NCT04755686

Brief Summary

The purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

3 years

First QC Date

June 10, 2013

Last Update Submit

February 12, 2021

Conditions

Keywords

hip fracturefast-trackingcomplications

Outcome Measures

Primary Outcomes (1)

  • Incidence of complications (composit endpoint of non-fatal major bleeding, pressure ulcer, non-fatal infections, confusion, non-fatal tromboembolic events, all-cause mortality)

    at time of discharge from geriatric medicine ward, after four months and after one year

Secondary Outcomes (1)

  • Length of hospital stay, time to operation, all-cause mortality, functional ability after discharge, proportion of patients returning to former living, self assessed health status

    At time of discharge from geriatric medicine ward, after four months and after one year

Study Arms (2)

Fast-tracking at geriatric medicine ward

EXPERIMENTAL

Fast-tracking hip fracture patients at geriatric medicine ward. The goal is to optimize the medical care of older hip fracture patients at a geriatric ward and to shorten the time to operation.

Procedure: Fast-tracking

Regular admission

NO INTERVENTION

Regular admission and care of hip fracture patients at the emergency room prior to surgery.

Interventions

Fast-trackingPROCEDURE
Fast-tracking at geriatric medicine ward

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • patients with low energy trauma with pain at the hip and/or groin AND
  • respiratory frequency: 8-25/minute AND
  • saturation: 90% or higher on air AND
  • pulse: 50-119 beats per minute AND
  • systolic blood pressure: \>90 mmHg AND
  • level of consciousness: Reaction level scale (RLS) 1 or Glasgow Coma Scale (GCS) 14-15 AND
  • plasma-glucose: 3,0-25 mmol/l

You may not qualify if:

  • We will exclude patients based on the following criteria:
  • distal status affected
  • suspicion of other simultaneous fracture
  • suspicion of head trauma or affected consciousness
  • suspicion of acute cardiac disease
  • signs of acute cardiac ischemia in electrocardiogram
  • generalized symtoms, except for pain in the hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, Mölndal

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Mattias Lorentzon, MD, PhD

    Geriatric Medicine, Sahlgrenska University Hospital, Mölndal

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD, PhD

Study Record Dates

First Submitted

June 10, 2013

First Posted

February 16, 2021

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations