Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000169842
Ethics application status
Approved
Date submitted
16/12/2020
Date registered
18/02/2021
Date last updated
18/02/2021
Date data sharing statement initially provided
18/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Total wrist fusion with and without the carpometacarpal joint in isolated wrist arthritis
Scientific title
A randomised control trial of post-operative complications and patient reported outcomes following total wrist arthrodesis in isolated wrist arthritis with spanning plate and carpometacarpal joint arthrodesis compared to non-spanning plate without carpometacarpal arthrodesis
Secondary ID [1] 303009 0
None
Universal Trial Number (UTN)
U1111-1262-6523
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
wrist post traumatic arthritis
 320067 0
wrist osteoarthritis 320068 0
post traumatic arthritis 320385 0
surgery 320805 0
Condition category
Condition code
Musculoskeletal 317997 317997 0 0
Osteoarthritis
Surgery 318286 318286 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised control trial will scrutinise wrist arthrodesis with carpometacarpal joint (CMCJ) fusion using a CMCJ spanning plate compared to wrist arthrodesis without CMCJ fusion with a non-spanning CMCJ plate. The population assessed will be adults with isolated wrist arthritis awaiting total arthrodesis of the wrist. After consent and randomisation they will undergo total wrist arthrodesis with the Synthes DePuy/AO wrist arthrodesis plate (CMCJ spanning plate) with CMCJ fusion or total wrist arthrodesis with the Medartis APTUS Trilock (CMCJ non-spanning plate) without CMCJ fusion. Surgery will be undertaken by a fellowship trained orthopaedic surgeon specialising in hand and wrist surgery. Bone graft from local or other sources will be permitted. The duration of surgery will not differ between treatment and control groups. An observer will ensure that participants are treated according to allocation. The populations will be compared at 1, 2 and 5 years for complications. Secondary outcomes will include assessment of disability with the Disabilities of the Arm Shoulder and Hand (DASH) score, Patient Rate Wrist Evaluation (PRWE) and grip strength.

Control group (CMCJ arthrodesis)
The radiocarpal, intercarpal AND the CMCJ will be prepared for fusion in the group undergoing CMCJ arthrodesis. A CMCJ bridging plate will be applied (Synthes DePuy/AO Wrist fusion plate) from the third metacarpal to the radius as described by the manufacturer’s instructions.

Intervention group (CMCJ sparing)
During surgery the CMCJ will be identified and carefully preserved in the CMCJ sparing arm. After preparing the carpals for fusion, while carefully preserving CMCJ joint and its capsule, a non-spanning wrist fusion plate will be applied according the manufactures description (Medartis AG, Switzerland).
Intervention code [1] 319296 0
Treatment: Surgery
Comparator / control treatment
Control group (CMCJ arthrodesis)
This trial is a comparison of two excepted standards of care in total wrist arthrodesis. Traditionally, total wrist arthrodesis with CMCJ fusion and a bridging plate is described but recent literature supports equivalent outcomes wrist arthrodesis performed with a non-spanning plate without CMCJ arthrodesis. For this reason it is appropriate to describe the CMCJ arthrodesis with spanning plate as the control group.

The radiocarpal, intercarpal AND the CMCJ will be prepared for fusion in the group undergoing CMCJ arthrodesis. A CMCJ bridging plate will be applied (Synthes DePuy/AO Wrist fusion plate) from the third metacarpal to the radius as described by the manufacturer’s instructions.
Control group
Active

Outcomes
Primary outcome [1] 325998 0
Post operative complications will be assessed at 12 weeks by the treating surgeon using a standard form. Complications will also be assessed at year by patient review using a standard form.

