Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000003572
Ethics application status
Approved
Date submitted
15/04/2023
Date registered
8/01/2024
Date last updated
8/01/2024
Date data sharing statement initially provided
8/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Surgical Approaches for Displaced Hand Fractures: A Clinical Study of Intramedullary Screws versus Dorsal Plates
Scientific title
Comparison of Intramedullary Screw Fixation vs Plate and Screws for Metacarpal Fractures: A Randomized Control Trial Assessing Total Active Motion, Grip Strength, Hand Function, Pain, Complication Rates, and Operative Time at 3, 6, and 12 Months
Secondary ID [1] 308865 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Plates or screw(s) in Metacarpals: POSIM Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The health condition studied is surgical procedures for displaced extra-articular metacarpal fractures. 328848 0
Condition category
Condition code
Injuries and Accidents 325846 325846 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Plates or Intramedullary Screws in Metacarpals: POSIM Trial

This study is designed to compare two standard surgical treatments for displaced extra-articular metacarpal fractures: dorsal plating and retrograde intramedullary screw(s). Participants will be randomly assigned to one of these two treatment groups.

The main intervention of interest is the retrograde intramedullary screw fixation, though the trial aims to evaluate the efficacy of both interventions.
The surgeries will be conducted by orthopaedic surgeons, who are not identified by name for this registration, with expertise in hand surgery.

In both treatment options, the expected duration, procedures, anesthesia, post-operative care, and other related elements remain the same. The only variation between the groups is the specific fixation method used, either screws or plates.

Follow-ups will be scheduled to assess the total active motion (TAM) of the involved digits, grip strength, hand function, and pain levels at intervals of 6 weeks, 3, 6, and 12 months after surgery.

To ensure consistency and fidelity to the intervention, an audit of hospital records, surgical procedure documentation, and regular monitoring by a designated clinical trial team will be carried out. This approach ensures adherence to the chosen intervention and allows for accurate reporting and assessment of the study outcomes.
Intervention code [1] 325311 0
Treatment: Surgery
Comparator / control treatment
The active control treatment for this study will be Dorsal Plating. Both Dorsal Plating and the reference treatment of Intramedullary Screw fixation will be performed under similar conditions. These include the same surgical settings, duration, anesthesia, post-operative care, and follow-ups. Participants will be randomly assigned to receive either Intramedullary Screw fixation or Dorsal Plating. Each of these methods will be executed by a qualified surgical team, consisting of a consultant surgeon, fellow, or SET-accredited registrar. The decision on the operative plan for each participant will be made following consultation with the supervising consultant.
Control group
Active

Outcomes
Primary outcome [1] 334489 0
The primary outcome of this study is to evaluate the effectiveness of dorsal plate versus intramedullary screw fixation techniques in regards to post-operative total active motion (TAM) in patients following extra-articular metacarpal fractures. TAM will be assessed using a goniometer, a device used to measure the angle of joint movement, to provide an accurate and standardized measurement of the range of motion in the involved digit at 6 weeks post-surgery.
Timepoint [1] 334489 0
6 weeks post-surgery
Secondary outcome [1] 420836 0
To evaluate dorsal plate verses intramedullary screw(s) fixation techniques regarding post operative total active motion (TAM) in patients following extra-articular metacarpal fractures. TAM will be assessed using a goniometer.
Timepoint [1] 420836 0
3-, 6- and 12-months post-surgery.
Secondary outcome [2] 420837 0
To evaluate dorsal plate verse intramedullary screw(s) fixation techniques regarding post operative grip strength in patient's following extra-articular metacarpal fractures. Grip strength measurements will be performed using a Hydraulic JAMAR Hand Dynamometer, which is the recognised standard of the measurement of grip strength. Measurements will be recorded in kilograms.
Timepoint [2] 420837 0
3, 6, 12 months post-surgery
Secondary outcome [3] 425971 0
The patient-rated outcomes in this study will be assessed using a standardised questionnaire: the Disabilities of the Arm, Shoulder and Hand (DASH) Score. This assessment will be conducted independently to gauge different aspects of the patients' hand functionality and quality of life post-surgery.
Timepoint [3] 425971 0
3, 6, 12 months post-surgery
Secondary outcome [4] 425972 0
Participants' pain levels in the affected finger will be assessed at each follow-up appointment using a Visual Analogue Scale (VAS). Pain will be rated on a 0 to 100 scale, with 0 indicating no pain and 100 indicating extreme pain. This scale provides a subjective but standardized measurement of the pain experienced by the patient.
Timepoint [4] 425972 0
3, 6, 12 months post-surgery
Secondary outcome [5] 430325 0
The MHQ score will be used as another distinct secondary outcome. This questionnaire evaluates overall hand function and quality of life from the patient’s perspective. It offers a comprehensive assessment of how the surgery has impacted the patient's daily life and hand-related activities.
Timepoint [5] 430325 0
3, 6, 12 months post-surgery

