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Trial registered on ANZCTR

Registration number

ACTRN12618001431213

Ethics application status

Approved

Date submitted

6/08/2018

Date registered

27/08/2018

Date last updated

27/08/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluating the treatment methods of proximal femur fractures in elderly trauma patients

Scientific title

A multi-centre, single blinded prospective randomised controlled trial of the Gamma 3 intramedullary nail to the unlocked and locked Intertan intramedullary nail for the treatment of proximal femur fractures.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1215-6062

Trial acronym

ProFNUL
Proximal Femoral Nail Unlocked vs. Locked

Linked study record

Health condition

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

Proximal femur fracture

Condition category

Condition code

Injuries and Accidents

Fractures

Emergency medicine

Other emergency care

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Neck of femur fractures are common, and generally treated with surgery. One of the commonly used devices is an intramedullary (IM) nail with proximal fixation extending into the femoral head. There are numerous devices on the market, all with individual data, but there is very little comparative evidence. The majority of IM nail designs have a proximal ‘lag screw’ which can be used in either static or dynamic modes. There is no published evidence regarding which of these modes is better.

The study will follow a prospective randomized controlled design at the Royal Adelaide Hospital, with patients also recruited at Flinders Medical Centre, The Queen Elizabeth Hospital and Lyell McEwin Hospital (South Australia). We aim to recruit a total of 900 trauma patients aged over 60 years, who will be randomly assigned to receive one of two different femoral nail designs (both designs are current standards on the market), as well as two different locking modes. Patients will be randomised to receive either the INTERTAN™ nail (Locked proximally), the INTERTAN™ nail (Unlocked proximally), or a Gamma nail (Unlocked proximally) for fracture fixation, after a decision to undergo surgical treatment for their fracture has already been made. Patients who refuse to consent to the study will not be included in the study and routine clinical practice will be carried out. For patients consenting to the study, we will follow the patients for a minimum of six months (or until the fracture has healed) and compare the outcomes of the groups.

The patients will undergo surgery at the earliest opportunity in line with local protocols and surgery will be carried out by the normal surgical team at the hospital for that day – no changes will be made to timings or personnel involved. The device and mode of locking will be as per the randomization outcome.

Post operatively all patients will be mobilised fully weight bearing as able, and follow a standard physiotherapy / rehabilitation regime.

Each surgery will be conducted by an orthopaedic surgeon and will take approximately 30-45 minutes. Fidelity of the procedure will be assessed via radiographic image intensifier via the normal orthopaedic surgical team operating on that day.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Unlocked Gamma 3 nail

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome measure for the trial is 'failure of the device' at any point up to six months following surgery. (% of failure for each device). This will be assessed via anterior-posterior (AP) and lateral plain film radiographs.

'Device failure' is defined as any of the following occurring :
- Lag screw cut-out requiring revision surgery
- Nail fracture
- Locking screw fracture
- A change in Tip-Apex distance of more than 10mm

Timepoint [1]

Six months after intervention commencement

Secondary outcome [1]

Number of Injury specific complications (including per-operative technical complications, surgical site infection, unplanned surgery, death).

This data will be collected through a series of four forms that a clinician/orthopaedic surgeon will complete. These forms are electronic, allowing the data to be automatically compiled into a spreadsheet. One form is completed peri-operatively (medical imaging and operative information), one at patient discharge (medical records and clinical assessment), one at the six week follow up review (clinical assessment and patient reported), and one at the six month follow up review (clinical assessment and patient reported). Complications data will be collected indirectly as part of these forms. Additionally, if patients report complications and thus present to clinic, these patients will be clinically reviewed by a clinician and x-rays taken, as per standard procedure. In these events, the occurrence of these complications are recorded against the patients hospital number.

Timepoint [1]

Up to 12 months after intervention commencement

Secondary outcome [2]

Functional independence assessed via Functional Independence Measure (FIM score)

Timepoint [2]

Baseline (taken pre-operative), and at discharge, six weeks and six months after intervention commencement

Secondary outcome [3]

Timed Up and Go test

Timepoint [3]

At six weeks, six months and 12 months after intervention commencement

Secondary outcome [4]

Re-operation for any reason.

Operation data will be collected through a form, completed by one of the orthopaedic surgeons of surgical team. This information is collected by the anaesthesia team’s notes as well as the orthopaedic surgeon’s case notes.

Timepoint [4]

Up to 12 months after intervention commencement

Secondary outcome [5]

General medical complications (grouped and collected on a tick-list).

