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Trial registered on ANZCTR


Registration number
ACTRN12619001635156p
Ethics application status
Not yet submitted
Date submitted
12/11/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Determining the clinical utility of the NextAR navigation system in providing soft tissue balance pattern data during total knee replacement surgery, to enable prosthesis implants to resemble more native knee alignment and thereby improve patient outcomes.
Scientific title
Does personalised soft tissue balance data delivered by the NextAR Navigation System
(NextAR) improve outcomes in patients undergoing medially stabilised knee arthroplasty?
Secondary ID [1] 299786 0
P02.022.01
Universal Trial Number (UTN)
Trial acronym
NEXT-AR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 315153 0
Condition category
Condition code
Musculoskeletal 313472 313472 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Total Knee Replacement (TKR) procedure is a standard of care intervention to treat severe degenerative knee joint disease conditions (such as osteoarthritis). All patients being considered for enrollment in this trial will be undergoing TKR as per usual treatment management plans provided by their referring clinician. Surgery will take place in accredited public hospital surgical theatre by qualified orthopaedic surgeons.
As part of the TKR procedure, the patients will be implanted with a TGA Approved artificial knee joint prosthesis. The prosthesis will be fitted to the patient using custom 3D printed Patient-Specific Guides (PSGs) that are placed on the bone to guide the surgeon to make accurate bone resections in order to accommodate the knee prosthesis. The custom 3D printed PSGs are used routinely and are a well-accepted method of performing TKR surgery in Australia.
For this trial, one group of patients will undergo routine TKR surgery with the custom 3D printed PSGs, another group of patients will undergo TKR surgery using the 3D printed PSGs and additionally their collateral ligaments will be assessed intra-operatively using a Computer-Aided Surgery (CAS) Navigation system (NEXT-AR). The NEXT-AR Navigation system comprises of infrared cameras that are able to track the movement of the knee joint throughout surgery and can provide the surgeon with data about the state of the collateral ligaments of that patient. This ligament data can inform the surgeon about the optimal positioning of the knee prosthesis to potentially improve the patient satisfaction and knee kinematics post-operatively.
This trial will assess if there are any differences in patient satisfaction or knee kinematics between the two patient groups.
Intervention code [1] 316042 0
Treatment: Devices
Comparator / control treatment
Comparator group will include surgeons who will perform routine total knee replacement (TKR) surgical procedures (including using custom 3D printed Patient Specific Guides) without the additional collateral ligament data provided by the NEXT-AR system. This is reflective of standard of care practice for TKR procedures.
Control group
Active

Outcomes
Primary outcome [1] 321947 0
Two-year self-reported joint replacement awareness scores as measured using The Forgotten Joint Score Questionnaire.
Timepoint [1] 321947 0
Two-years post-surgery
Secondary outcome [1] 376767 0
To assess clinical outcomes as measured by scores obtained following the completion of the Oxford Knee Questionnaire at two-years.
Timepoint [1] 376767 0
Two years post-surgery
Secondary outcome [2] 377041 0
To assess clinical outcomes as measured by scores obtained following the completion of the International Knee Documentation Committee (IKDC) Questionnaire at two-years.
Timepoint [2] 377041 0
Two-years post-surgery.
Secondary outcome [3] 377042 0
To assess clinical outcomes as measured by scores obtained following the completion of the EQ-5D Questionnaire at two-years.
Timepoint [3] 377042 0
Two-years post-surgery

Eligibility
Key inclusion criteria
- Patients with end-stage osteoarthritis of the knee suitable for total knee arthroplasty
- Aged over 18 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients unsuitable for total knee replacement due to chronic infection, medical disease, inability to consent, inability to attend post-operative follow-up appointments, significant psychiatric issues, substance abuse issues.
- Previous reconstructive/fracture/arthroplasty surgery on affected knee
-Active inflammation arthropathy
- Significant extra articular deformity
- Morbidly Obese (BMI>40)
- Pregnant women

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)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 15141 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 15142 0
Rockingham General Hospital - Cooloongup
Recruitment postcode(s) [1] 28435 0
6160 - Fremantle
Recruitment postcode(s) [2] 28436 0
6168 - Cooloongup

Funding & Sponsors
Funding source category [1] 304248 0
Commercial sector/Industry
Name [1] 304248 0
Medacta Australia Pty Ltd
Address [1] 304248 0
Unit A1, 16 Mars Road
Lane Cove
NSW 2066
Country [1] 304248 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Unit A1, 16 Mars Road
Lane Cove
NSW 2066
Country
Australia
Secondary sponsor category [1] 304498 0
None
Name [1] 304498 0
Address [1] 304498 0
Country [1] 304498 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304705 0
South Metropolitan Health Service
Ethics committee address [1] 304705 0
St John of God Hospital
14 Barry Marshall Parade
Murdoch, WA 6150
Ethics committee country [1] 304705 0
Australia
Date submitted for ethics approval [1] 304705 0
26/11/2019
Approval date [1] 304705 0
Ethics approval number [1] 304705 0

Summary
Brief summary
The Total Knee Replacement (TKR) procedure is a standard of care intervention to treat severe degenerative knee joint disease conditions (such as osteoarthritis). All patients being considered for enrollment in this trial will be undergoing TKR as per usual treatment management plans. The NEXT-AR Navigation system comprises of infrared cameras that are able to track the movement of the knee joint throughout surgery and can provide the surgeon with data about the state of the collateral ligaments of that patient. This ligament data can inform the surgeon about the optimal positioning of the knee prosthesis to potentially improve the patient satisfaction and knee kinematics post-operatively. The hypothesis for this investigation is that NEXT-AR Navigation system data is able to reproduce soft tissue balance patterns and native knee function following prosthesis implantation and thereby improve patient outcomes and satisfaction post-surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97938 0
Dr Ben Jeffcote
Address 97938 0
Western Orthopaedic Clinic
Suite 13, Wexford Medical Centre
3 Barry Marshall Parade
Murdoch, WA, 6150
Country 97938 0
Australia
Phone 97938 0
+61 8 9431 2793
Fax 97938 0
Email 97938 0
ben@wocwa.com
Contact person for public queries
Name 97939 0
Dr Ben Jeffcote
Address 97939 0
Western Orthopaedic Clinic
Suite 13, Wexford Medical Centre
3 Barry Marshall Parade
Murdoch, WA, 6150
Country 97939 0
Australia
Phone 97939 0
+61 8 9431 2793
Fax 97939 0
Email 97939 0
ben@wocwa.com
Contact person for scientific queries
Name 97940 0
Dr Victoria Dokic
Address 97940 0
Medacta Australia Pty Ltd
Unit A1, 16 Mars Road
Lane Cove, NSW, 2066
Country 97940 0
Australia
Phone 97940 0
+61 1300 631 790
Fax 97940 0
Email 97940 0
victoria.dokic@medacta.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
To maintain patient confidentiality
What supporting documents are/will be available?
No other documents available
Summary results
No Results