Severe Distal Tibia InjuryOUTLETNCT01606501
Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol
An observational study of Severe Distal Tibia Injury and Severe Ankle Injury, run by Major Extremity Trauma Research Consortium at 33 sites in United States.
Trial summary
The primary aim this prospective longitudinal observational outcomes study is to compare 18 month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot fractures with major soft tissue, bone and/or ankle… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Distal Tibia Injury, Severe Ankle Injury, Severe Foot Injury
- How many people
- 664 participants
- Where
- 33 sitesUnited States
- Study dates
- May 2012to 20 Sep 2019
- 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: The study population will be patients aged 18-60 with severe open or crushed distal tibia, ankle and/or foot injury that go on to limb salvage or receive a below the knee amputation.
Who may be able to join
- Patients with an injury that meets at least one of the following:
- Gustilo type III pilon fractures consistent with one of the following OTA codes: 43B1.3, 43B2-B3, 43C, 44B, 44C
- Gustilo type III B or C ankle fractures
- Gustilo type III mid and/or hind foot fractures consistent with one of the following OTA codes: 81B2-B3, 82B and 82C
- Open foot crush or blast injuries from high energy mechanism involving the mid and /or hind foot with significant soft tissues damage
- Other severe foot injury (including closed foot crush or blast injuries)
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- Ages 18-60 inclusive.
- Admitted to the hospital prior to definitive wound closure.
- Patients may have other injuries except as noted below under exclusion criteria.
- Foot crush and blast injuries are eligible if they are considered to be at significant risk for impaired outcome with moderate to severe disability and typically include one of the following associated injuries:
- ankle dislocation (80A)
- subtalar dislocation (80B)
- extruded talus
- chopart dislocation (80C)
- multiple midfoot dislocations (80C)
- three or greater proximal metatarsal fractures
- heel pad/plantar degloving
- extensive muscle necrosis in an open injury from crush, ischemia and/or foot compartment syndrome
- These injuries may include "toe-pan" injuries from motor vehicle accidents and crush-like injuries from motorcycle accidents, and traumatic amputations.
Who cannot join
- Patient has a Glasgow Coma Scale motor score of 0-4 or a Glasgow Coma Scale motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6) at time of consent
- Patient has third degree burns on >10% total surface area affecting the study limb
- Patient has a previous leg or foot amputation of either limb
- Patient is non-ambulatory due to an associated complete spinal cord injury
- Patient non-ambulatory pre-injury
- Patient speaks neither English nor Spanish
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- Patient likely to have severe problems with maintaining follow- up due to at least one of the following:
- Patient has been diagnosed with a severe psychiatric condition
- Patient is intellectually challenged without adequate family support
- Patient lives outside the hospital's catchment area
- Follow-up is planned at another medical center
- Patients who are prisoners or homeless
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
University of Maryland Medical Center
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Virginia
Charlottesville, Virginia, 22908
MetroHealth
Cleveland, Ohio, 44109
Denver Health and Hospital Authority
Denver, Colorado, 80204
Duke University Medical Center
Durham, North Carolina, 27710
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49525
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Eskenazi Health
Indianapolis, Indiana, 46202
OrthoIndy Methodist Hospital
Indianapolis, Indiana, 46202
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260
University of Iowa Medical Center
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Jamaica Hospital Medical Center
Jamaica, New York, 11418
University of Miami Ryder Trauma Center
Miami, Florida, 33136
Hennepin County Medical Center
Minneapolis, Minnesota, 55430
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Orlando Regional Medical Center
Orlando, Florida, 32806
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rhode Island/ Brown University
Providence, Rhode Island, 02905
San Antonio Military Medical Center
San Antonio, Texas, 78434
Navy Medical Center San Diego
San Diego, California, 92134
University of California San Francisco Medical Center
San Francisco, California, 94143
University of Washington/Harborview Medical Center
Seattle, Washington, 98104
Barnes Jewish Hospital
St Louis, Missouri, 63110
St. Louis University Medical Center
St Louis, Missouri, 63110
Florida Orthopaedic Institute, St. Joseph's Hospital
Tampa, Florida, 33606
Florida Orthopaedic Institute, Tampa General Hospital
Tampa, Florida, 33606
Walter Reed National Military Medical Center
Washington D.C., District of Columbia, 20307
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
The primary aim this prospective longitudinal observational outcomes study is to compare 18 month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot fractures with major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL will be measured using well established self reported measures, including the Veterans Rand Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).
Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss will have similar functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
- Conditions
- Severe Distal Tibia Injury, Severe Ankle Injury, Severe Foot Injury, Major Soft Tissue Loss, Major Bone Articular Surface Loss, Major Ankle Articular Surface Loss
- Medical subject headings
- Ankle Injuries, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Limb Salvage patients | Patients undergoing limb salvage following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss. | |
| Transtibial Amputation patients | Patients undergoing transtibial amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported function and health related quality of life
Functional Outcomes and health related quality of life will be measured using well established self reported measures, including the Veterans RAND Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).
Measured: 18 months
Secondary outcomes (2)
Physical impairment
Physical impairment will be determined using objective performance measures of agility (4 step square test and Illinois Agility Test), strength and power (sit-to-stand test and timed stair climb), speed (self-selected walking speed and 40 yard shuttle run), postural stability (single leg stance) and overall activity will be measured using the step watch activity monitor.
Measured: 18 months
Levels of participation
Levels of participation will be measured using self reported measures of return to usual major activity (work, active duty, school, home management) and the Paffenbarger Activity Scale (PPAQ) that measures participation in light, moderate and vigorous recreational or sports activities.
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 posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
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 Severe Distal Tibia InjuryStudies 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
- 664 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Bosse, MD, Principal investigator, Carolinas Medical CenterLisa Reider, MHS, PhD, Study director, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606501
- Sponsor's protocol ID
- W81XWH-09-2-0108-OUT
- Acronym
- OUTLET
- Status last verified
- Mar 2021
- First submitted
- 16 Apr 2012
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McLaughlin KH, Mitchell SL, Archer KR, Master H, Morshed S, Gary JL, Jones CB, MacKenzie EJ, Reider L; METRC. Effect of Severe Distal Tibia, Ankle, and Mid- to Hindfoot Trauma on Meeting Physical Activity Guidelines 18 Months After Injury. Arch Phys Med Rehabil. 2022 Mar;103(3):409-417.e2. doi: 10.1016/j.apmr.2021.07.805. Epub 2021 Aug 21.
PubMed 34425087
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
- Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)
- ClinicalTrials.gov ID
- NCT01606501
- Acronym / sponsor ID
- OUTLET / W81XWH-09-2-0108-OUT
- Conditions
- Severe Distal Tibia Injury, Severe Ankle Injury, Severe Foot Injury, Major Soft Tissue Loss, Major Bone Articular Surface Loss, Major Ankle Articular Surface Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 664 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 25 May 2012 (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 primary aim this prospective longitudinal observational outcomes study is to compare 18 month functional outcomes and health related quality of life (HRQoL) of patients undergoing salvage versus amputation following severe distal tibia, ankle and/or foot fractures with major soft tissue, bone and/or ankle articular surface loss. Functional outcomes and HRQoL will be measured using well established self reported measures, including the Veterans Rand Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).
Hypothesis 1: As a group, salvage patients with severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss will have similar functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
Hypothesis 2: The subgroup of salvage patients who have either (1) a soft tissue injury that requires tissue transfer; (2) articular damage requiring arthrodesis of the ankle joint; or (3) bone loss at the distal tibia or ankle will have better functional outcomes and HRQoL had they undergone a transtibial amputation (within 6 weeks of injury).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limb Salvage patients | – | –Patients undergoing limb salvage following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss. |
| Transtibial Amputation patients | – | –Patients undergoing transtibial amputation following severe distal tibia, ankle and/or foot injuries with major soft tissue, bone and/or ankle articular surface loss. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be patients aged 18-60 with severe open or crushed distal tibia, ankle and/or foot injury that go on to limb salvage or receive a below the knee amputation.
Key inclusion criteria (19 listed)
- Patients with an injury that meets at least one of the following:
- Ages 18-60 inclusive.
- Admitted to the hospital prior to definitive wound closure.
- Patients may have other injuries except as noted below under exclusion criteria.
- Foot crush and blast injuries are eligible if they are considered to be at significant risk for impaired outcome with moderate to severe disability and typically include one of the following associated injuries:
Key exclusion criteria (12 listed)
- Patient has a Glasgow Coma Scale motor score of 0-4 or a Glasgow Coma Scale motor score of 5 with a significant traumatic brain injury (defined as an AIS code of 5 or 6) at time of consent
- Patient has third degree burns on >10% total surface area affecting the study limb
- Patient has a previous leg or foot amputation of either limb
- Patient is non-ambulatory due to an associated complete spinal cord injury
- Patient non-ambulatory pre-injury
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
Patient reported function and health related quality of life
Time frame: 18 months
Functional Outcomes and health related quality of life will be measured using well established self reported measures, including the Veterans RAND Health Survey (VR-12) and the Short Musculoskeletal Functional Assessment (SMFA).
2 secondary outcomes
Physical impairment
Time frame: 18 months
Levels of participation
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 34425087McLaughlin KH, Mitchell SL, Archer KR, Master H, Morshed S, Gary JL, Jones CB, MacKenzie EJ, Reider L; METRC. Effect of Severe Distal Tibia, Ankle, and Mid- to Hindfoot Trauma on Meeting Physical Activity Guidelines 18 Months After Injury. Arch Phys Med Rehabil. 2022 Mar;103(3):409-417.e2. doi: 10.1016/j.apmr.2021.07.805. Epub 2021 Aug 21.
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.
Michael J Bosse, MD principal investigator
Carolinas Medical Center
Lisa Reider, MHS, PhD study director
Johns Hopkins Bloomberg School of Public Health
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Distal Tibia Injury and Severe Ankle Injury, run by Major Extremity Trauma Research Consortium at 33 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 19 inclusion and 12 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 33 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?
Patient reported function and health related quality of life (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 NCT01606501, 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.