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Trial registered on ANZCTR


Registration number
ACTRN12617000493347
Ethics application status
Approved
Date submitted
23/01/2017
Date registered
5/04/2017
Date last updated
5/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Distal Femur Fracture Healing in the Elderly Using Far Cortical Locking Screws.
Scientific title
Does far cortical locking improve fracture healing in elderly patients distal femur fractures: A randomised, controlled, prospective, multi-centre study
Secondary ID [1] 290984 0
none
Universal Trial Number (UTN)
U1111-1191-9004
Trial acronym
FCL trial
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Distal Femur Fracture 301738 0
Condition category
Condition code
Injuries and Accidents 301435 301435 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, randomised, controlled, double blinded (patient and investigator), multi-centre trial assessing bone healing of distal femoral fractures in the elderly population comparing Far Cortical Locking Screws (FCL) to standard locking screws (SL). FCL screws engage in the plate and the far cortex of the bone allowing a small amount of motion at the near cortex of fixation whereas the standard locking screws engage in the plate and both near and far cortices of the bone. The study population will comprise patients over the age of 60 years who have acute distal femoral fractures suitable for distal femoral locking plate fixation using a NCB fracture plate. A total of 100 patients will be enrolled in the study. Each patient will undergo standard surgical locking plate fixation of the distal femoral fracture using either 3-4 FCL screws for fixation of the proximal femoral fragment in the intervention group, or 3-4 standard NCB locking screws (NCB screw, Zimmer) for fixation of the proximal femoral fragment in the control group. The number of screws is predetermined by the length of the fracture and the treating physician and must be a minimum of 3 screws. The technique of bridged plating will be applied to both groups. The procedure is performed by an orthopaedic surgeon for both groups.
Intervention code [1] 296938 0
Treatment: Surgery
Intervention code [2] 297671 0
Treatment: Devices
Comparator / control treatment
Standard NCB locking screws
Control group
Active

Outcomes
Primary outcome [1] 300824 0
The primary study objective is defined as CT based radiological fracture healing at three months post-surgery with bridging callus on two or more cortices on at least two CT slices on a sagittal and coronal reconstruction. The assessment of radiographic fracture union will be assessed at a centralised location by an independent and qualified panel (including one Orthopaedic Surgeon and one Radiologist) blinded to the treatment, assessing the RUST score and cortical bridging on CT.
Timepoint [1] 300824 0
3 months post surgery for CT scan
Secondary outcome [1] 330971 0
Radiological healing on plain x-rays using the RUST score
Timepoint [1] 330971 0
2 years total follow up with time intervals for assessment of outcomes at: 6, 12, 18, 26 & 52 week
Secondary outcome [2] 333422 0
Assurance of fracture healing (defined as by the absence of screw or plate failure and delayed or non-union) assessed using radiographs and CT scans.
Timepoint [2] 333422 0
2 years total follow up with time intervals for assessment of outcomes at: 6, 12, 18, 26 & 52 week
Secondary outcome [3] 333423 0
volume of callus formation based on CT and radiographs
Timepoint [3] 333423 0
2 years total follow up with time intervals for assessment of outcomes at: 6, 12, 18, 26 & 52 week
Secondary outcome [4] 333424 0
demonstrate patient clinical satisfaction assessed using visual analog pain scale in the follow up questionnaire
Timepoint [4] 333424 0
2 years total follow up with time intervals for assessment of outcomes at: 6, 12, 18, 26 & 52 week

Eligibility
Key inclusion criteria
Age =/>60 years
Males and females
Capable of providing prospective informed consent
Acute distal femur fractures
Hip periprosthetic fractures and knee periprosthetic fractures
All fractures suitable for distal femur locking plate fixation
Informed patient consent available from patient or legal guardian
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient has a Glasgow Coma Scale score of less than 15 at the time of informed consent;
Patients below the age of 60 years;
Patients with limited life expectancy (likely unable to complete follow-up program);
The anticipated treatment plan for the fracture within the first 12 weeks after the surgical fixation includes procedures to promote fracture healing (such as the use of autogenous bone graft, allograft, bone graft substitute, use of ultrasound, magnetic field, or electrical stimulation).
The patient has persistent compartment syndrome or compartment syndrome with clinically significant neurovascular residua in the fractured limb under study.
The femoral fracture is pathological (except if due to idiopathic osteoporosis);
History of the heterotopic ossification at any site;
History of malignancy, radiotherapy, or chemotherapy for malignancy within the past two years except for basal cell carcinoma of the skin;
The patient is not willing to return for required follow-up visits;
Patients unable to comply with the rehabilitation and follow up programme;
Pre-morbid non-ambulatory patients;
Open fracture patterns (Gustilo garde III open fractures);
Periprosthetic fractures Vancouver Type B1, B2 & B3 at the hip joint & Rorabeck type 3
The patient has any other condition that, in the judgement of the Investigator, would prohibit the patient from participating in the study

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)
Central Randomisation by Phone/ fax or computer.

