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Trial registered on ANZCTR


Registration number
ACTRN12623001048673
Ethics application status
Approved
Date submitted
12/09/2023
Date registered
27/09/2023
Date last updated
28/01/2024
Date data sharing statement initially provided
27/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between Nail and Plate surgeries for fixation of a broken upper arm
Scientific title
Comparing Nail versus Locking Plate in patients with displaced three-part proximal humerus fractures; A randomized controlled pilot trial (PHINZ trial) investigating the feasibility of a definitive RCT.
Secondary ID [1] 310572 0
None
Universal Trial Number (UTN)
U1111-1297-7518
Trial acronym
Pilot PHINZ trial
Linked study record
The current study will be a pilot trail of the same intervention that will be examined in a large RCT with the registration number of ACTRN12623000286640.

Health condition
Health condition(s) or problem(s) studied:
Displaced three-part Proximal Humerus Fractures 331429 0
Condition category
Condition code
Injuries and Accidents 328172 328172 0 0
Fractures
Surgery 328260 328260 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramedullary Nail (IMN) group:
The study will be performed at Christchurch Hospital. Orthopaedic surgeons with experience of at least five Nail and Plate operations (N=10 in total) will contribute to operation. Patients will be operated 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] 326976 0
Treatment: Surgery
Comparator / control treatment
Locking plate (LP) group
The study will be performed at Christchurch Hospital. Orthopedic 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 through 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 head before implant use. The implant will be PHILOS (DePuy-Synthes, Solothurn, Switzerland) stainless steel plate with three or five holes based on distal fracture extension. Once the reduction is satisfactory with K-wires, PHILOS will be replaced using locked screws. The intraoperative duration for plate surgery has been reported a range between 60 and 110 minutes (Plath et al., 2019; Zhu et al., 2011). The adherence to operation will be confirmed via plain radiography taken during the operation to be matched with group allocation after operation.
Control group
Active

Outcomes
Primary outcome [1] 336049 0
Disability of the Arm, Shoulder and Hand (DASH), Scoring from 0-100 in which a higher score represents more functional difficulties.
Timepoint [1] 336049 0
At 3, and 6 months (Primary time point) post-surgery.
Secondary outcome [1] 426645 0
Function using Constant Murley scores: scoring from 0 to 100 with greater score represents more functional impairment.
Timepoint [1] 426645 0
At 3, and 6 months post-surgery.
Secondary outcome [2] 426646 0
Function using American Shoulder and Elbow Surgeons (ASES) score, 0-100 with higher score indicates better functional results.
Timepoint [2] 426646 0
AT 3, and 6 months post-surgery.
Secondary outcome [3] 426647 0
Pain at rest using VAS, 0-10 with higher score representing more pain.
Timepoint [3] 426647 0
At 3, and 6 months post-surgery.
Secondary outcome [4] 426650 0
Pain during arm movement using VAS, 0-10 with higher score representing more pain.
Timepoint [4] 426650 0
At 3, and 6 months post-surgery.
Secondary outcome [5] 426651 0
Range of active arm flexion using goniometer.
Timepoint [5] 426651 0
At 3, and 6 months post-surgery.
Secondary outcome [6] 426652 0
Range of active arm abduction using goniometer.
Timepoint [6] 426652 0
At 3, and 6 months post-surgery.
Secondary outcome [7] 426653 0
Range of active arm external rotation using goniometer.
Timepoint [7] 426653 0
At 3, and 6 months post-surgery.
Secondary outcome [8] 426654 0
Range of active arm internal rotation using goniometer.
Timepoint [8] 426654 0
At 3, and 6 months post-surgery.
Secondary outcome [9] 426655 0
Mal-reduction or malunion, composite data will be collected as malunion usually occurs following mal-reduction. Mal-reduction will be defined as neck shaft angle (NSA) < or = 120°, or tuberosity displacement > 0.5 cm in anteroposterior radiographic image. The research assistant will collect the data from surgeon or radiologist report based on updated x-rays.
Timepoint [9] 426655 0
At 3, and 6 months post-surgery.
Secondary outcome [10] 426656 0
Non-union: no progression of radiographic fracture healing that is judged to require additional surgical treatment for fracture healing by the treating surgeon. The research assistant will collect the data from surgeon or radiologist report based on updated x-rays.
Timepoint [10] 426656 0
At 3, and 6 months post-surgery.
Secondary outcome [11] 426657 0
Screw penetration/Screw cut-out will refer the screw violation from articular surface as the result of humeral head collapse. The research assistant will collect the data from surgeon or radiologist report based on updated x-rays.
Timepoint [11] 426657 0
At 3, and 6 months post-surgery.
Secondary outcome [12] 426658 0
Osteonecrosis of the humeral head will be verified by an MRI if features of osteonecrosis on an x-ray indicate that the patient needs to be referred for the MRI scan. The research assistant will collect the data from surgeon or radiologist report based on updated imaging reviews.
Timepoint [12] 426658 0
At 3, and 6 months post-surgery.
Secondary outcome [13] 426659 0
Displacement of internal fixation. The research assistant will collect the data from surgeon or radiologist report based on updated x-rays.
Timepoint [13] 426659 0
At 3, and 6 months post-surgery.
Secondary outcome [14] 426660 0
Hardware failure will be referred as breakage of the implant. The research assistant will collect the data from surgeon or radiologist report based on updated x-rays.
Timepoint [14] 426660 0
At 3, and 6 months post-surgery.
Secondary outcome [15] 426661 0
Total complication will be the composite data of wound, and fixation failures reported as binary data (yes/no) collected from patient medical record. It will be calculated by the ratio of patients with complications than all participants.
Timepoint [15] 426661 0
At 6 months post-surgery.

Eligibility
Key inclusion criteria
Patients with displaced three-part proximal humerus fractures based on 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Fractures extending to the humeral shaft
2) Articular split,
3) fractures more than 4 weeks old,
4) open fractures.
5) Concomitant ipsilateral fractures of distal humerus/ or elbow joint,
6) Previous surgery of affected shoulder,
7) Pathologic fracture (malignancy fractures),
8) Neurovascular injuries (e.g., stroke, or brachial plexus injuries),
9) Neurological disorders (e.g., Parkinson, or multiple sclerosis) or cognitive disorders (i.e., sever mental illness).
10) Intra operative changes of treatment due to small diameter of humerus shaft to use nail, fracture line through the nail entry point or severely reduced bone quality resulting in fixation problems with either implants.

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 will be concealed through central randomisation by REDCap manager.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified computer-generated randomization based on age group (18-50 Y, and 51 Y and above) will be performed using blocks of 4 with a 1 to 1 ratio, nail and plate groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size estimation
As the rationale of this pilot trial is to investigate the feasibility of a future RCT, and following consultation with a biostatistician (Dr J Williman), we have determined that a sample size of 12 participants is appropriate to test trial processes.

Statistical analysis
Descriptive statistic will be used as median and range for continuous data and number and percentage for categorical data. As this is not a pragmatic RCT, analysing the differences will not be the goal of this trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
15/01/2024
Date of last participant enrolment
Anticipated
14/06/2024
Actual
Date of last data collection
Anticipated
25/12/2024
Actual
Sample size
Target
12
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 25766 0
New Zealand
State/province [1] 25766 0
Canterbury

Funding & Sponsors
Funding source category [1] 314781 0
Government body
Name [1] 314781 0
Health Research Council of New Zealand (hrc nz)
Country [1] 314781 0
New Zealand
Primary sponsor type
University
Name
University of Otago-Christchurch
Address
Orthopaedic Surgery and Musculoskeletal Medicine, Christchurch Hospital, 2 Riccarton Ave, City centre, Christchurch, 8011
Country
New Zealand
Secondary sponsor category [1] 316767 0
None
Name [1] 316767 0
Address [1] 316767 0
Country [1] 316767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313790 0
Central Health and Disability Ethics Committees (Central HDEC)
Ethics committee address [1] 313790 0
Ministry of Health, 133 Molesworth street, Wellington 6011
Ethics committee country [1] 313790 0
New Zealand
Date submitted for ethics approval [1] 313790 0
28/08/2023
Approval date [1] 313790 0
22/09/2023
Ethics approval number [1] 313790 0

Summary
Brief summary
Our objective is to conduct a preliminary randomized controlled trial (RCT) to build the capacity for a large-scale RCT. We will compare Intramedullary Nail (IMN) and Locking Plate (LP) fixation for three-part Proximal Humerus Fractures (PHFs).
The pilot trial involves 12 patients aged above 18 with displaced three-part PHFs, randomly assigned to IMN or LP groups. Standard surgical procedures and post-operative rehabilitation will be provided. We will assess pain using the Visual Analogue Scale and functional outcome using 'Disability of the Arm, Shoulder, and Hand' (DASH), 'Constant Murley,' and 'American Shoulder and Elbow Surgeons' (ASES) assessments at 3- and 6-months post-surgery. Complications will be monitored during clinical visits. This study will establish a research team and test RCT aspects before a multi-center RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129358 0
Dr Zohreh Jafarian Tangrood
Address 129358 0
Orthopaedic Surgery and Musculoskeletal Medicine, Christchurch Hospital, 2 Riccarton Ave, Christchurch 8011
Country 129358 0
New Zealand
Phone 129358 0
+64 223013366
Fax 129358 0
Email 129358 0
zohreh.jafarian@otago.ac.nz
Contact person for public queries
Name 129359 0
Dr Zohreh Jafarian Tangrood
Address 129359 0
Orthopaedic Surgery and Musculoskeletal Medicine, Christchurch Hospital, 2 Riccarton Ave, Christchurch 8011
Country 129359 0
New Zealand
Phone 129359 0
+64 223013366
Fax 129359 0
Email 129359 0
zohreh.jafarian@otago.ac.nz
Contact person for scientific queries
Name 129360 0
Dr Zohreh Jafarian Tangrood
Address 129360 0
Orthopaedic Surgery and Musculoskeletal Medicine, Christchurch Hospital, 2 Riccarton Ave, Christchurch 8011
Country 129360 0
New Zealand
Phone 129360 0
+64 223013366
Fax 129360 0
Email 129360 0
zohreh.jafarian@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Descriptive statistics will be used for outcome measures in each group. Data will be de-identified by computer generated code to conserve participants confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



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.