ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000549921

Ethics application status

Approved

Date submitted

11/10/2019

Date registered

11/05/2020

Date last updated

22/07/2022

Date data sharing statement initially provided

11/05/2020

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of non-weight bearing following surgical intervention for lower limb fracture on frailty.

Scientific title

Effect of non-weight bearing following surgical intervention for lower limb fracture on frailty.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1241-8054

Trial acronym

IFNOF

Linked study record

Health condition

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

Frailty

Lower Limb Fracture

Condition category

Condition code

Public Health

Health service research

Injuries and Accidents

Fractures

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The study is an observational prospective cohort study aiming to determine whether a non-weight bearing post surgical management of lower limb fracture is associated with increased risk of frailty.

Patients that decide to participate in the study will be required to provide informed consent. After consent is obtained several questionnaires will be supplied, medical records will be reviewed and finally a physical test will be carried out.

Patients (community dwelling individuals above 65 years old with fractures to the lower extremities and undergoing surgery) will be allocated to one of three groups based on the clinical management prescribed by the treating surgeons and physicians:

- Non weight bearing (NWB):No weight can be placed on the operated leg. Therefore, assistive device such as walker or crutches is required.
- Partial weight bearing (PWB): Allows the patient to place half of their weight on the operated leg.
- Full weight bearing (FWB): Allows the patient to place all of their weight on the operated leg, there is no restrictions in the amount of weigth placed on the extremity, therefore, no assistive device is required.

Patients will have follow up appointments 6 weeks and 12 weeks post-surgery.

Each appointment will have a duration of approximately 1.5 hours.

As this is an observational prospective cohort study, clinical management prescribed by treating physicians will not be affected by the involvement of the patient in this study.

Intervention code [1]

Not applicable

Comparator / control treatment

Control Group: Full Weight Bearing
Participants allocated in this group are participants that as per surgeon or physician assessments are able to walk without having a restrictive weight on the injured limb.

Control group

Active

Outcomes

Primary outcome [1]

Frailty: assessed by the Rockwood's 60 point Frailty Index and Hand Grip Test

Timepoint [1]

Baseline
6 weeks
12 weeks

Secondary outcome [1]

Length of stay: assessed by the inspection of medical records and discharge summaries.

Timepoint [1]

6 weeks
12 weeks

Secondary outcome [2]

Rate of transfer to residential aged care facility: assessed by the inspection of medical records.

Timepoint [2]

6 weeks
12 weeks

Secondary outcome [3]

Mortality

Timepoint [3]

6 weeks
12 weeks

Eligibility

Key inclusion criteria

• Community dwelling
• Age equal or greater than 65
• Admitted with fractures of lower extremities (hip, femur, tibia and fibula)
• Surgical intervention for lower extremity fracture.

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

• Patients with lower extremities fractures who are not considered for surgical management
• Nursing home residents
• Terminal illness
• Presence of known active malignancy
• Severe dementia, requiring full nursing care at home.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Due to lack of literature assessing the effect of weight bearing on frailty, power calculations were not possible. The desired overall sample size for this study is 300, considering that there is not a randomly allocation of patients to treatment. Therefore, with this sample size, it is expected that at least 30 participants are allocated to each group. Participants allocation to each group will not be equal.

30 patients per group would allow a detection of 0.7 standard deviations difference in frailty index and/or hand grip strength. Due to pilot study nature, it is expected that power of the study will be below 80%;

Patient data will be grouped according to management strategy; NWB, PWB and FWB. Baseline characteristic will be compared between groups. Primary and secondary outcomes at baseline, 6 weeks and 12 weeks will be compared between groups using non parametric test (pair-wise comparison of continuous variables using rank sum and Fisher’s exact for categorical variables).

Providing at least 20-30 non weight bearing patient are recruited, ANCOVA will be used for analysis of primary outcome at 6 and 12 weeks, adjusting for baseline value of the outcome. Appropriate transformations will be performed if required. If the sample size enable, linear regression will be used with adjustments for confounders. Secondary outcomes will be assessed using logistic regression (mortality and requirement for residential care within the study period) or negative binomial regression (length of stay) with adjustment for potential confounders.

