Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000286640p
Ethics application status
Not yet submitted
Date submitted
13/02/2023
Date registered
16/03/2023
Date last updated
19/09/2023
Date data sharing statement initially provided
16/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Intramedullary Nail versus Locking Plate in displaced three-part proximal humerus fractures.
Scientific title
Comparing Nail versus Locking Plate in displaced three-part proximal humerus fractures; A multi-centre randomized controlled trial (Otago PHINZ trial) investigating the effect on function post-operatively. .
Secondary ID [1] 308930 0
None
Universal Trial Number (UTN)
U1111-1288-0672
Trial acronym
PHINZ trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Displaced three-part Proximal Humerus Fractures 328936 0
Condition category
Condition code
Injuries and Accidents 325922 325922 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramedullary Nail (IMN) group:
Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will operate on patients under general anesthesia in the beach chair position with the elbow fixed at 90°. Skin will be opened via deltopectoral or deltoid split approach at surgeon's preference. Also, patients may have separate incisions as required. The greater and lesser tuberosities are re-approximated and sutured using non-absorbable suture. Once bony fragments are reduced, K-wires/sutures will be used under image intensifier guidance (fluoroscopy) to temporarily fix the head before implant use. Implant will be Tornier AEQUALIS Intramedullary Humeral Nail, a straight nail, 130 mm length and 8 mm distal diameter. This nail has 4 cannulated proximal screws to provide fixation perpendicular to fracture lines and to avoid reduction loss due to the pull-out force of rotator cuff. Two distal screws are designed to control rotation. The medullary canal is opened using cannulated drill and nail will then be inserted once the reduction is stable. The intraoperative duration for this procedure was reported between 50 to 85 minutes. Adherence to the intervention will be confirmed via checking randomization result in REDCap (Research Electronic Data Capture) where patients and treating members are aware of group allocation) and shoulder radiography during operation.
Intervention code [1] 325373 0
Treatment: Surgery
Comparator / control treatment
Locking Plate (LP) group:
Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will operate on patients under general anesthesia in the beach chair position with the elbow fixed at 90°. Skin will be opened via deltopectoral or deltoid split approach at surgeon's preference. The greater and lesser tuberosities are re-approximated and sutured using non-absorbable suture. Once bony fragments are reduced, K-wires/sutures will be used under image intensifier guidance (fluoroscopy) to temporarily fix the head before implant use. The implant will be PHILOS (DePuy-Synthes, Solothurn, Switzerland) stainless steel plate. The PHILOS is designed with three or five holes based on distal fracture extension. Intraoperative duration for this procedure was reported between 60 to 110 minutes. Adherence to the intervention will be confirmed via checking randomization result in REDCap (Research Electronic Data Capture) where patients and treating members are aware of group allocation) and shoulder radiography during operation.
Control group
Active

Outcomes
Primary outcome [1] 333763 0
Function using Disability of the Arm, Shoulder and Hand (DASH), (0-100), with the greater score representing more functional difficulties.
Timepoint [1] 333763 0
At 3, 6, 12 (primary time point), and 24 months post-surgery.
Secondary outcome [1] 418729 0
'Shoulder pain at rest' using Visual Analogue Scale, (0-10).
Timepoint [1] 418729 0
At 3, 6, 12 and 24 months post-surgery.
Secondary outcome [2] 418730 0
'Shoulder pain during activity' using Visual Analogue Scale, (0-10) .
Timepoint [2] 418730 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [3] 418731 0
Function using Constant Murley Score, (0-100), with greater score representing more functional impairment.
Timepoint [3] 418731 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [4] 418732 0
Function using American Shoulder and Elbow Surgeons (ASES) scores, (0-100), with higher score indicating better functional results.
Timepoint [4] 418732 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [5] 418733 0
Range of active arm flexion using goniometer.

Timepoint [5] 418733 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [6] 418734 0
Range of active arm abduction using goniometer.
Timepoint [6] 418734 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [7] 418735 0
Range of active arm external rotation using goniometer.
Timepoint [7] 418735 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [8] 418736 0
Range of active arm internal rotation using a tape measure.


