Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000109909
Ethics application status
Approved
Date submitted
16/01/2020
Date registered
7/02/2020
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating outcomes of above-knee versus below-knee nailing of tibial shaft fractures.
Scientific title
Evaluating functional outcomes of suprapatellar versus infrapatellar approach for intramedullary nailing of tibial shaft fractures.
Secondary ID [1] 300285 0
Nil known
Universal Trial Number (UTN)
U1111-1246-6001
Trial acronym
SPN vs IPN
Suprapatellar nailing versus infrapatellar nailing
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial shaft fracture 315864 0
Condition category
Condition code
Injuries and Accidents 314145 314145 0 0
Fractures
Emergency medicine 314146 314146 0 0
Other emergency care
Musculoskeletal 314147 314147 0 0
Other muscular and skeletal disorders
Surgery 314148 314148 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tibial shaft fractures are commonly treated with intramedullary nailing. Anterior knee pain is an often reported complication after this surgery. The aetiology of anterior knee pain remains unclear, but the surgical approach may play an important role. This study will compare suprapatellar nailing versus infrapatellar nailing of tibial shaft fractures.

Infrapatellar nailing is an extra-articular approach, where the nail is inserted below the patella. Infrapatellar nailing can be performed transtendinous, whereby the patella tendon is split, or by lateral or medial retraction of the patella tendon (lateral or medial parapatellar approach) with the knee in a flexed or hyper-flexed position. Suprapatellar nailing is an intra-articular technique, where the nail is inserted from above the patella using a quadriceps incision. Suprapatellar nailing allows the knee to remain in an extended position.

Existing methodologies used to assess the outcomes of tibial shaft fracture patients treated with intramedullary nailing have yet to be biomechanically validated, and the optimal intramedullary nailing technique based on patient satisfaction remains unknown and requires further study.

This pilot study will follow a prospective randomised controlled design at the Royal Adelaide Hospital (South Australia). We aim to recruit a total of 60 patients between the ages of 18 – 60 years old, who will be randomly assigned to one of the approaches after a decision has been made for surgical fixation. Patients who do not consent to the study will not be included and will receive standard clinical care. For patients consenting to the study, we will follow the patients up to 18 months post-operatively to compare the outcomes between groups.
Patients will undergo surgery after fracture at times in line with local protocols, and the surgery will be performed by the normal surgical team at the hospital for that day. No changes to timings or personnel will be made.

Post-operatively, all patients will be mobilised and fully weight bearing as able and will follow standard physiotherapy and rehabilitation regimes.

Each surgery will be conducted by an orthopaedic surgeon and will take approximately 30 – 45 minutes. Fidelity of the procedure is assessed by radiographic image intensifier by the orthopaedic surgical team operating that day, as is standard clinical care. All nails used in this study will be Stryker T2 Alpha nails.
Intervention code [1] 316557 0
Treatment: Surgery
Intervention code [2] 316558 0
Treatment: Devices
Comparator / control treatment
Infrapatellar nailing approach
Control group
Active

Outcomes
Primary outcome [1] 322535 0
Knee injury and Osteoarthritis Outcome Score
Timepoint [1] 322535 0
12 months
Secondary outcome [1] 378856 0
Knee injury and Osteoarthritis Outcome Score
Timepoint [1] 378856 0
3, 6, 18 months
Secondary outcome [2] 378857 0
Functional Joint Score-12 Knee
Timepoint [2] 378857 0
3, 6, 12, 18 months
Secondary outcome [3] 378858 0
Quality of life (via EQ-5D-5L questionnaire)
Timepoint [3] 378858 0
3, 6, 12, 18 months
Secondary outcome [4] 378859 0
Gait assessment using 3D motion capture technology (2 x AMTI force platforms, Delsys EMG, Vicon motion tarcking)
Timepoint [4] 378859 0
3, 6, 12, 18 months
Secondary outcome [5] 378860 0
Max isometric thigh muscle strength (MicroFET2 digital handheld dynamometer)
Timepoint [5] 378860 0
3, 6, 12, 18 months
Secondary outcome [6] 378861 0
Kneeling tolerance (Aberdeen Weight-Bearing Test (Knee) using 2 x AMTI force platforms)
Timepoint [6] 378861 0
3, 6, 12, 18 months
Secondary outcome [7] 378862 0
Tibial alignment (using post-operative radiographs)
Timepoint [7] 378862 0
6 weeks, 3, 6, 18 months
Secondary outcome [8] 378863 0
Time to union (as indicated on post-operative radiographs)
Timepoint [8] 378863 0
6 weeks, 3, 6, 12, 18 months
Secondary outcome [9] 378864 0
Return to work (as time from surgery).
This will be recorded through a patient-reported outcome questionnaire, designed specifically for this study. This questionnaire captures whether the patient has been able to return to work, or if they haven't returned to work, if the reason is related to their leg fracture or knee pain that may be associated with their surgery. This is administered at 3, 6, 12, 18 months.
Timepoint [9] 378864 0
patient-reported outcome questionnaire administered at 3, 6, 12, 18 months

Eligibility
Key inclusion criteria
18 – 60 years old at the time of inclusion;
Unilateral, extra-articular, tibial shaft fractures;
Intramedullary fixation is the preferred treatment of the fracture as determined by the surgeon on call
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fractures involving the tibial metaphysis (upper ¼ of the tibia);
Other major trauma to the lower limbs (except for ipsilateral fibular fractures);
ASA-classification of 3 or more at the time of inclusion.

