Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000990224
Ethics application status
Approved
Date submitted
1/06/2018
Date registered
13/06/2018
Date last updated
3/02/2020
Date data sharing statement initially provided
30/10/2018
Date results information initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the ROSA Knee Robot System for patients undergoing a primary total knee replacement - an early evaluation of the ROSA Knee System.
Scientific title
A clinical evaluation of ROSA Knee 1.0 Robotic Total Knee Application used in primary total knee arthroplasty - a pilot study to evaluate the ROSA Knee System applications and performance intra-operatively.
Secondary ID [1] 295063 0
CEA2018-25K
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Joint Disease 308110 0
Condition category
Condition code
Musculoskeletal 307149 307149 0 0
Other muscular and skeletal disorders
Musculoskeletal 307164 307164 0 0
Osteoarthritis
Surgery 307201 307201 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ROSA Knee System is a stereotaxic instrumentation system for total knee replacement surgery. The system is used by the surgeon to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
Intervention code [1] 301396 0
Treatment: Surgery
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306110 0
ROSA Knee System performs as intended assessed using surgeon responses to product development evaluation questions and surgeon experience questions, following using the system intra-operatively.
-surgical workflow
-surgical measures
Timepoint [1] 306110 0
Immediately prior to surgery through to completion of surgery.
Secondary outcome [1] 347602 0
Time efficiencies assessed by time taken to set-up, skin to skin time, and total procedure time using a study-specific questionnaire.
Timepoint [1] 347602 0
Immediately prior to surgery through to completion of surgery.
Secondary outcome [2] 347869 0
Cost efficiencies assessed by total procedure time and total theatre time, and instrument usage and reduction in instrument sterilization, using a study-specific questionnaire..
Timepoint [2] 347869 0
Immediately prior to surgery through to completion of surgery.

Eligibility
Key inclusion criteria
Patient qualifies for a primary total knee arthroplasty based on the investigator’s clinical judgement
Independent of study participation, patient is a candidate for commercially available Persona Total Knee or Vanguard Total Knee or NexGen Total Knee arthroplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has active, local infection or previous intra-articular infection in the affected joint
Insufficient bone stock on femoral or tibial surfaces
Neuropathic arthroplasty
Osteomalacia or any metabolic disorder which may impair bone formation
Severe instability secondary to the absence of collateral ligament integrity
Rheumatoid arthritis accompanied by an ulcer of the skin or history of recurrent breakdown of the skin

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
26/10/2018
Date of last participant enrolment
Anticipated
Actual
2/09/2019
Date of last data collection
Anticipated
Actual
2/09/2019
Sample size
Target
90
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 11054 0
St John of God Hospital - Bendigo - Bendigo
Recruitment hospital [2] 11055 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 12303 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 24497 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 299645 0
Commercial sector/Industry
Name [1] 299645 0
Zimmer Biomet Pty Ltd
Country [1] 299645 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet Pty Ltd
Address
L3, 12 Narabang Way
Belrose NSW 2085
Country
Australia
Secondary sponsor category [1] 298971 0
None
Name [1] 298971 0
Address [1] 298971 0
Country [1] 298971 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300542 0
St John of God Healthcare HREC
Ethics committee address [1] 300542 0
St John of God Health Care Human Research Ethics Committee
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
Ethics committee country [1] 300542 0
Australia
Date submitted for ethics approval [1] 300542 0
08/05/2018
Approval date [1] 300542 0
13/06/2018
Ethics approval number [1] 300542 0

Summary
Brief summary
The study aims to collection information on the performance of the robot system intra-operatively.
Enrolment is eligible candidates undergoing primary Total Knee Arthroplasty using a Persona total knee implant system or Vanguard total knee implant system or NexGen total knee implant system.
There will be three research centres. One surgeon at each centre. Ten participants will be recruited at each centre.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84006 0
Mr Dugal James
Address 84006 0
Bendigo Orthopaedic & Sports Medicine
Barnard Street
Bendigo VIC 3550
Country 84006 0
Australia
Phone 84006 0
+61 3 5442 5288
Fax 84006 0
Email 84006 0
dugal@dugaljames.com.au
Contact person for public queries
Name 84007 0
Mr Dugal James
Address 84007 0
Bendigo Orthopaedic & Sports Medicine
Barnard Street
Bendigo VIC 3550
Country 84007 0
Australia
Phone 84007 0
+61 3 5442 5288
Fax 84007 0
Email 84007 0
dugal@dugaljames.com.au
Contact person for scientific queries
Name 84008 0
Ms Arianne Jolly
Address 84008 0
Zimmer Biomet Pty Ltd
L3, 12 Narabang Way
Belrose NSW 2085
Country 84008 0
Australia
Phone 84008 0
+61 2 9483 5611
Fax 84008 0
Email 84008 0
arianne.jolly@zimmerbiomet.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
summary data only
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary