Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000037808
Ethics application status
Approved
Date submitted
23/10/2020
Date registered
18/01/2021
Date last updated
18/01/2021
Date data sharing statement initially provided
18/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Plate or Screw in Proximal Phalangeal Fractures [POSI-P1]
Scientific title
A randomised controlled trial assessing total active motion in dorsal plating, lateral plating and intramedullary screws for displaced extra-articular proximal phalangeal fractures: the POSI-P1 Trial.
Secondary ID [1] 302608 0
None
Universal Trial Number (UTN)
U1111-1260-0801
Trial acronym
POSI-P1 trial
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Proximal phalangeal fractures 319497 0
Condition category
Condition code
Surgery 317460 317460 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exposure will be extra-articular proximal phalangeal fractures in adult patients [>18 years old], assessing extensor tendon splitting dorsal plating, extensor tendon sparing lateral plating and extensor tendon sparing intra-medullary screw fixation. In terms of the interventions administered:

1. Lateral plating involves a skin incision, and subluxation of the tendon to visualise the fracture. The plate is placed on the side of the bone [lateral position] and appropriate screws are used to fix the fracture, before the skin is closed. The operation will take roughly an hour, and will be performed by either qualified surgeons, or registrars under the guidance of surgeons

2. Intramedullary screw fixation involves a small percutaneous skin incision, before a guide wire is passed either antegrade [through the base of the proximal phalanx] or retrograde [through the end of the proximal phalanx] past the fracture. The fracture is reduced into an appropriate position, and a cannulated screw is inserted over the wire into the medullary canal of the phalanx to secure the fracture. The percutaneous skin incision is then closed. The operation will take roughly an hour, and will be performed by either qualified surgeons, or registrars under the guidance of surgeons
Intervention code [1] 318893 0
Treatment: Surgery
Comparator / control treatment
Dorsal plating is the current standard of care. Dorsal plating involves a skin incision and a longitudinal extensor tendon split, which allows access to the fracture. A plate is placed underneath the tendon [dorsal on the bone] with appropriate screws to fixate the fracture, before the tendon is repaired. This surgery takes roughly one hour, and will be administered once by trained orthopaedic or plastic surgeons, or training / non-training plastics and orthopaedic registrars under the guidance of trained surgeons.
Control group
Active

Outcomes
Primary outcome [1] 325492 0
Total active digital motion, as measured by a hand therapist using a goniometer
Timepoint [1] 325492 0
This will be measured at 6 weeks, 3 months, 6 months and 12 months post-operative. The primary timepoint will be the 12 month measurement
Secondary outcome [1] 388150 0
Patient reported outcome measures [The Quick Disabilities of Arm, Shoulder & Hand (QuickDASH) and the Michigan Hand Questionnaire (MHQ)], as a composite secondary outcome
Timepoint [1] 388150 0
This will be measured at 6 weeks, 3 months, 6 months and 12 months post-operative. The major timepoint of interest will be the 12 month measurement
Secondary outcome [2] 388151 0
Complications [infection, malunion or non-union], as assessed during the routine follow-up at 6 weeks, 3 months, 6 months and 12 months post-operative, as well as via review of the patient medical records
Timepoint [2] 388151 0
This will be measured at 6 weeks, 3 months, 6 months and 12 months post-operative. If the patient returns at any other time point due to one of these issues, this, too, will be recorded.The major timepoint of relevance will be the 12 month measurement
Secondary outcome [3] 388152 0
Rates of hardware removal, again as assessed during the routine follow-up as well as review of the patient medical records
Timepoint [3] 388152 0
Again, this will be measured and recorded at the 6 week, 3 month, 6 month and 12 month post-operative visits, with the major timepoint of relevance being the 12 month assessment.