This is collected by the medical team as the patient is enrolled into the study onto a series of forms which the clinicians will complete. (Forms outlined in secondary outcome [1]).

Timepoint [5]

Up to 12 months after intervention commencement

Secondary outcome [6]

Return to mobility circumstances (i.e. use of services at six and 12 months compared to pre-fracture)

This information will be collected at discharge through a form, completed by one of the ward nurses. This information is patient reported.

Timepoint [6]

At six weeks, six months and 12 months after intervention commencement

Secondary outcome [7]

Gross motor activity (human rest-activity cycles).

This will be collected via a wrist worn actigraphy device.

Timepoint [7]

At six weeks, six months and 12 months after intervention commencement

Secondary outcome [8]

Operation time

Timepoint [8]

At the time of intervention commencement

Secondary outcome [9]

number of intra-operative complications

Timepoint [9]

At the time of intervention commencement

Secondary outcome [10]

Fluoroscopy time

Timepoint [10]

At the time of intervention commencement

Secondary outcome [11]

Tip-Apex Distance of femoral nail lag screw.

This operation data will be collected through a form, completed by one of the orthopaedic surgeons of surgical team. This information is collected by the orthopaedic surgeon’s case notes.

Timepoint [11]

At time of intervention commencement

Secondary outcome [12]

Return to mobility circumstances.

This information will be collected at discharge through a form, completed by one of the ward nurses. This information is patient reported.

Timepoint [12]

Up to 12 months after intervention commencement

Secondary outcome [13]

Hip joint range of motion.

This will be collected using objective measures from gait analysis

Timepoint [13]

At six weeks, six months and 12 months after intervention commencement.

Secondary outcome [14]

Hip joint contact forces and moments.

This will be collected using objective measures from gait analysis

Timepoint [14]

At six weeks, six months and 12 months after intervention commencement.

Secondary outcome [15]

Post operative hip muscle function (abductors, flexors, extensors).

This will be collected using objective measures from gait analysi and musculoskeletal modelling.

Timepoint [15]

At six weeks, six months and 12 months after intervention commencement.

Secondary outcome [16]

Post operative hip muscle asymmetry.

This will be collected using objective measures from gait analysis and musculoskeletal modelling.

Timepoint [16]

At six weeks, six months and 12 months after intervention commencement.

Secondary outcome [17]

Nail and screw sizes used by the operating orthopaedic surgeon.

This operation data will be collected through a form, completed by one of the orthopaedic surgeons of surgical team. This information is collected by the anaesthesia team’s notes as well as the orthopaedic surgeon’s case notes.

Timepoint [17]

At the time of intervention commencement.

Secondary outcome [18]

Harris Hip Score (HHS)

Timepoint [18]

at six weeks, six months and 12 months after intervention commencement

Secondary outcome [19]

Visual Analog Scale (VAS) pain score

Timepoint [19]

At six weeks, six months and 12 months after intervention commencement

Secondary outcome [20]

Functional Independence Measure (FIM)

Timepoint [20]

At six months after intervention commencement

Eligibility

Key inclusion criteria

1. Traumatic extracapsular hip fracture
2. Closed injury
3. Patient aged over 60 years
4. Ability to be followed for up to six months
5. Presentation to hospital within 14 days of injury

Minimum age

60 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients with concomitant injuries affecting treatment and rehabilitation of the affected limb.
2. Patients with associated neurovascular injuries requiring immediate surgery
3. Patients where consent is refused
4. Patient with limited English proficiency including family members

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)

Allocation concealment is done via centralised computerised randomisation (Griffith Randomisation Service).

Allocation concealment is the same for all participants enrolled in the study.

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

Randomisation using computerised generation with stratified allocation factors of gender and Abbreviated Mental Health Test Score (ATMS) for all participants consenting to the study.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Gamma nail failure rates in the literature have been reported to vary from 2 to 15%, so a mid-range value is 7.5%. Abram et al (2013) used mechanical failure (complete lag screw cut-out, nail or locking screw fracture) as an end point and found a 7.2% failure rate over a 5 year period from 299 cases. A clinically significant difference between the control group (Gamma3 Nail) and each of the intervention groups separately (unlocked and locked intertan nail) would be difference of 5% between the 2 intervention groups. Therefore using a significance level of 0.05 and power of 80%, allowing for 30% loss to follow up at 6 months (including 10% mortality) and a 1.5 variance inflation factor to allow for repeated measurements over time results in a requirement for approximately 300 patients in each of the 3 groups (control group - Unlocked Gamma3 Nail, and each of the Intervention Groups - Unlocked & Locked Intertan Nail).

Continuous data such as the FIM, HHS and pain scores will be analysed using a two-sided t-test to compare the two-independent groups. Categorical outcomes will be analysed using a chi-squared test. The statistician performing the analysis will be blinded to the treatment groups.

Data from the gait analysis, musculoskeletal modelling and activity monitoring will be assessed in combination with the randomised groups and analysed using a linear mixed model.

Abram SG, Pollard TC, Andrade AJ. Inadequate 'three-point' proximal fixation predicts failure of the Gamma nail. The bone & joint journal. 2013:31018.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/09/2018

Actual

Date of last participant enrolment

Anticipated

25/12/2020

Actual

Date of last data collection

Anticipated

20/12/2021

Actual

Sample size

Target

900

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [2]

Flinders Medical Centre - Bedford Park

Recruitment hospital [3]

The Queen Elizabeth Hospital - Woodville

Recruitment hospital [4]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5000 - Adelaide

Recruitment postcode(s) [2]

5042 - Bedford Park

Recruitment postcode(s) [3]

5011 - Woodville

Recruitment postcode(s) [4]

5112 - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Smith & Nephew Pty Ltd

Address [1]

Level 1,66 Rundle Street, Kent Town SA 5067

Country [1]

Australia

Primary sponsor type

Individual

Name

A/Prof Mark Rickman

Address

Dept. of Orthopaedics & Trauma, Royal Adelaide Hospital
Port Road
Adelaide SA 5000

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

A/Prof Dominic Thewlis

Address [1]

Adelaide Health and Medical Science Building,
Cnr North Terrace and George Street
Adelaide SA 5000

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Arjun Sivakumar

Address [2]

Adelaide Health and Medical Science Building,
Cnr North Terrace and George Street
Adelaide SA 5000

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

CALHN Research Office
RAH Clinical Trial Centre
Wayfinder 3D460.02
Level 3, Royal Adelaide Hospital
Port Road
ADELAIDE SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2017

Approval date [1]

24/02/2018

Ethics approval number [1]

HREC reference number: HREC/17/RAH/433, CALHN Reference number: R20171010 Rickman

Summary

Brief summary

Neck of femur fractures are common, and generally treated with surgery. One of the most commonly used devices is an intra-medullary nail. There are numerous devices on the market, all with individual data, but there is very little comparative evidence. The majority of IM nail designs have a proximal ‘lag screw’ which can be used in either static or dynamic modes. There is no published evidence regarding which of these modes is better. We aim to recruit a total of 900 trauma patients aged over 60, who will be randomly assigned to receive one of 2 different nail designs, as well as 2 different locking modes. We will then follow the patients for a minimum of 6 months (or until the fracture has healed) and compare the clinical and functional outcomes of the groups. Of the 900 patients randomised into the study, the first 100 from each of the three randomised arms of the study will be selected for the observational element of the study involving gait analysis and activity monitoring. We hypothesize that there is a difference in clinical and functional outcomes between patients managed with the Gamma or INTERTAN nailing systems, in either locking mode.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Mark Rickman

Address

Dept. of Orthopaedics & Trauma, Royal Adelaide Hospital
Port Road
Adelaide SA 5000

Country

Australia

Phone

+61427722738

Fax

[email protected]

Contact person for public queries

Name

A/Prof Mark Rickman

Address

Dept. of Orthopaedics & Trauma, Royal Adelaide Hospital
Port Road
Adelaide SA 5000

Country

Australia

Phone

+61427722738

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Dominic Thewlis

Address

Centre for Orthopaedic & Trauma Research, University of Adelaide
Cnr North Terrace and George Street
Adelaide SA 5000

Country

Australia

Phone

+61883137096

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23647	Study protocol	Sivakumar A, Thewlis D, Ladurner A, et alProximal Femoral Nail Unlocked versus Locked (ProFNUL): a protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur fracturesBMJ Open 2020;10:e032640. doi: 10.1136/bmjopen-2019-032640	https://bmjopen.bmj.com/content/10/2/e032640
23648	Ethical approval				HREC reference number: HREC/17/RAH/433 CALHN Refe... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Gait biomechanics after proximal femoral nailing of intertrochanteric fractures.	2023	https://dx.doi.org/10.1002/jor.25427
Embase	Proximal Femoral Nail Unlocked versus Locked (ProFNUL): A protocol for a multicentre, parallel-armed randomised controlled trial for the effect of femoral nail mode of lag screw locking and screw configuration in the treatment of intertrochanteric femur fractures.	2020	https://dx.doi.org/10.1136/bmjopen-2019-032640

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically