Clinical Trial: Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Outcomes Following Severe Distal Tibia, Ankle and/or Foot Trauma: Comparison of Limb Salvage Versus Transtibial Amputation Protocol (OUTLET Study)

Brief 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 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).


Detailed Summary:
Sponsor: Major Extremity Trauma Research Consortium

Current 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Physical impairment [ Time Frame: 18 months ]
    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.
  • Levels of participation [ Time Frame: 18 months ]
    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.


Original Secondary Outcome:

  • Physical impairment [ Time Frame: 18 months ]
    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.
  • Levels of participation [ Time Frame: 18 months ]
    Levels of participation will be measured using self reported measures of return to usual major activty (work, active duty, school, home management) and the Paffenbarger Activty Scale (PPAQ) that measures participation in light, moderate and vigorous recreational or sports activities.


Information By: Major Extremity Trauma Research Consortium

Dates:
Date Received: April 16, 2012
Date Started: May 2012
Date Completion: March 2018
Last Updated: April 25, 2017
Last Verified: March 2016