ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00224367

Registration number

NCT00224367

Ethics application status

Date submitted

21/09/2005

Date registered

23/09/2005

Date last updated

23/09/2005

Titles & IDs

Public title

Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?

Scientific title

Does Early Ambulation After Hip Fracture Surgery Accelerate Recovery?: A Randomised Controlled Trial

Secondary ID [1]

Award number A33429

Secondary ID [2]

T10414

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Fractured Hip

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

functional outcome day 7 post-operation

Timepoint [1]

Secondary outcome [1]

discharge destination

Timepoint [1]

Secondary outcome [2]

length of stay

Timepoint [2]

Eligibility

Key inclusion criteria

Consecutive patients admitted via the emergency department to The Alfred hospital Melbourne, for surgical fixation of an acute fracture of the hip (by a compression screw and plate or a hemiarthroplasty) -

Minimum age

0 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

fracture was pathological, postoperative orders were for non-weight bearing on the operated hip, the patient was admitted from a nursing home or the patient was non-ambulant pre-morbidly. -

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/02/2004

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

3141 - Melbourne

Funding & Sponsors

Primary sponsor type

Government body

Name

Bayside Health

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Hip fractures are a significant problem for healthcare providers due to the increasing incidence of fractures in an ageing population. Hip fracture is the most frequent fracture for people over 80 years of age and the second most frequent for those over 65 years. It is projected that by 2051, 23% of the Australian population will be older than 65 and the number of hip fractures will rise fourfold (17,000 in 2004, to 60,000 in 2051).

Evidence-based clinical practice guidelines regarding management of hip fracture were published in the Medical Journal of Australia in 1999 and updated in 2003. Seventeen aspects of treatment were systematically reviewed, including mobilisation after surgery. Early assisted ambulation within 48 hours post surgery was recommended (Chilov 2003 p 490). However, the recommendation was based on observational (level 3) evidence only.

Early mobilization post surgery is resource intensive. Early mobilization is challenging and uncomfortable for the patient and requires the assistance of one or sometimes two, physiotherapists available seven days per week. Benefits must be rigorously evaluated to justify recommendation. We undertook a randomized controlled trial of the effect of two different 'time to first ambulation' intervals after hip fracture surgery on patient and hospital outcomes.Our hypothesis was that early mobilisation would accelerate functional recovery after hip fracture surgery.

Trial website

https://clinicaltrials.gov/study/NCT00224367

Trial related presentations / publications

Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.

Public notes

Contacts

Principal investigator

Name

Leonie B Oldmeadow, D.Physio

Address

The Alfred

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00224367

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00224367