Eligibility
Key inclusion criteria
1. Adult patients (+18 years of age)
2. Less than 14 days between injury and surgery
3. Displaced extra-articular metacarpal fracture
4. Consultant surgeon decision to undergo operative fixation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pathological fracture
2. Significant soft tissue injury (large open injury requiring coverage with a graft or flap or tendon damage requiring repair)
3. Fracture only amenable to one mode of fixation, as decided by the treating Consultant Surgeon
4. Unable to comply with the assessment requirements or rehabilitation
5. Fracture best managed by non-operative treatment, as decided by the treating Consultant Surgeon
6. Fracture best managed by alternative fixation (e.g., Kirschner wires or lag screws) as decided by the treating Consultant Surgeon.

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 the use of an online randomisation and data storage service - REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participating patients will be randomised to dorsal plate or IMS fixation using a computer-generated system. Distance randomisation will be performed through an online randomisation and data storage service - REDcap. The medical officer, upon recruiting a patient, will enter the patient's details into REDcap, which will then provide the group allocation.
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
Following completion of data collection, data will be directed exported from REDcap into SPSS or STATA, both of which are available to the research team. Data will be visually inspected for any out-of-range values.
Descriptive data: will be presented as the aggregate value, mean, range, and percentage, using tables and figures as appropriate.
Continuous variables: will be assessed for significance using the appropriate t-test. Significance will be set to P<0.05, with the confidence interval of 95%.
Categorical data: association will be determined using Pearsons Chi2, with a Cramer’s V to assess confidence of association.
The Griffith University or GCHHS biostatistician will be consulted for support or guidance as necessary.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 24536 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 24537 0
Nepean Hospital - Kingswood
Recruitment hospital [3] 24538 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment postcode(s) [1] 40129 0
4215 - Southport
Recruitment postcode(s) [2] 40130 0
2747 - Kingswood
Recruitment postcode(s) [3] 40131 0
2077 - Hornsby

Funding & Sponsors
Funding source category [1] 313086 0
Hospital
Name [1] 313086 0
Gold Coast University Hospital
Country [1] 313086 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Services
Address
1 Hospital Boulevard, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 315460 0
None
Name [1] 315460 0
Address [1] 315460 0
Country [1] 315460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312331 0
Gold Coast University Hospital Human Research Ethics Committee
Ethics committee address [1] 312331 0
Ethics committee country [1] 312331 0
Australia
Date submitted for ethics approval [1] 312331 0
17/04/2023
Approval date [1] 312331 0
10/08/2023
Ethics approval number [1] 312331 0
HREC/2023/QGC/91413

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

Contacts
Principal investigator
Name 124282 0
Dr Fraser Taylor
Address 124282 0
Institution: Gold Coast Hospital and Health ServiceDepartment: Orthopaedics and Trauma 1 Hospital Boulevard, Southport, Qld 4215
Country 124282 0
Australia
Phone 124282 0
+61 756874860
Fax 124282 0
Email 124282 0
[email protected]
Contact person for public queries
Name 124283 0
Faraz Torabi
Address 124283 0
Institution: Griffith UniversityDepartment: School of Medicine and Dentistry Address: Parklands Drive, Southport Qld 4222
Country 124283 0
Australia
Phone 124283 0
+61 447726073
Fax 124283 0
Email 124283 0
[email protected]
Contact person for scientific queries
Name 124284 0
Faraz Torabi
Address 124284 0
Institution: Griffith UniversityDepartment: School of Medicine and Dentistry Address: Parklands Drive, Southport Qld 4222
Country 124284 0
Australia
Phone 124284 0
+61 447726073
Fax 124284 0
Email 124284 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


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.