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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
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
Secondary ID [1] 301706 0
None
Universal Trial Number (UTN)
U1111-1254-8846
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 318158 0
Partial Knee Arthroplasty 318159 0
Condition category
Condition code
Musculoskeletal 316178 316178 0 0
Osteoarthritis
Surgery 316617 316617 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318009 0
Treatment: Surgery
Intervention code [2] 318010 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324357 0
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.
Timepoint [1] 324357 0
3 months post-intervention procedure
Secondary outcome [1] 384431 0
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
Timepoint [1] 384431 0
6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
Secondary outcome [2] 385611 0
Range of Motion via physical exam assessed using a goniometer.
Timepoint [2] 385611 0
6 weeks, 3 months, and 1 year post-intervention procedure.
Secondary outcome [3] 385612 0
Joint stability via physical exam assessed using a knee state assessment.
Timepoint [3] 385612 0
6 weeks, 3 months, and 1 year post-intervention procedure.
Secondary outcome [4] 385613 0
Pain - Patient reported outcome using the Numeric Pain Rating Scale (NPRS)
Timepoint [4] 385613 0
6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
Secondary outcome [5] 385614 0
Radiographic outcomes - Ahlbäck system for assessing joint space narrowing
Timepoint [5] 385614 0
6 weeks, 3 months, and 1 year post-intervention procedure.
Secondary outcome [6] 385615 0
Patient reported outcome measures - Oxford Knee Score to assess physical knee function.
Timepoint [6] 385615 0
6 weeks, 3 months, 1 year and 2 years post-intervention procedure.
Secondary outcome [7] 386798 0
Patient reported outcome measures - Knee Injury and Osteoarthritis Outcome Score (KOOS-12) to assess knee pain and osteoarthritis function.
Timepoint [7] 386798 0
6 weeks, 3 months, 1 year and 2 years post-intervention procedure.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 17025 0
St John of God Hospital - Bendigo - Bendigo
Recruitment hospital [2] 17026 0
Nepean Private Hospital - Kingswood
Recruitment hospital [3] 17027 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 30694 0
3550 - Bendigo
Recruitment postcode(s) [2] 30695 0
2474 - Kingswood
Recruitment postcode(s) [3] 30696 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 306142 0
Commercial sector/Industry
Name [1] 306142 0
Zimmer Biomet
Country [1] 306142 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
12 Narabang Way, Belrose NSW 2085
Country
Australia
Secondary sponsor category [1] 306612 0
None
Name [1] 306612 0
Address [1] 306612 0
Country [1] 306612 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306359 0
St John of God Healthcare HREC
Ethics committee address [1] 306359 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] 306359 0
Australia
Date submitted for ethics approval [1] 306359 0
13/07/2020
Approval date [1] 306359 0
14/08/2020
Ethics approval number [1] 306359 0
1707

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103610 0
Mr Dugal James
Address 103610 0
Bendigo Orthopaedic Sports Medicine Clinic
176 Barnard Street
Bendigo, Victoria 3550
Country 103610 0
Australia
Phone 103610 0
+61 3 5442 5288
Fax 103610 0
Email 103610 0
[email protected]
Contact person for public queries
Name 103611 0
Dugal James
Address 103611 0
Bendigo Orthopaedic Sports Medicine Clinic
176 Barnard Street
Bendigo, Victoria 3550
Country 103611 0
Australia
Phone 103611 0
+61 3 5442 5288
Fax 103611 0
Email 103611 0
[email protected]
Contact person for scientific queries
Name 103612 0
Dugal James
Address 103612 0
Bendigo Orthopaedic Sports Medicine Clinic
176 Barnard Street
Bendigo, Victoria 3550
Country 103612 0
Australia
Phone 103612 0
+61 3 5442 5288
Fax 103612 0
Email 103612 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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


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.