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Trial registered on ANZCTR


Registration number
ACTRN12619001023145
Ethics application status
Approved
Date submitted
26/05/2019
Date registered
17/07/2019
Date last updated
28/07/2023
Date data sharing statement initially provided
17/07/2019
Date results provided
28/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Fracture healing with distal femoral titanum locking plates in patients with distal femoral fractures
Scientific title
A comparative study of distal femoral locking plates for the fixation of distal femoral fractures: Long working length versus short working length titanum locking plates.
Secondary ID [1] 298330 0
‘Nil known’
Universal Trial Number (UTN)
U1111-1233-8548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fracture distal femur 312966 0
Condition category
Condition code
Injuries and Accidents 311480 311480 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name:
Distal femoral locking plates used for the treatment of distal femoral fractures and applied in two modes: Long working length versus short working length.
Materials:
Titanium distal femoral locking plates will be applied through surgery.
Procedures:
Surgery: Application of locking plates to patients of distal femoral fractures under anaesthesia and tourniquet control through lateral thigh incision in group A(long working length) and group B(short working length)
Who:
The operating surgeon will have minimum of 5 years post graduate experience in Orthopaedics & Traumatology
Mode of delivery:
It will be face to face.All patients with distal femoral fractures will be admitted in hospital in Orthopaedics & Traumatology Unit as soon as they are presented to hospital for treatment.After informed written consent each patient will operated upon individually.
Number of times:
Each patient in each group will be operated upon only once initially.(only one session) The duration of surgery(session) will last for one and half hour to two hours approximately.After surgery each patient will be seen face to face every 4th week for the first three months and then every three months till two years.If any complications of surgery is reported in the follow up visits,it will be dealt with accordingly at that time.
Location:
The intervention(surgery) will be performed on patients in Hospital(Lady Reading Hospital, Peshawar,Pakistan),This hospital is the biggest hospital of the province with a very large catchment area and all patients of long bone fractures are initially brought here for treatment.
personalised
what:
Patients of distal femoral fractures will be divided in two groups and operated upon with distal femoral locking plates applied in long working length or short working length mode.
why:
Variations in the working length of a titanium locking plate affect stiffness and interfragmentary movements of a fracture and its healing.We hypothesize that longer working length of a titanium locking plate has less nonunion and plate breakage rates
when:
As soon as the patients of distal femoral fractures are presented in hospital and they gave informed consent for surgery and participation in study, they will be operated upon.
How this will occur:
All patients of distal femoral fractures meeting the inclusion criteria presenting to hospital for treatment and willing for surgery will be enrollment in the study and will be operated in hospital. All the patients will be randomized into two groups i,e, group A(long working length) and group B(short working length). In the long working length plating all the combi screw holes overlying the fracture or comminution will be left empty plus two combi empty screw holes will be left proximal to the fracture in the intact bone.In the short working length no combi screw holes in the intact bone near the fracture will be left empty.
Intervention code [1] 314570 0
Treatment: Surgery
Comparator / control treatment
Patients with femoral fractures fixed with locking plates in Short working length mode.In the short working length locking plate no combi screw holes in the intact bone near the fracture will be left empty on either side.The treatment will be given to patients face to face in hospital through surgery and only once,The surgery will be performed by an experienced orthopaedics and trauma surgeon with minimum 5 years post graduate experience. After surgery each patient will be seen face to face every 4th week for the first three months and then every three months till two years.If any complications of surgery is reported in the follow up visits,it will be dealt with accordingly at that time.
Control group
Active

Outcomes
Primary outcome [1] 320357 0
Bone union will be assessed with xray by observing callus formation and disappearance of fracture lines.
Timepoint [1] 320357 0
8 months post operatively
Secondary outcome [1] 370795 0
infection(Composite secondary outcome)
assessed clinically by recording pain through Visual Analog Scale(VAS) ,swelling thigh measured with a tape and compare with the other normal thigh,discharge from wound site assessed visually and collecting the discharge with a swab on stick, fever recorded with a thermometer and biochemically elevated white cell count,raised ESR,raised CRP.
Timepoint [1] 370795 0
at follow up visit every 4th week for the first three months and then every three months till 8 months

Eligibility
Key inclusion criteria
The following fracture types will be included(AO classification):
• 33-A1=Extra-articular simple
• 33-A2= Extra articular metaphyseal wedge
• 33-A3= Extra articular metaphyseal complex
Received within one week after sustaining the fracture
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Open fractures
2. Polytrauma patients with other fractures like ipsilateral tibia or proximal femur fractures
3.Pathological fractures
4.Previously surgically treated fractures
5.Neuro Vascular injury/DVT
6.Periprosthetic fractures

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
All the patients of distal femoral fractures will be randomized into two groups
i,e, group A( locking plate applied in long working length mode) and group B(locking plate applied in short working length mode).
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Fractures of the distal femur accounts for 4% to 6% of all femur fractures .The sample size will be 76 with 80% power of the test and 95% confidence interval. Each group A(long working length) and group B(short working length) will have 38 patients based upon 16.6% non union in short working length plate and 0.7% non union in short working length plate. The sampling technique will be non probability convenient sampling.
Statistical analysis will be done by using SPSS version 20. Categorical variables like gender will be represented as frequency and percentage while mean±SD will be calculated for numerical variables like age.The significance of non union and implant failure between the two groups will be assessed with chi-square test. P value will be considered significant if < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2019
Actual
31/08/2019
Date of last participant enrolment
Anticipated
15/10/2021
Actual
20/10/2022
Date of last data collection
Anticipated
25/04/2023
Actual
26/04/2023
Sample size
Target
76
Accrual to date
Final
76
Recruitment outside Australia
Country [1] 21528 0
Pakistan
State/province [1] 21528 0
Khyber Pakhtunkhwa, Peshawar

Funding & Sponsors
Funding source category [1] 302872 0
Self funded/Unfunded
Name [1] 302872 0
Dr.Faaiz Ali Shah
Country [1] 302872 0
Pakistan
Primary sponsor type
Individual
Name
Dr.Faaiz Ali Shah
Address
Assistant Professor Department of Orthopaedics & Traumatology Lady Reading Hospital
Province/State: Khyber Pakhtunkhwa
City:Peshawar
Country:Pakistan
Street Name:Khyber Bazar
Code:24100
Country
Pakistan
Secondary sponsor category [1] 302824 0
None
Name [1] 302824 0
Address [1] 302824 0
Country [1] 302824 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303445 0
Lady Reading Hospital Medical Teaching Institution Institutional Review Board
Ethics committee address [1] 303445 0
Ethics committee country [1] 303445 0
Pakistan
Date submitted for ethics approval [1] 303445 0
12/02/2018
Approval date [1] 303445 0
27/04/2018
Ethics approval number [1] 303445 0
IRB/1804-17

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

Contacts
Principal investigator
Name 93686 0
Dr Faaiz Ali Shah
Address 93686 0
Assistant Professor Orthopaedics & Traumatology Lady Reading Hospital
Country:Pakistan
Province:Khyber Pakhtunkhwa
City:Peshawar
Street name:Khyber Bazar
Country 93686 0
Pakistan
Phone 93686 0
+92 3349125394
Fax 93686 0
Email 93686 0
faaizalisha@yahoo.com
Contact person for public queries
Name 93687 0
Faaiz Ali Shah
Address 93687 0
Assistant Professor Orthopaedics & Traumatology Lady Reading Hospital
Country:Pakistan
Province:Khyber Pakhuonkhwa
City:Peshawar
Street name: Khyber Bazar
Country 93687 0
Pakistan
Phone 93687 0
+92 3349125394
Fax 93687 0
Email 93687 0
faaizalisha@yahoo.com
Contact person for scientific queries
Name 93688 0
Faaiz Ali Shah
Address 93688 0
Assistant Professor Orthopaedics & Traumatology Lady Reading Hospital
Country:Pakistan
Province:Khyber Pakhtunkhwa
City:Peshawar
Street Name:Khyber Bazar
Country 93688 0
Pakistan
Phone 93688 0
+92 3349125394
Fax 93688 0
Email 93688 0
faaizalishah@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Gender
Age
Cause of fracture
Type of fracture
Pre and post op xray

Clinical pictures
Any complication
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator
email :faaizalishah@yahoo.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2178Informed consent form  faaizalishah@yahoo.com 377657-(Uploaded-16-07-2019-13-19-06)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.