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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] 307762 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total knee replacement (TKR) surgery 327337 0
Condition category
Condition code
Musculoskeletal 324466 324466 0 0
Osteoarthritis
Surgery 324518 324518 0 0
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] 324225 0
Treatment: Devices
Intervention code [2] 324275 0
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] 332275 0
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] 332275 0
1-year post-surgery
Primary outcome [2] 332319 0
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] 332319 0
1-year post-surgery
Secondary outcome [1] 412785 0
Change in Knee injury and Osteoarthritis Outcome Score (KOOS) 12-item short form and patellofemoral subscales upon discharge from hospital.
Timepoint [1] 412785 0
6, 26 and 52 weeks and at 5 years post-surgery.
Secondary outcome [2] 412922 0
Patient reported satisfaction with TKR and global improvement in outcome assessed using United Kingdom Patient Reported Outcome Measures UK PROM program (Composite).
Timepoint [2] 412922 0
6, 26 and 52 weeks and at 5 years post-surgery ..
Secondary outcome [3] 412924 0
Change in restoration of neutral mechanical limb alignment and component orientation assessed with low-dose CT scan measurement (Composite) .
Timepoint [3] 412924 0
6-months post-surgery.
Secondary outcome [4] 412925 0
Change in end-range knee flexion and extension upon hospital discharge assessed with photography measurement.
Timepoint [4] 412925 0
6, 26 and 52 weeks and at 5 years post surgery.
Secondary outcome [5] 413178 0
Minimal important difference in OKSs.
Timepoint [5] 413178 0
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?
No
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] 22976 0
Nepean Private Hospital - Kingswood
Recruitment postcode(s) [1] 38283 0
2474 - Kingswood

Funding & Sponsors
Funding source category [1] 312027 0
Hospital
Name [1] 312027 0
Department of Orthopaedic Surgery, Nepean Private Hospital, Sydney University
Country [1] 312027 0
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] 313559 0
None
Name [1] 313559 0
Address [1] 313559 0
Country [1] 313559 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311447 0
Nepean Blue Mountains Local Health District HREC
Ethics committee address [1] 311447 0
Ethics committee country [1] 311447 0
Australia
Date submitted for ethics approval [1] 311447 0
Approval date [1] 311447 0
03/06/2022
Ethics approval number [1] 311447 0

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

Contacts
Principal investigator
Name 121126 0
Dr Yasser Khatib
Address 121126 0
Dept of Orthopaedic surgery, Nepean Private Hospital.
2 Hope Street, Penrith NSW 2750
PO Box 949, Penrith NSW 2750
Country 121126 0
Australia
Phone 121126 0
+61 2 47214434
Fax 121126 0
Email 121126 0
yasser@carefirstortho.com.au
Contact person for public queries
Name 121127 0
Femi E. Ayeni
Address 121127 0
Nepean Institute of Academic Surgery,
Nepean Clinical School,
The University of Sydney
62 Derby Street,
Kingswood NSW 2747
Country 121127 0
Australia
Phone 121127 0
+61 2 4734 2609
Fax 121127 0
Email 121127 0
femi.ayeni@sydney.edu.au
Contact person for scientific queries
Name 121128 0
Yasser Khatib
Address 121128 0
Dept of Orthopaedic surgery, Nepean Private Hospital.
2 Hope Street, Penrith NSW 2750
PO Box 949, Penrith NSW 2750
Country 121128 0
Australia
Phone 121128 0
+61 2 47327333
Fax 121128 0
Email 121128 0
yasser@carefirstortho.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive patient data


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16921Ethical approval  yasser@carefirstortho.com.au 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.