Trials / Completed

CompletedNCT01606501

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

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 664 (actual)

Sponsor: Major Extremity Trauma Research Consortium · Academic / Other
Sex: All
Age: 18 Years – 60 Years
Healthy volunteers: Not accepted

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).

Conditions

Timeline

Start date: 2012-05-01
Primary completion: 2019-09-20
Completion: 2019-09-20
First posted: 2012-05-25
Last updated: 2021-03-24

Locations

33 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01606501. Inclusion in this directory is not an endorsement.