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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.

Does personalised soft tissue balance data delivered by the NextAR Navigation System (NextAR) improve outcomes in patients undergoing medially stabilised knee arthroplasty?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001635156
Acronym
NEXT-AR
Enrollment
82
Registered
2019-11-25
Start date
2022-05-02
Completion date
2024-05-31
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 TG

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.

Sponsors

Medacta Australia Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- Patients with end-stage osteoarthritis of the knee suitable for total knee arthroplasty - Aged over 18 years

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026