ANZCTR - Registration

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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]

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

wrist osteoarthritis

post traumatic arthritis

surgery

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

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]

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]

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]

1 year post index surgery. Ie within 12 months of surgery.

Primary outcome [2]

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]

Union (assessed with 6 months of index procedure) - routine assessment of radiocarpal, midcarpal and carpometacarpal joint by compter tomographic (CT) scan.

Secondary outcome [1]

Disabilities of Arm, Shoulder and Hand (DASH) score to assess global upper limb function

Timepoint [1]

1,2, 5 years post operatively

Secondary outcome [2]

Patient Rated Wrist Evaluation (PRWE) to assess wrist function and pain

Timepoint [2]

1,2, 5 years post operatively

Secondary outcome [3]

Grip strength will be using a Jamar dynamometer

Timepoint [3]

1,2, 5 years post operatively

Secondary outcome [4]

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]

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?

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]

The Canberra Hospital - Garran

Recruitment hospital [2]

Calvary John James Hospital - Deakin

Recruitment hospital [3]

Calvary Private Hospital ACT - Bruce

Recruitment hospital [4]

Calvary Public Hospital ACT - Bruce

Recruitment hospital [5]

National Capital Private Hospital - Garran

Recruitment postcode(s) [1]

2605 - Garran

Recruitment postcode(s) [2]

2600 - Deakin

Recruitment postcode(s) [3]

2617 - Bruce

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Trauma and orthopaedic research unit

Address [1]

Trauma and orthopaedic research unit
Canberra Hospital
Yamba Drive
GARRAN
2605
ACT

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

ACT Health Human Research Ethics Committee (HREC)

Ethics committee address [1]

Research Ethics and Governance
Centre for Health & Medical Research
ACT Health Directorate
Canberra Hospital
GARRAN, ACT 
2605

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/08/2020

Approval date [1]

09/12/2020

Ethics approval number [1]

2020.ETH.00207

Ethics committee name [2]

Calvary Hospital Bruce, Human Research Ethics Committee

Ethics committee address [2]

Public Hospital Bruce
Cnr Belconnen Way & Haydon Drive Bruce ACT 2617
PO Box 254 Jamison Centre ACT 2614

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/12/2020

Approval date [2]

16/12/2020

Ethics approval number [2]

2020.ETH.00207

Summary

Brief summary

The purpose is to determine if it is better (or worse) to include the carpometacarpal joint in total wrist fusion. 

The carpometacarpal joint (CMC) doesn’t move much in a normal wrist. It is located at the base of the metacarpals which are bones located between the wrist bones and fingers.

If the carpometacarpal joint is fused in total wrist fusion, the third carpometacarpal joint (at the base of the long finger metacarpal) is usually fused. Sometimes the second carpometacarpal joint (base of the index finger) is fused if a slightly different position of the wrist is required.

We do not yet know if fusing the CMC joint (or not) during wrist fusion leads to better patient outcomes. Currently, some surgeons prefer to fuse this joint as they think it may become painful later and that motion at this joint may cause the metal plates used in wrist fusion to break. 

Previous research on this question has shown there is no difference in outcome in patients who have or have not have this joint fused during total wrist fusion. However, these studies were small and were not properly designed to answer this question. For this reason, we would like to complete a properly designed study to determine what approach leads to the best outcomes. 

We seek to compared the two 'gold standards' of wrist arthrodesis in a randomised way - wrist fusion with inclusion of the CMCJ with a plate that goes across this joint to wrist fusion without CMCJ fusion with a plate that does not cross this joint. 

The results of this study will inform future patients and surgeons of the best option.

Trial website

None

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Owen

Address

Trauma and Orthopaedic Unit
Canberra Hospital
Yamba Drive
GARRAN
ACT 2605

Country

Australia

Phone

+61449247535

Fax

david.owen@anu.edu.au

Contact person for public queries

Name

Diane Perimann

Address

Trauma and Orthopaedic Unit
Canberra Hospital
Yamba Drive
GARRAN
ACT 2605

Country

Australia

Phone

+61 2 5124 3701

Fax

diana.perriman@anu.edu.au

Contact person for scientific queries

Name

David Owen

Address

Trauma and Orthopaedic Unit
Canberra Hospital
Yamba Drive
GARRAN
ACT 2605

Country

Australia

Phone

+61 2 5124 3701

Fax

david.owen@anu.edu.au

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.	Type	Citation	Other Details	Attachment
10060	Study protocol	We plan to publish this protocol.		381101-(Uploaded-20-01-2021-21-02-29)-Study-related document.docx
10064	Informed consent form			381101-(Uploaded-16-12-2020-13-51-11)-Study-related document.docx
10065	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Total wrist arthrodesis with and without arthrodesis of the carpoMetacarpal joint (WAWWAM): study protocol.	2021	https://dx.doi.org/10.1186/s12891-021-04644-4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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