Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001117909p
Ethics application status
Submitted, not yet approved
Date submitted
20/07/2020
Date registered
29/10/2020
Date last updated
29/10/2020
Date data sharing statement initially provided
29/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Two-corner fusion versus four-corner fusion for the treatment of wrist arthritis
Scientific title
The effectiveness of two-corner fusion versus four-corner fusion for the treatment of wrist arthritis associated with chronic scapholunate ligament tear (SLAC) or chronic scaphoid nonunion (SNAC): a prospective randomized controlled trial
Secondary ID [1] 301407 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wrist arthritis 317674 0
Scaphoid non-union advanced collapse (SNAC) 317675 0
Scapholunate advanced collapse (SLAC) 317676 0
Condition category
Condition code
Surgery 315754 315754 0 0
Surgical techniques
Musculoskeletal 316674 316674 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective randomised controlled trial of two-corner fusion versus four-corner fusion for wrist arthritis associated with scapholunate advanced collapse (SLAC) or scaphoid non-union advanced collapse (SNAC).

Patients with wrist pain and stiffness refractory to conservative measures, will be randomised to either a two- or four-corner fusion. Four-corner fusion (control gorup) is the routine practice for these conditions: it involves scaphoid excision and fusion of the lunate, capitate, triquetrum and hamate bones.

Two-corner fusion (study group) involves excision of scaphoid and triquetrum bones, and fusion of the luno-capitate joint.

Both surgeries will be performed by Orthopaedic surgeons with fellowship sub-specialty training in hand surgery. Duration of surgery is similar for both surgeries, being 60-90 minutes. No additional training is required for 2-corner fusion surgery.
Intervention code [1] 317714 0
Treatment: Surgery
Comparator / control treatment
4 corner fusion is the control group. This is the standard practice for wrist arthritis associated with SNAC/SLAC wrist conditions.
Control group
Active

Outcomes
Primary outcome [1] 324491 0
Patient Reported Outcome Measures (PROMS)- Mayo Wrist Score
Timepoint [1] 324491 0
Baseline, 2, 6 weeks
6 (Primary Endpoint), 12 and 24 months
Primary outcome [2] 324799 0
PROMs: Disabilities of Arm, Shoulder and Hand (DASH) score
Timepoint [2] 324799 0
2, 6 weeks
6 (Primary Endpoint), 12 and 24 months
Primary outcome [3] 324800 0
PROMS: Patient-rated Wrist Evaluation (PRWE)
Timepoint [3] 324800 0
2, 6 weeks
6 (Primary Endpoint), 12 and 24 months
Secondary outcome [1] 384803 0
Rates of Union based on 6 weeks post-operative CT; follow up imaging if not united at 6 weeks (6 and 12 months)
Timepoint [1] 384803 0
6 weeks, 6 and 12 months
Secondary outcome [2] 384804 0
Complications based on clinical examination (e.g. wound infection) and any subsequent need for surgery (e.g. non-union). The complications will be documented prospectively during the trial. Need for subsequent surgery will be flagged prospectively, and data from the surgery will be extracted from the hospital records.
Timepoint [2] 384804 0
2, 6 weeks
6, 12 and 24 months
Secondary outcome [3] 384805 0
Surgical time as measured from hospital records: nurse recorded surgical start and finish times and tourniquet time
Timepoint [3] 384805 0
At surgery
Secondary outcome [4] 384806 0
Cost of implants used (screws/plate constructs) as assessed via hospital records
Timepoint [4] 384806 0
At Surgery
Secondary outcome [5] 385783 0
Patient Satisfaction via study-specific questionnaires
Timepoint [5] 385783 0
12 months and 24 months

Eligibility
Key inclusion criteria
Patients with wrist pain and x-ray findings of SLAC/SNAC who have failed
conservative therapy, which includes analgesia, splinting, physio/hand therapy +/- trial of corticosteroid injections
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant women,
- Children and/or young people (<18 years)
- People with an intellectual or mental impairment
- People highly dependent on medical care

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)
Via a random sequence generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17123 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 17124 0
Glenferrie Private Hospital - Hawthorn
Recruitment hospital [3] 17125 0
The Valley Private Hospital - Mulgrave
Recruitment hospital [4] 17126 0
St John of God Hospital - Berwick - Berwick
Recruitment postcode(s) [1] 30799 0
3168 - Clayton
Recruitment postcode(s) [2] 30800 0
3122 - Hawthorn
Recruitment postcode(s) [3] 30801 0
3170 - Mulgrave
Recruitment postcode(s) [4] 30802 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 305844 0
Self funded/Unfunded
Name [1] 305844 0
A/Prof Eugene Ek
Country [1] 305844 0
Australia
Funding source category [2] 306478 0
Self funded/Unfunded
Name [2] 306478 0
Mr Jason Harvey
Country [2] 306478 0
Australia
Funding source category [3] 306479 0
Self funded/Unfunded
Name [3] 306479 0
Mr Steven Tham
Country [3] 306479 0
Australia
Primary sponsor type
Individual
Name
A/Prof Eugene Ek
Address
Division of Hand Surgery, Department of Orthopaedic Surgery
Dandenong Hospital
David St
Dandenong VIC 3175
Country
Australia
Secondary sponsor category [1] 306745 0
None
Name [1] 306745 0
Address [1] 306745 0
Country [1] 306745 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306109 0
Monash Health
Ethics committee address [1] 306109 0
Ethics committee country [1] 306109 0
Australia
Date submitted for ethics approval [1] 306109 0
11/07/2018
Approval date [1] 306109 0
Ethics approval number [1] 306109 0
RES-18-0000-366A

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

Contacts
Principal investigator
Name 102738 0
A/Prof Eugene Ek
Address 102738 0
Division of Hand Surgery, Department of Orthopaedics
Dandenong Hospital
David St
Dandenong VIC 3145
Country 102738 0
Australia
Phone 102738 0
+61 439068616
Fax 102738 0
Email 102738 0
[email protected]
Contact person for public queries
Name 102739 0
Gayan Padmasekara
Address 102739 0
Division of Hand Surgery, Department of Orthopaedics
Dandenong Hospital
David St
Dandenong VIC 3145
Country 102739 0
Australia
Phone 102739 0
+61 433061966
Fax 102739 0
Email 102739 0
[email protected]
Contact person for scientific queries
Name 102740 0
Gayan Padmasekara
Address 102740 0
Division of Hand Surgery, Department of Orthopaedics
Dandenong Hospital
David St
Dandenong VIC 3145
Country 102740 0
Australia
Phone 102740 0
+61 3 9554 1000
Fax 102740 0
Email 102740 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
We will provide aggregate data from the patients. Individual data will not be released.


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.