Time to death will be analysed using Kaplan-Meier and Cox regression with adjustment for confounders if sufficient number of outcomes occur in each group.

Data will be analysed according to intention to treat. Additional analysis with be undertaken to investigate the effect of compliance on analysis.

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

Actual

26/03/2019

Date of last participant enrolment

Anticipated

30/06/2020

Actual

3/06/2019

Date of last data collection

Anticipated

30/10/2020

Actual

Sample size

Target

300

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Sunshine Hospital - St Albans

Recruitment hospital [2]

Footscray Hospital - Footscray

Recruitment hospital [3]

Williamstown Hospital - Williamstown

Recruitment postcode(s) [1]

3021 - St Albans

Recruitment postcode(s) [2]

3011 - Footscray

Recruitment postcode(s) [3]

3016 - Williamstown

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australian Institute of Musculoskeletal Science

Address [1]

Sunshine Hospital
176 Furlong Rd
St Albans VIC 3021

Country [1]

Australia

Primary sponsor type

Hospital

Name

Western Health

Address

Sunshine Hospital
176 Furlong Rd
St Albans VIC 3021

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Human Research Ethics Committee

Ethics committee address [1]

Level 2
South West
300 Grattan Street
Parkville Victoria 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2018

Approval date [1]

01/03/2019

Ethics approval number [1]

HREC/44486/MH-2018

Summary

Brief summary

Injury resulting from falls is a significant contributor to hospitalisation of older Australians.  Fractures resulting from falls can also lead to long term health consequences including decreased mobility and independence, reduced quality of life and even increase risk of death.  While there is a great deal of research investigating effectiveness of different management strategies for healing of bones, there is limited knowledge on the overall effect of post-surgical management on health outcomes of patients following discharge from hospital.  The current evidence does not clearly define which strategy is best in which patients, therefore the different treatment strategies under investigation are all part of current clinical practice.

Frailty is defined as a state of reduced physiological reserve due to accumulated deficits which increases the individual’s vulnerability to adverse health outcomes.  The current study aims to investigate the effect of different management strategies, during their hospital stay, for patients who have undergone surgery to repair a fracture of their lower limb on the likelihood they will develop frailty.  Frailty will be measured using Frailty Index and hand grip strength.  We will measure frailty soon after surgery and at 6 and 12 weeks following their surgery to investigate whether the type of treatment increases the likelihood of patients meeting the definition for frailty.  

This study will observe outcomes in patients grouped according to the treatment prescribed by their treatment team as 1. mobilisation (weight-bearing) 2. partial or 3. total immobilisation (non-weight bearing). The study will not affect the care of the participants.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Gustavo Duque

Address

The University of Melbourne
Level 3 WCHRE, Sunshine Hospital
176 Furlong Rd, St Albans
VIC 3021

Country

Australia

Phone

+61 3 83958212

Fax

gustavo.duque@unimelb.edu.au

Contact person for public queries

Name

Gustavo Duque

Address

The University of Melbourne
Level 3 WCHRE, Sunshine Hospital
176 Furlong Rd, St Albans
VIC 3021

Country

Australia

Phone

+61 3 83958212

Fax

gustavo.duque@unimelb.edu.au

Contact person for scientific queries

Name

Gustavo Duque

Address

The University of Melbourne
Level 3 WCHRE, Sunshine Hospital
176 Furlong Rd, St Albans
VIC 3021

Country

Australia

Phone

+61 3 83958212

Fax

gustavo.duque@unimelb.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No individual participant data will be available. Overall data presented in publications, seminars or presentations will be in a de-identified manner

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
5274	Study protocol			gustavo.duque@unimelb.edu.au
5275	Informed consent form			gustavo.duque@unimelb.edu.au

Results publications and other study-related documents

Documents added manually

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Documents added automatically

No additional documents have been identified.

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