ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001169730

Ethics application status

Approved

Date submitted

16/08/2022

Date registered

26/08/2022

Date last updated

26/08/2022

Date data sharing statement initially provided

26/08/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Robotic assisted vs instrumented total knee replacement (TKR): a single-blind randomised controlled clinical trial.

Scientific title

Robotic Surgical assisted (ROSA) vs instrumented total knee replacement (TKR): a single-blind randomised controlled clinical trial assessing the effect of TKR-ROSA and TKR-Jigs on patient-reported index knee pain and function in the operated joint using the Oxford Knee Score (OKS) at 52 weeks.

Secondary ID [1]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Total knee replacement (TKR) surgery

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In this single-site, multi-surgeon trial, 100 people (50 in each arm) with knee osteoarthritis will be randomized to undergo unilateral total knee replacement (TKR) surgery at Nepean Private Hospital (NPH) either with the assistance of a robotic arm (ROSA) (TKR-ROSA) or with the conventional method of using standard company manufactured instruments (jigs) (TKR-Jigs).
Nepean Private Hospital is a high-volume arthroplasty centre and participating surgeons are experienced with subspeciality knee arthroplasty training and at least eight years of post-fellowship experience. Surgeons participating in this study already routinely use TKR ROSA.
The procedure time for TKR jigs and TKR ROSA are no different, 60-120mins.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

The surgeon will use the standard company manufactured instruments (jigs) (TKR-Jigs) To perform the routine bone cuts required during the total knee replacement surgery in the control group, The procedure time for TKR jigs and TKR ROSA are no different, 60-120mins.

Control group

Active

Outcomes

Primary outcome [1]

The primary aim is to determine if TKR-ROSA compared to TKR-Jigs yields at least a minimal important difference of 5 points, assessed using the oxford Knee Score (OKS).

Timepoint [1]

1-year post-surgery

Primary outcome [2]

We will use the approved Nepean Blue Mountain local Health District Serious Adverse Event (SAE) Form to report any complication. This form is readily available (SAE form NBMLHD Research Ethics) and approved be the ethics to be used for this study,
All safety events will be reported at quarterly Nepean Private Hospital orthopaedic department mortality and morbidity meetings as well .

We will also report any adverse events particularly related to the use of the ROSA robotic arm, which include:
Pin site fracture will be assessed using low-dose CT scan

Robotic arm failure (technical errors) requiring conversion to conventional jig- guided surgery. Although, no known technical failure has been reported with ROSA. Data regarding robotic arm failure requiring conversion to conventional jig-guided surgery will be properly documented and extracted from the surgeon operation notes .

Contamination of surgical drapes related to the use of the ROSA robotic arm assessed by SWAB for microscopy and culture.

Timepoint [2]

1-year post-surgery

Secondary outcome [1]

Change in Knee injury and Osteoarthritis Outcome Score (KOOS) 12-item short form and patellofemoral subscales upon discharge from hospital.

Timepoint [1]

6, 26 and 52 weeks and at 5 years post-surgery.

Secondary outcome [2]

Patient reported satisfaction with TKR and global improvement in outcome assessed using United Kingdom Patient Reported Outcome Measures UK PROM program (Composite).

Timepoint [2]

6, 26 and 52 weeks and at 5 years post-surgery ..

Secondary outcome [3]

Change in restoration of neutral mechanical limb alignment and component orientation assessed with low-dose CT scan measurement (Composite) .

Timepoint [3]

6-months post-surgery.

Secondary outcome [4]

Change in end-range knee flexion and extension upon hospital discharge assessed with photography measurement.

Timepoint [4]

6, 26 and 52 weeks and at 5 years post surgery.

Secondary outcome [5]

Minimal important difference in OKSs.

Timepoint [5]

6weeks, and 26weeks and 5yrs post-surgery.

Eligibility

Key inclusion criteria

Population
The study population will include individuals aged greater than or equal to 18 years presenting to participating surgeons for TKR due to knee osteoarthritis (OA).

Inclusion criteria
• Primary TKR surgery secondary to OA
• Able to provide informed consent in English

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria
• Simultaneous bilateral TKR or planned sequential TKR within 6 months of each other.

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

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

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/09/2022

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

Recruitment hospital [1]

Nepean Private Hospital - Kingswood

Recruitment postcode(s) [1]

2474 - Kingswood

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Orthopaedic Surgery, Nepean Private Hospital, Sydney University

Address [1]

Department of Orthopaedic Surgery, Nepean Private Hospital, Sydney University

1-9 Barber Ave, Kingswood NSW 2747

Country [1]

Australia

Primary sponsor type

Hospital

Name

Healthscope Australia

Address

Nepean Private Hospital

1-9 Barber Ave, Kingswood NSW 2747

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Nepean Blue Mountains Local Health District HREC

Ethics committee address [1]

Level 5, South Block, Nepean Hospital
PO BOX 63, Penrith NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/06/2022

Ethics approval number [1]

Summary

Brief summary

The purpose of this study is to assess if the use of a robotic arm during TKR surgery results in better patient outcomes compared to the conventional method of using company instruments (jigs). 
In recent years there have been many technological advancements to help surgeons be more accurate in how they put in the components during TKR. The most recent advancement is the development of a robotic arm (ROSA) that assists the surgeon in performing the bony cuts required during surgery before putting in the components of the TKR. 
Traditionally, this part of the procedure has been performed with the help of company instruments called jigs. While the accuracy of component implantation may be better with the use of the robotic arm, we still do not know if the use of the robotic arm means better patient outcomes compared to the standard method of using company instruments (jigs) in TKR.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Yasser Khatib

Address

Dept of Orthopaedic surgery, Nepean Private Hospital.
2 Hope Street, Penrith NSW 2750
PO Box 949, Penrith NSW 2750

Country

Australia

Phone

+61 2 47214434

Fax

[email protected]

Contact person for public queries

Name

Femi E. Ayeni

Address

Nepean Institute of Academic Surgery,
Nepean Clinical School,
The University of Sydney
62 Derby Street,
Kingswood NSW 2747

Country

Australia

Phone

+61 2 4734 2609

Fax

[email protected]

Contact person for scientific queries

Name

Yasser Khatib

Address

Dept of Orthopaedic surgery, Nepean Private Hospital.
2 Hope Street, Penrith NSW 2750
PO Box 949, Penrith NSW 2750

Country

Australia

Phone

+61 2 47327333

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Sensitive patient data

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16921	Ethical approval			[email protected]		384517-(Uploaded-15-08-2022-18-27-09)-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

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically