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Trial registered on ANZCTR
Registration number
ACTRN12620001271998
Ethics application status
Approved
Date submitted
7/07/2020
Date registered
25/11/2020
Date last updated
25/11/2020
Date data sharing statement initially provided
25/11/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
A multi-centre, single-arm, prospective, pre-market, pivotal study on robotic instrumentation (ROSA® Partial Knee System) in patients undergoing medial unicompartmental knee arthroplasty
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Scientific title
A multi-centre, single-arm, prospective, pre-market, pivotal study on robotic instrumentation (ROSA® Partial Knee System) implant accuracy in patients undergoing medial unicompartmental knee arthroplasty
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Secondary ID [1]
301706
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None
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Universal Trial Number (UTN)
U1111-1254-8846
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis
318158
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Partial Knee Arthroplasty
318159
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Condition category
Condition code
Musculoskeletal
316178
316178
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0
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Osteoarthritis
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Surgery
316617
316617
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Partial Knee Arthoplasty. Robot-assisted partial knee arthroplasty procedure is anticipated to take 1 hour to complete. A specialist trained orthopaedic surgeon will perform the surgery using the ROSA robot. Data logs from the robot will be used to assess the fidelity to the intervention, along with imaging following the procedure. In addition, patient reported outcomes and clinical assessments will occur at multiple timepoints following the surgery.
All surgeons will be experienced with the prosthesis, and will have 2 hours implantation cadaveric training session led by the Sponsor on the robotic procedure and specific instrumentation required.
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Intervention code [1]
318009
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Treatment: Surgery
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Intervention code [2]
318010
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Treatment: Devices
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Comparator / control treatment
No Control Group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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To evaluate the accuracy of implant position compared to the implemented plan in unicompartmental knee arthroplasty (UKA) performed with a robotic-arm surgical assistant.
This is a composite outcome of the following assessments:
Post-operative radiography: measurements of the implemented surgical plan (ROSA log data) against radiographs assessing the following:
1) Tibial Coronal Angle (Varus/Valgus)
2) Tibial Sagittal Angle (tilt/slope)
3) Femoral Coronal Alignment (reported as degrees from parallel to the tibial cut)
4) Femoral Sagittal Angle (flexion)
5) Thickness of tibial and femoral resection (tibia proximal and femoral distal)
6) Tibial Sagittal Cut (Axial Plane, intraoperative validation only)
7) Tibial horizontal offset from sagittal resection reference landmark
8) Postoperative Hip-Knee-Ankle Angle.
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Assessment method [1]
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Timepoint [1]
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3 months post-intervention procedure
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Secondary outcome [1]
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Patient Safety. Patient Safety will be evaluated based on the standards, and the frequency of adverse events.
Some examples include:
Revision surgery,
Loosening / Osteolysis - radiography, knee state exam
Pain - NRS pain scale
Infection - Clinical Assessment
Osteolysis - x-ray
Fracture or bone perforation - x-ray
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Assessment method [1]
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Timepoint [1]
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6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
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Secondary outcome [2]
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Range of Motion via physical exam assessed using a goniometer.
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Assessment method [2]
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Timepoint [2]
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6 weeks, 3 months, and 1 year post-intervention procedure.
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Secondary outcome [3]
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Joint stability via physical exam assessed using a knee state assessment.
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Assessment method [3]
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Timepoint [3]
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6 weeks, 3 months, and 1 year post-intervention procedure.
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Secondary outcome [4]
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Pain - Patient reported outcome using the Numeric Pain Rating Scale (NPRS)
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Assessment method [4]
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Timepoint [4]
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6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
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Secondary outcome [5]
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Radiographic outcomes - Ahlbäck system for assessing joint space narrowing
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Assessment method [5]
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Timepoint [5]
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6 weeks, 3 months, and 1 year post-intervention procedure.
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Secondary outcome [6]
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Patient reported outcome measures - Oxford Knee Score to assess physical knee function.
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Assessment method [6]
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Timepoint [6]
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6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
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Secondary outcome [7]
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Patient reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS-12) to assess knee pain and osteoarthritis function.
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Assessment method [7]
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Timepoint [7]
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6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
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Eligibility
Key inclusion criteria
1) Body mass index greater than or equal to 40 kg/m2
2) Patient qualifies for primary UKA for isolated medial compartment osteoarthritis based on investigator’s clinical judgement and has an intact ACL.
3) Independent of study participation, patient is a candidate and meets the indications and contraindications for UKA of the medial compartment with the Persona® partial knee system.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Infection, Sepsis, Osteomyelitis
2) Inflammatory or Post-traumatic arthropathy, or any other degenerative joint disease not consistent with osteoarthritis.
3) Prior ACL repair.
4) Varus/Valgus deformity greater than 15 degrees.
5) Orthopaedic procedure or pain management study of any joint within the last or next 6 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/12/2020
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Actual
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Date of last participant enrolment
Anticipated
31/12/2021
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Actual
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Date of last data collection
Anticipated
31/12/2023
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Actual
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Sample size
Target
72
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
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Recruitment hospital [1]
17025
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St John of God Hospital - Bendigo - Bendigo
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Recruitment hospital [2]
17026
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Nepean Private Hospital - Kingswood
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Recruitment hospital [3]
17027
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Hollywood Private Hospital - Nedlands
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Recruitment postcode(s) [1]
30694
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3550 - Bendigo
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Recruitment postcode(s) [2]
30695
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2474 - Kingswood
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Recruitment postcode(s) [3]
30696
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
306142
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Commercial sector/Industry
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Name [1]
306142
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Zimmer Biomet
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Address [1]
306142
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12 Narabang Way, Belrose NSW 2085
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Country [1]
306142
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
Zimmer Biomet
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Address
12 Narabang Way, Belrose NSW 2085
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
306612
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Country [1]
306612
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306359
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St John of God Healthcare HREC
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Ethics committee address [1]
306359
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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
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Ethics committee country [1]
306359
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Australia
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Date submitted for ethics approval [1]
306359
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13/07/2020
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Approval date [1]
306359
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14/08/2020
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Ethics approval number [1]
306359
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1707
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Summary
Brief summary
Robot assisted knee arthroplasty is a relatively recent development intended to assist the surgeons in achieving accurate bone cuts and predictable implant positioning.
This study is investigating the accuracy of robotic surgery in partial knee arthroplasty. This will include the assessment of the intraoperative planned vs. actual component positioning. Also investigated will be the evaluation of safety and efficacy of this system including the assessment of common adverse events, physical exam findings, radiologic results and patient reported outcome measures.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Dugal James
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Address
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Bendigo Orthopaedic Sports Medicine Clinic
176 Barnard Street
Bendigo, Victoria 3550
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Country
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Australia
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Phone
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+61 3 5442 5288
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Fax
103610
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Email
103610
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[email protected]
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Contact person for public queries
Name
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Mr Dugal James
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Address
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Bendigo Orthopaedic Sports Medicine Clinic
176 Barnard Street
Bendigo, Victoria 3550
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Country
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Australia
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Phone
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+61 3 5442 5288
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Fax
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Email
103611
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[email protected]
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Contact person for scientific queries
Name
103612
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Mr Dugal James
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Address
103612
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Bendigo Orthopaedic Sports Medicine Clinic
176 Barnard Street
Bendigo, Victoria 3550
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Country
103612
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Australia
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Phone
103612
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+61 3 5442 5288
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Fax
103612
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Email
103612
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No IPD will be publicly available.
All patient data will be de-identified before being provided to the sponsor.
All publications will share de-identified, aggregated data to protect patient privacy
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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