Timepoint [8] 418736 0
At 3, 6, 12, and 24 months post-surgery.
Secondary outcome [9] 418737 0
Complication; Composite Malreduction and/or malunion; Data is collected by independent radiologists via anteroposterior and trans-scapular Y view radiographs. Mal reduction is defined as neck shaft angle (NSA) < 120°, or tuberosity displacement > 0.5 cm. Presence of osseous abnormalities including malposition of greater or lesser tuberosity, incongruity of the articular surface, and malalignment of the articular segment will be referred as malunion. Composite data will be collected because malunion usually occurs following malreduction.
Timepoint [9] 418737 0
At 3- and 12- months post-surgery.
Secondary outcome [10] 418738 0
Complication; Osteonecrosis of the humeral head. Data is collected by independent radiologists via anteroposterior and trans-scapular Y view radiographs. Osteonecrosis of the humeral head will be verified by MRI when there are features of osteonecrosis on anteroposterior and trans-scapular Y view radiographs indicating that patient needs to refer for MRI scan.
Timepoint [10] 418738 0
At 3- and 12-months post-surgery.
Secondary outcome [11] 418739 0
Complication; Nonunion of the fracture; .Data is collected by independent radiologists via anteroposterior and trans-scapular Y view radiographs. Nonunion will be the lack of union requiring unplanned surgical intervention or incomplete radiologic healing at 12 months.
Timepoint [11] 418739 0
At 12-months post-surgery.
Secondary outcome [12] 418741 0
Complication: Screw penetration/screw cut out. Data is collected by independent radiologists via anteroposterior and trans-scapular Y view radiographs. Screw penetration/screw cut out will refer the screw violation from articular surface as a result of humeral head collapse.
Timepoint [12] 418741 0
At 3- and 12-months post-surgery.
Secondary outcome [13] 418742 0
Complication: Displacement of internal fixation. Data is collected by independent radiologists via anteroposterior and trans-scapular Y view radiographs.
Timepoint [13] 418742 0
At 3- and 12-months post-surgery.
Secondary outcome [14] 418743 0
Complication: Hardware failure. Hardware failure will be referred as breakage of an implant. Data is collected by independent radiologists via anteroposterior and trans-scapular Y view radiographs.
Timepoint [14] 418743 0
At 3- and 12-months post-surgery.
Secondary outcome [15] 418744 0
Total complication (i.e., a composite incidence of superficial and deep wound infection, loss of fixation and metal work failures). Total complication rate will be collected from REDCap by the main investigator as binary data (Yes or No). This will be reported by counting the ratio of patients presented with complications to total patients at 12 months.
Timepoint [15] 418744 0
At 12 months post-surgery.

Eligibility
Key inclusion criteria
Patients above 18 years old with displaced three-part proximal humerus fractures based on the Neer classification will be included. In three-part fractures, either the lesser or greater tuberosity is displaced with associated displacement of the surgical neck producing a rotational deformity. Displaced fractures will be defined as a dislocation more than 1 cm or with an angle greater than 45° between head and diaphysis of humerus. The type of fractures will be classified according to the Neer-classification.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be fractures extending to the humeral shaft or articular split, fractures more than 4 weeks old, or open fractures. Patients will be excluded if they are identified with concomitant ipsilateral fractures of distal humerus/or elbow joint, previous surgery of affected shoulder, pathologic fracture (i.e., malignancy fractures), neurovascular injuries (e.g., stroke or brachial plexus injuries), neurological disorders (e.g., Parkinson, or multiple sclerosis), or cognitive disorders (i.e., sever mental illness). Intra operative changes of treatment due to small diameter of humerus shaft, fracture line through the nail entry point or severely reduced bone quality resulting in fixation problems with either implants will be excluded.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence using blocks of 4 with a 1 to 1 ratio, IMN and LP groups. Stratified randomization based on age group (18-40 Y, 41-70 Y, 71-80 Y, and 81 and above Y) will be performed in each treating centre to ensure the normal distribution of patients for each arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This is a superiority designed study recruiting eligible participants with dislocated 3-part proximal humerus fractures in parallel groups comparing intramedullary nail (IMN) with Locking plate (LP).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation:
The sample size will be calculated for the superiority of Nail over Plate surgery for DASH score as primary outcome measure. Considering 80% of statistical power, a significant test set at 0.05 for two-tailed test, and a 8-point difference in DASH scores between two groups at 12 months, at least 89 participants is required for each arm . For the potential of 20% drop-out, 107 participants will be required in each group. Retrospective data of operative PHF indicated 50 ORIF surgeries for three-part fractures from in Christchurch hospital from 2020 to 2022. If this trend continues, we anticipate recruiting 16 participants per year from Christchurch hospital. Given approximately the same amount of recruitment in other three centres (Auckland, Wellington, and Dunedin), the estimated annual recruitment is 64 participants for a period of 3.5 years in each centre.

Statistical analysis:
All statistical analysis will be completed using SPSS (version 28.0; IBM Corporation, Armonk, NY). The Skewness and Kurtosis analysis will be performed to test the normal distribution of data. Continuous normally distributed data will be presented as mean and SD and non-normally distributed data will be reported as median and range to summarize characteristics of participants at baseline and each time points. For continuous data with normal distribution, we will use paired t-test for within group differences, and independent t-test for between group differences. For continuous data with non-normal distribution, we will use Wilcoxon signed ranks test for calculating within group and Mann-Whitney U test for between group differences. Categorical data will be reported as number and percentage. The frequency of variances between two groups will be compared using chi-squared test (X2). We will use multiple regression analysis to estimate the effects of age, sex and treatment group on function scores. For categorical data, we will use logistic regression to estimate the effects of age, sex and intervention on complication rates. Age, and group allocation will be considered as independent variables and function scores (DASH, ASES and Constant Murley Score) and complication rates will be considered as dependent variables. For all statistical analysis, P-value will be set at = 0.05. Patients will be analysed according to intention to treat and multiple imputation will be used for missing data at random.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
15/12/2028
Actual
Date of last data collection
Anticipated
14/09/2029
Actual
Sample size
Target
214
Accrual to date
Final
Recruitment outside Australia
Country [1] 25249 0
New Zealand
State/province [1] 25249 0
Canterbury

Funding & Sponsors
Funding source category [1] 313139 0
Hospital
Name [1] 313139 0
Christchurch Hospital
Country [1] 313139 0
New Zealand
Primary sponsor type
University
Name
University of Otago-Christchurch
Address
2 Riccarton Avenue,Christchurch, Canterbury 8011.
Country
New Zealand
Secondary sponsor category [1] 314885 0
Government body
Name [1] 314885 0
Health Research Council
Address [1] 314885 0
Health Research Council of New Zealand, Level 1 South Tower, 110 Symonds Street, Grafton, Auckland 1010
Country [1] 314885 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312383 0
Southern Health and Disability Ethics Committee (Southern HDEC)
Ethics committee address [1] 312383 0
Ethics committee country [1] 312383 0
New Zealand
Date submitted for ethics approval [1] 312383 0
11/04/2023
Approval date [1] 312383 0
Ethics approval number [1] 312383 0

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

Contacts
Principal investigator
Name 124466 0
Dr Zohreh Jafarian Tangrood
Address 124466 0
Orthopaedic surgery and MSM research, 2 Riccarton Avenue, Christchurch, 8011
Country 124466 0
New Zealand
Phone 124466 0
+64 223013366
Fax 124466 0
Email 124466 0
[email protected]
Contact person for public queries
Name 124467 0
Zohreh Jafarian Tangrood
Address 124467 0
Orthopaedic surgery and MSM research, 2 Riccarton Avenue, Christchurch, 8011
Country 124467 0
New Zealand
Phone 124467 0
+64 223013366
Fax 124467 0
Email 124467 0
[email protected]
Contact person for scientific queries
Name 124468 0
Zohreh Jafarian Tangrood
Address 124468 0
Orthopaedic surgery and MSM research, 2 Riccarton Avenue, Christchurch, 8011
Country 124468 0
New Zealand
Phone 124468 0
+64 223013366
Fax 124468 0
Email 124468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be presented as group. When analyzing data, we will use code for each participant to ensure participant anonymity.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18307Informed consent form  [email protected] 385352-(Uploaded-14-03-2023-07-05-33)-Study-related document.docx
18586Study protocol    385352-(Uploaded-14-03-2023-07-06-19)-Study-related document.docx



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.