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

AO Innovation Translation Center

Status: Completed

Conditions: Hip Fractures

Study type: Observational

Funder types: Other

Identifiers

NCT02297581

GFC

Details and patient eligibility

About

The study will assess patients with at least one major AE related to treatment / hospitalization / immobilization in the Geriatric Fracture Center (GFC) group compared to the usual care group.

Full description

Patients aged ≥ 70 years or older with an osteoporotic hip fracture treated with an osteosynthesis or endoprosthesis will be included in this study.

The primary objective of the study is to assess the difference in the numbers of pre-defined major adverse events (AE) which are related to the treatment, hospitalization and/or immobilization between patients who were treated in a geriatric fracture center or in a usual care center.

As a secondary objective, health economic implications and cost-effectiveness comparison analyses will be performed.

In order to be able to analyze data based on the geographic regions as well as globally, in each participating country, both a Geriatric Fracture Center (GFC) and a Usual Care Center (UCC) will be included.

Enrollment: 282 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

282 participants in 2 patient groups

GFC: Geriatric Fracture Center

Description:

Patient treatment in a geriatric fracture center A GFC is defined as follows: * General geriatrician or ortho-geriatrician available in trauma/orthopaedic department * Geriatrician sees the patient prior to surgery (except if the patient is admitted over night or during weekends) * Local medical guidelines, consented by orthopedic surgeons and geriatrician * Pre-defined order set for assessing laboratory values * Pre-defined patient pathway to guarantee a fast track in the emergency room * Daily communication among involved specialists * Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): * Daily patient visit by geriatrician * Daily patient visit by orthopedic surgeon in combination with nurse * Daily therapy by physiotherapists, except for weekends * Access to social workers, if required

UCC: Usual Care Center

Description:

Patient treatment in an usual care center A UCC is defined as follows: * No geriatrician available in trauma/orthopaedic department * No pre-operative visit by a geriatrician as a standard * No pre-defined medical guidelines for geriatric fracture patients * Postoperative phase up to discharge from orthopaedic / trauma department (i.e. Discharge 1): * No daily patient visits by a geriatrician as a standard