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Assessing the accuracy of bone cuts in total knee arthroplasty using custom patient specific cutting blocks

Assessing the accuracy of bone cuts in total knee arthroplasty using Smith & Nephew Visionaire custom patient specific cutting blocks

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000115932
Enrollment
30
Registered
2011-02-01
Start date
2010-04-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Patient matched instruments use pre-operative MRI and radiographs to produced custom instruments for total knee replacement surgery. We aim to verify the accuracy of these blocks using standard intra-operative navigation with computer assisted surgery, and post-operatively with xray assessment.

Interventions

Patient Matched Instrumentation(PMI) in Total Knee Arthroplasty (TKA). All patients will undergo routine pre-operative assessment as well as an Magnetic Resonance Image (MRI) scan & long leg x-rays which are used to make “Visionaire” patient matched disposable cutting blocks (instruments). The cutting blocks are made from pure ‘nylon 12’ material, and are made as a single use disposable item designed to match perfectly the patients anatomy. At the time of surgery, patients will undergo routine

Patient Matched Instrumentation(PMI) in Total Knee Arthroplasty (TKA). All patients will undergo routine pre-operative assessment as well as an Magnetic Resonance Image (MRI) scan & long leg x-rays which are used to make “Visionaire” patient matched disposable cutting blocks (instruments). The cutting blocks are made from pure ‘nylon 12’ material, and are made as a single use disposable item designed to match perfectly the patients anatomy. At the time of surgery, patients will undergo routine preparation for navigation with computer assisted surgery (CAS) surgery. Instead of manual placement of a standard cutting blocks under navigation, the Visionaire cutting blocks will then be applied and fixed with standard pins. The position of the blocks will then be referenced to the patients anatomy registered on the CAS, and the data recorded. If the position is inadequate, the blocks will be replaced with standard CAS instruments and the surgery proceed as normal. The surgery will take approximately 90 minutes. All patients will be assessed post-operatively with standard radiographs including long leg films to assess alignment and verify component position. These will be done by 12 weeks post-op.

Sponsors

Dr Price Gallie
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

all patients presenting for total knee arthroplasty who are able to have an Magnetic Resonance Image (MRI) scan

Exclusion criteria

patients unable to have an Magnetic Resonance Image(MRI) scan previous major surgery about the knee patients unable to undergo elective surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026