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

NCT01606501 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 664

Last updated 2021-03-24

No results posted yet for this study

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

  • Severe Distal Tibia Injury
  • Severe Ankle Injury
  • Severe Foot Injury
  • Major Soft Tissue Loss
  • Major Bone Articular Surface Loss
  • Major Ankle Articular Surface Loss

Sponsors & Collaborators

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Michael J Bosse, MD · Carolinas Medical Center

  • Lisa Reider, MHS, PhD · Johns Hopkins Bloomberg School of Public Health

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2019-09-20
Completion
2019-09-20

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606501 on ClinicalTrials.gov