Clinical Trial: Latin America Hip Fracture Mortality Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Latin America Hip Fracture Mortality Study

Brief Summary: The purpose of this study is to estimate the survival proportion one year after surgery for intertrochanteric fracture in older adults in Latin America.

Detailed Summary: This is a multi-center, prospective, observational clinical study to evaluate mortality in patients with surgically-treated hip fracture in Latin America, and investigate associated prognostic factors. Patients will be followed for 12 months.
Sponsor: AO Clinical Investigation and Documentation

Current Primary Outcome: Death [ Time Frame: after 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Harris Hip Score [ Time Frame: Screening/Preoperative and 90 ± 21 days ]
  • Parker Mobility Score [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90± 21 days, 365 (up to 425) days ]
  • Wound healing [ Time Frame: 30±7 days, 60±14 days, and 90± 21 days ]
  • Fracture healing [ Time Frame: 60±14 days and 90± 21 days ]
  • Anticipated surgical treatment-related adverse events [ Time Frame: Postoperative (2 to 5 days), 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ]
  • EQ-5D [ Time Frame: Screening/Preoperative, 30±7 days, 60±14 days, 90±21 days, 180±121 days, and 365 (up to 425) days ]


Original Secondary Outcome: Same as current

Information By: AO Clinical Investigation and Documentation

Dates:
Date Received: July 6, 2012
Date Started: January 2013
Date Completion:
Last Updated: January 23, 2017
Last Verified: January 2017