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 concealed by sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomly permuted blocks schedule was created with two treatment arms (labelled A and B) with equal allocation over four strata (Males under 40, Females under 40, Males 40 and over, Females 40 and over). Two block sizes (2 and 4) were used which were allocated in equal proportions. A unique, non-informative, 3-digit study subject identifier was generated for each treatment allocation. Fifty allocations were generated per stratum with a total of 200 allocations.

The randomisation schema was generated using Stata v15.1 and the user-written Stata package ralloc
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot study, no sample size calculations have been performed. All biomechanical data and imaging data will be presented as descriptive statistics and the normality of the data interrogated prior to any formal analysis being performed. The patient reported outcomes measures will be reported as descriptive statistics to describe the cohort at each time point.

Linear mixed effect modelling with post-hoc t-tests will be used to compare within group changes in gait parameters and functional tests between post-operative time-points (3, 6, 12, 18 months) for each surgical approach.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15627 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 29029 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304699 0
Commercial sector/Industry
Name [1] 304699 0
Stryker
Country [1] 304699 0
Australia
Primary sponsor type
Individual
Name
A/Prof Mark Rickman
Address
Department of Orthopaedics & Trauma
Royal Adelaide Hospital
Port Road, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 305009 0
Individual
Name [1] 305009 0
A/Prof Dominic Thewlis
Address [1] 305009 0
Centre for Orthopaedic and Trauma Research
Adelaide Health and Medical Science Building
North Terrace, Adelaide, SA, 5000
Country [1] 305009 0
Australia
Secondary sponsor category [2] 305023 0
Individual
Name [2] 305023 0
Simon Thwaites
Address [2] 305023 0
Centre for Orthopaedic and Trauma Research
Adelaide Health and Medical Science Building
North Terrace, Adelaide, SA, 5000
Country [2] 305023 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305117 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305117 0
Ethics committee country [1] 305117 0
Australia
Date submitted for ethics approval [1] 305117 0
14/08/2019
Approval date [1] 305117 0
29/08/2019
Ethics approval number [1] 305117 0
11949
Ethics committee name [2] 305133 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 305133 0
Ethics committee country [2] 305133 0
Australia
Date submitted for ethics approval [2] 305133 0
27/09/2019
Approval date [2] 305133 0
30/09/2019
Ethics approval number [2] 305133 0
33968

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

Contacts
Principal investigator
Name 99326 0
A/Prof Mark Rickman
Address 99326 0
Department of Orthopaedics & Trauma
Royal Adelaide Hospital
Port Road
Adelaide S A 5000
Country 99326 0
Australia
Phone 99326 0
+61427722738
Fax 99326 0
Email 99326 0
[email protected]
Contact person for public queries
Name 99327 0
Mark Rickman
Address 99327 0
Department of Orthopaedics & Trauma
Royal Adelaide Hospital
Port Road
Adelaide S A 5000
Country 99327 0
Australia
Phone 99327 0
+61427722738
Fax 99327 0
Email 99327 0
[email protected]
Contact person for scientific queries
Name 99328 0
Dominic Thewlis
Address 99328 0
Centre for Orthopaedic & Trauma Research
Adelaide Health and Medical Sciences Building
North Terrace, Adelaide, SA, 5000
Country 99328 0
Australia
Phone 99328 0
+61883137096
Fax 99328 0
Email 99328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified motion capture data will be made available. This data does not contain video footage and can in no way be used to identify patients.
When will data be available (start and end dates)?
Start: April 2020
End: December 2022 (last data collection).

Data will be made available on Figshare. See details below on how to access.
Available to whom?
The de-identified motion capture data will be made available to researchers who provide a methodologically sound proposal
Available for what types of analyses?
Musculoskeletal modelling
How or where can data be obtained?
Data will be made available on Figshare (online repository) with access subject to approvals by Principal Investigator.

Prinicpal Investigator contact:
A/Prof Mark Rickman: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6447Analytic code    Code will be made available at completion of the s... [More Details]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInvestigating and defining outcomes of suprapatellar versus infrapatellar intramedullary nailing of tibial shaft fractures: a protocol for a pilot randomised controlled trial.2022https://dx.doi.org/10.1186/s40814-022-01057-5
N.B. These documents automatically identified may not have been verified by the study sponsor.