Complications are defined to include-
Wound dehiscence
Infection: superficial (treated with antibiotics alone) and deep (requiring surgical debridement and antibiotics
Fracture: in the perioperative period and in the follow up period
Hardware breakage: plate or screw, managed operative or non-operatively
Tendon rupture
Tendon irritation: requiring treatment
Timepoint [1] 325998 0
1 year post index surgery. Ie within 12 months of surgery.
Primary outcome [2] 326024 0
Union
Non-union: recorded radiocarpal, midcarpal and carpometacarpal joint and defined as absence of bridging bony trabeculae with no interval change over 3 months, assessed by computer tomographic (CT) scan.
Timepoint [2] 326024 0
Union (assessed with 6 months of index procedure) - routine assessment of radiocarpal, midcarpal and carpometacarpal joint by compter tomographic (CT) scan.
Secondary outcome [1] 389811 0
Disabilities of Arm, Shoulder and Hand (DASH) score to assess global upper limb function
Timepoint [1] 389811 0
1,2, 5 years post operatively
Secondary outcome [2] 389812 0
Patient Rated Wrist Evaluation (PRWE) to assess wrist function and pain
Timepoint [2] 389812 0
1,2, 5 years post operatively
Secondary outcome [3] 389813 0
Grip strength will be using a Jamar dynamometer
Timepoint [3] 389813 0
1,2, 5 years post operatively
Secondary outcome [4] 389814 0
Late complications (> 12 months) will be assess by patient review and include
- Complications as previously defined
- ie developed of pain, implant breakage, need for additional operation
Timepoint [4] 389814 0
2 and 5 years post operatively

Eligibility
Key inclusion criteria
This study will include English speaking, non-institutionalized individuals aged > 18 years deemed suitable for total wrist arthrodesis by their surgeon, with non-inflammatory indications for surgery including:
SNAC (Scaphoid non-union advanced collapse)
SLAC (Scapholunate ligament advanced collapse)
Keinbock’s disease/Lunate avascular necrosis
Preiser’s disease/Scaphoid avascular necrosis
Wrist osteoarthritis
Post traumatic arthritis
Failed partial fusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from this study if:
Lack ability to consent for participation (cognitive capacity or English proficiency)
Lack ability to report patient outcomes measures (cognitive capacity or English proficiency)
Have an inflammatory arthropathy (i.e., Rheumatoid arthritis)
Have pre-existing upper ipsilateral or contralateral limb pain or dysfunction
Brain, nerve or muscle dysfunction (CVA, plexus injury, peripheral nerve injury, spasm or contracture)
Tumour of the wrist (giant cell or other)
Wrist arthroplasty that will be revised to arthrodesis
Planned to undergo or have undergone bilateral wrist arthrodesis