Patient details will be entered into a software program for generation of a randomisation number and allocation to either the FCL or SL arm of the study. This will be concealed from the patient and assessing investigator by keeping the allocation document confidential and private. Additionally, radiographs and CT scans taken will be assessed by means of independent assessors where the proximal fixation (i.e. the FCL or SL instrument) is blocked to eliminate bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done electronically through an online system based in Sydney whereby the treating team will log in to randomisation website and/or call a 24hour randomisation hotline to be assigned to SL or FCL treatment group. The software will generate a random number assigned to one arm of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be reviewed clinically and radiologically at 6 weeks, 12 weeks, 18weeks, 26 weeks, 1 year and a telephone consult at 2years. Clinical Review will involve history and examination and the data will be recorded in a questionnaire. Radiological analysis will be via plain film radiographs (x-rays) and a single CT scan at the three month follow up that will include a full leg length view (scout view for maquette assessment). Analysis of information will take place at the completion of the trial and will involve the following methods of assessment:

Modified RUST score analysis
Plate and screw failure/ breakage at six months
Number of patients healed at three months, six months and 1 year
CT callus qualification of bridging

At the completion of the study all the plain film radiographs and CT scans will be collected electronically and the fracture segment will be isolated in a picture format such that the fixation type (i.e. FCL or standard locking screw) cannot be identified. These images will be reviewed by a panel of experts blinded to the treatment (including 2 Orthopaedic Surgeons (one registrar and one consultant) and 1 Radiologist) to assess radiographic healing as per the parameters above (RUST score and cortical bridging on CT). The reviewers will be blinded as the fixation method on xray will be “blocked” out and CT sections restricted to limit analysis to the fracture site alone. All results will be recorded and analysed by a statistics team.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A null hypothesis and power analysis was conducted to estimate sample sizes. Exact logistic regression models, cox regression and advanced repeated measures power analysis were also used to estimate sample size. Final analysis will be conducted by a statistician once all data is available. There may be a preliminary analysis of data prior to completion of the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/10/2016
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 7360 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 7361 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 7362 0
Joondalup Health Campus - Joondalup
Recruitment hospital [4] 7363 0
The Alfred - Prahran
Recruitment hospital [5] 7364 0
The Northern Hospital - Epping
Recruitment hospital [6] 7365 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [7] 7366 0
St John of God Hospital, Ballarat - Ballarat
Recruitment hospital [8] 7367 0
Nepean Hospital - Kingswood
Recruitment hospital [9] 7368 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 7369 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 15155 0
6000 - Perth
Recruitment postcode(s) [2] 15156 0
6009 - Nedlands
Recruitment postcode(s) [3] 15157 0
6027 - Joondalup
Recruitment postcode(s) [4] 15158 0
3004 - Prahran
Recruitment postcode(s) [5] 15159 0
3076 - Epping
Recruitment postcode(s) [6] 15160 0
3350 - Ballarat Central
Recruitment postcode(s) [7] 15161 0
3350 - Ballarat
Recruitment postcode(s) [8] 15162 0
2747 - Kingswood
Recruitment postcode(s) [9] 15163 0
5000 - Adelaide
Recruitment postcode(s) [10] 15164 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 295399 0
Commercial sector/Industry
Name [1] 295399 0
Zimmer Biomet
Country [1] 295399 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital (Professor Markus Kuster)
Address
Department of Orthopaedics
Level 5, R Block
197 Wellington St, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 294237 0
None
Name [1] 294237 0
Address [1] 294237 0
Country [1] 294237 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296732 0
Royal Perth Hospital HREC ref REG 14-132
Ethics committee address [1] 296732 0
Ethics committee country [1] 296732 0
Australia
Date submitted for ethics approval [1] 296732 0
07/10/2014
Approval date [1] 296732 0
19/05/2015
Ethics approval number [1] 296732 0
REG 14-132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71918 0
Dr Humza Khan
Address 71918 0
PO Box 541, Floreat, WA, 6014
(Royal Perth Hospital)
Country 71918 0
Australia
Phone 71918 0
+61439924235
Fax 71918 0
na
Email 71918 0
humza.khan@health.wa.gov.au
Contact person for public queries
Name 71919 0
Markus Kuster
Address 71919 0
Department of Orthopaedics, Level 5, North Block, Wellington Street PERTH WA 6000
(Royal Perth Hospital)
Country 71919 0
Australia
Phone 71919 0
+61 9224 3531
Fax 71919 0
+61 9224 2005
Email 71919 0
Markus.Kuster@health.wa.gov.au
Contact person for scientific queries
Name 71920 0
Markus Kuster
Address 71920 0
Department of Orthopaedics, Level 5, North Block, Wellington Street PERTH WA 6000
(Royal Perth Hospital)
Country 71920 0
Australia
Phone 71920 0
+61 9224 3531
Fax 71920 0
+61 9224 2005
Email 71920 0
Markus.Kuster@health.wa.gov.au

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

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