Eligibility
Key inclusion criteria
Displaced extra-articular diaphyseal proximal phalangeal fracture on radiographs
Presentation within 14 days of injury
Skeletal maturity
Aged over 18 years old
Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Co-morbidities precluding surgery
Associated soft tissue injury [open / tendon damage]
Pathological fracture
Fracture only amenable to one mode of fixation, as decided by consultant surgeon
Unable to be compliant with rehabilitation or follow-up

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 computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
For the sample size calculation, the level of significance was 0.05 with a 2-sided test. Based on the work of Abubeih and Robinson, the standard deviation was set at 30.0. A minimum clinically important difference was judged to be 15.0 degrees in total active motion. With these parameters, a sample size of 64 per arm would be required to achieve a power of 80%. The sample size will be increased by 6 per arm to allow for early participant dropouts. Therefore, the sample size per arm will be 70, and 210 in total. It is projected that approximately 18 participants will be recruited at each site. Potential recruitment is believed to be fairly even across the sites, with no reason to believe that one site will experience increased recruitment compared to the others

Baseline demographic and injury data will be recorded and compared to ensure equality of all 3 treatment arms. This study will be assessed on an intention to treat basis, with any treatment switching reported and analysed separately. All outcomes data will be reported as means with ranges and standard deviations. All testing for associations will be 2-sided and reported with a 95% confidence interval, with the null hypothesis being rejected at a p value less than or equal to 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 17885 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 17886 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [3] 17887 0
The Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [4] 17888 0
Fairfield Hospital - Prairiewood
Recruitment hospital [5] 17889 0
Sydney Hospital and Sydney Eye Hospital - Sydney
Recruitment hospital [6] 17890 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 17891 0
Robina Hospital - Robina
Recruitment hospital [8] 17892 0
Varsity Lakes Day Hospital - Varsity Lakes
Recruitment postcode(s) [1] 31742 0
2065 - St Leonards
Recruitment postcode(s) [2] 31743 0
2077 - Hornsby
Recruitment postcode(s) [3] 31744 0
2086 - Frenchs Forest
Recruitment postcode(s) [4] 31745 0
2176 - Prairiewood
Recruitment postcode(s) [5] 31746 0
2000 - Sydney
Recruitment postcode(s) [6] 31747 0
4215 - Southport
Recruitment postcode(s) [7] 31748 0
4226 - Robina
Recruitment postcode(s) [8] 31749 0
4227 - Varsity Lakes

Funding & Sponsors
Funding source category [1] 307036 0
Charities/Societies/Foundations
Name [1] 307036 0
Australian Hand Surgery Society
Country [1] 307036 0
Australia
Funding source category [2] 307038 0
Commercial sector/Industry
Name [2] 307038 0
Accumed
Country [2] 307038 0
United States of America
Funding source category [3] 307039 0
Commercial sector/Industry
Name [3] 307039 0
Medartis
Country [3] 307039 0
Switzerland
Funding source category [4] 307040 0
Commercial sector/Industry
Name [4] 307040 0
LMT
Country [4] 307040 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Reserve Rd, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 307608 0
None
Name [1] 307608 0
Address [1] 307608 0
Country [1] 307608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307166 0
Gold Coast Hospital and Health Services HREC
Ethics committee address [1] 307166 0
Ethics committee country [1] 307166 0
Australia
Date submitted for ethics approval [1] 307166 0
Approval date [1] 307166 0
03/08/2020
Ethics approval number [1] 307166 0
HREC/2020/QGC/62750

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

Contacts
Principal investigator
Name 106262 0
Dr Brahman Sivakumar
Address 106262 0
Care of:

Department of Hand & Peripheral Nerve Surgery,
Royal North Shore Hospital
Reserve Rd, St Leonards, NSW 2065
Country 106262 0
Australia
Phone 106262 0
+61299267111
Fax 106262 0
Email 106262 0
[email protected]
Contact person for public queries
Name 106263 0
Brahman Sivakumar
Address 106263 0
Department of Hand & Peripheral Nerve Surgery, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 106263 0
Australia
Phone 106263 0
+61 299267111
Fax 106263 0
Email 106263 0
[email protected]
Contact person for scientific queries
Name 106264 0
Brahman Sivakumar
Address 106264 0
Department of Hand & Peripheral Nerve Surgery, Royal North Shore Hospital, Reserve Rd, St Leonards, NSW 2065
Country 106264 0
Australia
Phone 106264 0
+61 299267111
Fax 106264 0
Email 106264 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 outcome measures will be available on request for 5 years
When will data be available (start and end dates)?
Immediately following publication for up to 5 years
Available to whom?
For other investigators who are inquiring for their own research purposes
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
by contacting the primary investigator via email: [email protected]


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.