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 performed using a computer randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used. Surgeons will be stratified.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
Nagy et al 2002 reported 20 non unions in 47 attempted wrist fusions with attempted CMCJ fusion and 1 incidence of CMCJ pain in 34 wrist fusion in which the CMCJ was spanned. Berling et al 2015 reported 13 complications in 67 spanned wrist fusions and 7 complications in 55 wrist fusions with attempted CMCJ fusion. Rancy et al 2018 reported 3 complications in 11 spanned wrist fusions and 3 complications in 15 wrist fusions performed with a non-spanning T-plate. Based on these numbers and assuming alpha = 0.05, beta = 0.2, the participants need for this study are 26, 940 and 1062 respectively. Based on these estimates we expect that 100 wrists will be needed to adequately discriminate between these two techniques in terms of complications.
We previously reported a DASH of 19 and PRWE of 13 of in a series of 77 wrist fusions in which the CMCJ was fused. Hernekamp et al 2020 reported a DASH score of 40.5 in 10 non-spanning wrist fusions, compared to 42.8 in 10 spanning wrist fusions. Rancy et 2018 reported of PRWE of 25.9 in non-spanning wrist fusion. Based on the fact that many studies have been unable to separate CMCJ fusion, non-spanning and spanning using these instruments, and that the MCID for the DASH is estimated as ranging between 10 and 11 (Angst et al 2011; Franchignoni et al., 2014; Schmitt et al 2004), and 10-14 points for PRWE (Arora et al., 2009; Walenkamp et al., 2015), we think it will be difficult for us to show a difference between these groups with only 100 participants. We will however have collect DASH and PRWE as they have been used in a number of papers, including our own series, to assess outcome following wrist arthrodesis(Owen et al., 2016).
Analysis
Data will be analysed on an intention to treat basis.
Descriptive statistical analysis will be performed on patient demographic factors and comorbidities. Randomisation will ensure that both groups are equivalent in terms of comorbidities and demographic factors. A post hoc analysis of the treatment and control group will be performed to assess and confirm this.
Complications will be tabulated and the incidence in each group compared.
Pre-operative and post-operative grip strength, DASH and PRWE will be analysed accordingly. Comparison will be made between preoperative data and post-operative data and between different techniques of wrist fusion.
A statistician will be involved if required.
Cross over
Although the procedures are very similar, it is possible that crossover may occur from the non-spanning method to the spanning technique with CMCJ fusion. This could occur because of the development of pain at the CMCJ due to additional loading or progression of arthritis. Analysis of data will be on an intention to treat basis regardless of final treatment, but the rate of crossover will be described.
Stopping/Interim analysis
There is no plan to perform an interim analysis or stop the study, as it is anticipated that the difference in the treatment and control arms will be small. Both methods assessed are widely used and there is no evidence to suggest superiority of one method over another. All adverse events will be recorded and reported.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/03/2029
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 18224 0
The Canberra Hospital - Garran
Recruitment hospital [2] 18225 0
Calvary John James Hospital - Deakin
Recruitment hospital [3] 18226 0
Calvary Private Hospital ACT - Bruce
Recruitment hospital [4] 18227 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [5] 18228 0
National Capital Private Hospital - Garran
Recruitment postcode(s) [1] 32284 0
2605 - Garran
Recruitment postcode(s) [2] 32285 0
2600 - Deakin
Recruitment postcode(s) [3] 32286 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 307420 0
Other Collaborative groups
Name [1] 307420 0
Trauma and orthopaedic research unit
Country [1] 307420 0
Australia
Primary sponsor type
Hospital
Name
Trauma and Orthopaedic Research Unit Canberra Hospital
Address
Trauma and orthopaedic research unit
Canberra Hospital
Yamba Drive
GARRAN
2605
ACT
Country
Australia
Secondary sponsor category [1] 308086 0
None
Name [1] 308086 0
Address [1] 308086 0
Country [1] 308086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307502 0
ACT Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 307502 0
Ethics committee country [1] 307502 0
Australia
Date submitted for ethics approval [1] 307502 0
06/08/2020
Approval date [1] 307502 0
09/12/2020
Ethics approval number [1] 307502 0
2020.ETH.00207
Ethics committee name [2] 307519 0
Calvary Hospital Bruce, Human Research Ethics Committee
Ethics committee address [2] 307519 0
Ethics committee country [2] 307519 0
Australia
Date submitted for ethics approval [2] 307519 0
14/12/2020
Approval date [2] 307519 0
16/12/2020
Ethics approval number [2] 307519 0
2020.ETH.00207

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

Contacts
Principal investigator
Name 107462 0
Dr David Owen
Address 107462 0
Trauma and Orthopaedic Unit
Canberra Hospital
Yamba Drive
GARRAN
ACT 2605
Country 107462 0
Australia
Phone 107462 0
+61449247535
Fax 107462 0
Email 107462 0
[email protected]
Contact person for public queries
Name 107463 0
Diane Perimann
Address 107463 0
Trauma and Orthopaedic Unit
Canberra Hospital
Yamba Drive
GARRAN
ACT 2605
Country 107463 0
Australia
Phone 107463 0
+61 2 5124 3701
Fax 107463 0
Email 107463 0
[email protected]
Contact person for scientific queries
Name 107464 0
David Owen
Address 107464 0
Trauma and Orthopaedic Unit
Canberra Hospital
Yamba Drive
GARRAN
ACT 2605
Country 107464 0
Australia
Phone 107464 0
+61 2 5124 3701
Fax 107464 0
Email 107464 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?
After publication, all participant de-identified data will be shared. We plan to include this data as an appendix of publication of the results.
When will data be available (start and end dates)?
Data will be available at the time of final publication as above.
Available to whom?
Raw, de-identified data will be publicly available as an appendix to the final publication.
Available for what types of analyses?
Data will be available to anyone who would like to undertake further analysis.
How or where can data be obtained?
At publication, as an appendix.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10060Study protocolWe plan to publish this protocol.   381101-(Uploaded-20-01-2021-21-02-29)-Study-related document.docx
10064Informed consent form    381101-(Uploaded-16-12-2020-13-51-11)-Study-related document.docx
10065Ethical approval    This is the Canberra Hospital approval. 381101-(Uploaded-16-02-2021-21-17-51)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTotal wrist arthrodesis with and without arthrodesis of the carpoMetacarpal joint (WAWWAM): study protocol.2021https://dx.doi.org/10.1186/s12891-021-04644-4
N.B. These documents automatically identified may not have been verified by the study sponsor.