a transtibial amputation.
Statistical analysis: Inter-rater reliability and internal consistency will be examined to test the reliability of the ProFit. The validity of this assessment will be evaluated using a variety of construct validity tests. Based on findings from the reliability and validity analysis, a shorter version of the ProFit will be developed. The performance of the shorter version will be determined based on correlation with the original assessment.
Randomization: Not applicable
Safety monitoring: Not applicable
- Conditions
- Traumatic Amputation of Lower Extremity
- Keywords
- Transtibial amputation, Prosthetic fit, Prosthetic alignment
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Fit and Alignment
A panel of CPOs will evaluate prosthetic fit and alignment using a 42 item assessment tool.
Measured: 18 months
Secondary outcomes (3)
Reliability of ProFit assessment tool
Measured: 18 months
Validity of ProFit Assessment tool
Measured: 18 months
Responsiveness of ProFit Assessment tool
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2021
- Study completionJan 2021
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 Traumatic Amputation of Lower ExtremityStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Lisa Reider, PhD, Study director, Major Extremity Trauma Research Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540681
- Sponsor's protocol ID
- OR130357
- Acronym
- ProFit
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2015
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Major Extremity Trauma Research Consortium (METRC). Development of a prosthetic fit and alignment assessment (ProFit) in persons with post-traumatic transtibial amputation. Prosthet Orthot Int. 2023 Dec 1;47(6):599-606. doi: 10.1097/PXR.0000000000000237. Epub 2023 Apr 4.
PubMed 37052578
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Fit Assessment in Transtibial Amputees Secondary to Trauma (ProFit)
- ClinicalTrials.gov ID
- NCT02540681
- Acronym / sponsor ID
- ProFit / OR130357
- Conditions
- Traumatic Amputation of Lower Extremity
- Keywords
- Transtibial amputation, Prosthetic fit, Prosthetic alignment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Jan 2015
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 4 Sep 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.
The aims of this study address an exploratory endpoint in the Major Extremity Trauma Research Consortium (METRC) Transtibial Amputation Outcomes Study (TAOS; NCT01821976) that is investigating prosthesis fit, alignment and condition of the residual limb. As there are no validated measures of fit and alignment (factors known to impact comfort, function and performance among amputees) the TAOS study includes a provision in the protocol for acquisition of photographs, video and radiographs in order to help develop uniform assessments of the residual limb. The goal of the ProFit study is to validate and refine the prosthetic assessment tool (ProFit) that was developed by an expert panel of certified orthotist prosthetistis (CPOs) in collaboration with orthopaedic trauma investigators, a measurement scientist and a biomedical engineer from the BADER consortium.
Detailed description
Specific Aim 1: To test the reliability of the ProFit.
Patients enrolled in the TAOS trial returning for their eighteen month final visit will undergo radiographic, video, and photographic assessment. A blinded prosthetist panel (PP) will view these remotely and complete a 42 item assessment based on x-ray, photo and video. We will examine two aspects of reliability for the ProFit, inter-rater reliability and internal consistency.
Specific Aim 2: To examine the validity and responsiveness of the ProFit.
This study aims to examine the validity of the ProFit by specifically evaluating factor validity, construct validity and discriminant validity. This will be accomplished by correlating ProFit scores with measures of self-reported pain (Brief Pain Inventory), function (Short Musculoskeletal Functional Assessment), and satisfaction (Orthotics and Prosthetics User's Survey). Moreover, a subset of subjects will undergo quantitative measurement of fit and alignment using a novel prosthesis-mounted socket reaction moment sensor. Responsiveness of the ProFit will be based on repeated measurements at 6 and 18 months.
Specific Aim 3: To develop a shorter version of the ProFit.
Based on findings from Aim 1 and 2 at the individual item level, we will remove items that: 1) have poor inter-rater agreement; 2) demonstrate weak relationships with clinician and patient report of overall fit; or 3) exhibit strong ceiling or floor effects.
Study design: The ProFit study is a prospective validation study of an assessment of prosthetic fit and alignment among patients with a transtibial amputation.
Study duration: 3 years Sample size: 120 TAOS patients will provide adequate power to detect important differences in fit and alignment 18 months following amputation. A subset of 60 patients is necessary to detect significant differences in alignment using the Smart Pyramid.
Number of study sites: Up to 35 centers including 24 Core METRC sites, 4 MTFs, and 7 METRC satellite sites.
Study population: Patients enrolled in the METRC TAOS study.
Outcome measure: This ancillary project to the TAOS trial is designed to study the validity reliability and validity of the ProFit, a 42-item tool for assessing prosthetic fit and alignment among patients with a transtibial amputation.
Statistical analysis: Inter-rater reliability and internal consistency will be examined to test the reliability of the ProFit. The validity of this assessment will be evaluated using a variety of construct validity tests. Based on findings from the reliability and validity analysis, a shorter version of the ProFit will be developed. The performance of the shorter version will be determined based on correlation with the original assessment.
Randomization: Not applicable
Safety monitoring: Not applicable
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be drawn from the TAOS study which enrolls patients with below the knee amputations from trauma centers participating in the Major Extremity Research Consortium (METRC).
Key inclusion criteria (1 listed)
- Must be enrolled in the TAOS study
Key exclusion criteria (3 listed)
- Patients weighing <300 lbs.
- Patient requires an LAR
- Women who are breastfeeding or pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prosthetic Fit and Alignment
Time frame: 18 months
A panel of CPOs will evaluate prosthetic fit and alignment using a 42 item assessment tool.
3 secondary outcomes
Reliability of ProFit assessment tool
Time frame: 18 months
Validity of ProFit Assessment tool
Time frame: 18 months
Responsiveness of ProFit Assessment tool
Time frame: 18 months
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 24 Mar 2021.
- Derived from this study: PubMed 37052578Major Extremity Trauma Research Consortium (METRC). Development of a prosthetic fit and alignment assessment (ProFit) in persons with post-traumatic transtibial amputation. Prosthet Orthot Int. 2023 Dec 1;47(6):599-606. doi: 10.1097/PXR.0000000000000237. Epub 2023 Apr 4.
Related trials for Traumatic Amputation of Lower Extremity
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
REsistance and LOADing Exercise for Bone Health
Amputation of Lower Limb Below Knee, Amputation, Traumatic
Recruiting
Dual-Task Balance Training in Traumatic Lower-Limb Prosthesis Users
Lower Limb Amputation, Prosthesis Users
Active, not recruitingObservational study
Kinematics of Ewing Amputees
Lower Extremity Amputation, Trans-Tibial Amputation
Recruiting
Optimizing Gait Rehabilitation for Veterans With Non-traumatic Lower Limb Amputation
Transtibial Amputation, Peripheral Artery Disease
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.
Lisa Reider, PhD study director
Major Extremity Trauma Research Consortium
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Amputation of Lower Extremity, run by Major Extremity Trauma Research Consortium at 10 sites 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 1 inclusion and 3 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Prosthetic Fit and Alignment (time frame: 18 months). 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 NCT02540681, 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 24 Mar 2021.