Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02297581
• Date of registration: 17/11/2014
• Prospective Registration: Yes
• Primary sponsor: AO Innovation Translation Center
• Public title: Geriatric Fracture Centers - Evaluation of a Geriatric Co-management Program
• Scientific title: A Prospective Multicenter Cohort Study to Evaluate the Benefit of the Geriatric Fracture Center (GFC) Concept
• Date of first enrolment: May 2015
• Target sample size: 282
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02297581
• Study type: Observational

Countries of recruitment

Austria, Netherlands, Singapore, Spain, Thailand, United States

Contacts

• Name: Michael Blauth, Professor
• Affiliation: Medical University of Innsbruck

Key inclusion & exclusion criteria

Preoperative Inclusion Criteria:

- Age = 70 years

- Geriatric patients with hip fractures Treated either with oOsteosynthesis or
oEndoprosthesis

- Ability of the patient or assigned representative to understand the content of the
patient information / Informed Consent Form

- Signed and dated Institutional Review Board (IRB) / Ethics Committee (EC)-approved
written informed consent

Preoperative Exclusion Criteria:

- Recent history of substance abuse (ie, recreational drugs, alcohol) that would
preclude reliable assessment

- Prisoner

- Participation in any other medical device or medicinal product study within the
previous month that could influence the results of the present study



Age minimum: 70 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hip Fractures

Primary Outcome(s)

Major Adverse Events related to treatment / residential status / immobilization [Time Frame: From surgery up to 1 year follow-up]

Secondary Outcome(s)

Time from admission to surgery [Time Frame: Baseline (admission to surgery), about 1-2 days]

Occurrence of a contralateral hip fracture [Time Frame: Retrospective assessment of pre-injury status up to 1 year follow-up]

Pain [Time Frame: From surgery up to1 year follow-up]

Number of re-admissions to an acute hospital [Time Frame: From surgery up to 1 year follow-up]

Time from admission to start of fluid management [Time Frame: Baseline (admission to surgery), about 1-2 days]

Mortality [Time Frame: From surgery up to 1 year follow-up]

Number of patients for which the nutrition status was evaluated / adapted [Time Frame: Baseline (admission to discharge), about 1-2 days]

Quality of Life [Time Frame: 12 weeks and 1 year postoperative]

Residential status [Time Frame: Baseline up to 1 year follow-up]

Medication [Time Frame: Baseline up to 1 year follow-up]

Number of patients receiving adequate secondary fracture prevention [Time Frame: Baseline up to 1 year follow-up]

Parker Mobility Score [Time Frame: Baseline, 12 weeks and 1 year follow-up]

Time from admission to start of pain medication [Time Frame: Baseline (admission to surgery), about 1-2 days]

Direct and indirect costs [Time Frame: Baseline up to 1 year follow-up]

Time from surgery to discharge 1 and 2 [Time Frame: Baseline (admission to discharge), about 1-2 weeks]

Activities of daily living [Time Frame: Baseline, 12 weeks and 1 year postoperative]

Any other AEs not mentioned under primary outcome measure(s) as well as its relationship to the treatment / residential status / immobilization [Time Frame: From surgery up to 1 year follow-up]

Falls [Time Frame: From surgery up to 1 year follow-up]

Timed up and go test (TUG) [Time Frame: 12 weeks and 1 year follow-up]

Secondary ID(s)

GFC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors