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The Use of Navigation to Achieve Soft Tissue Balance in Total Knee Arthroplasty – A Randomised Clinical Study

The Use of Navigation to Achieve Soft Tissue Balance in Total Knee Arthroplasty – A Randomised Clinical Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000516785
Enrollment
40
Registered
2013-05-09
Start date
2008-10-08
Completion date
2009-05-06
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

In this clinical study we aim to assess the difference, if any, in intra-operative soft tissue balancing in computer navigated and conventional total knee replacement (TKR). Computer navigated TKRs have been shown to produce better alignment of the components compared to conventional TKR. Whether there is any long term advantage of computer navigated TKR in terms of function and durability and patient satisfaction is as yet not proven. In this prospective, randomised, patient blinded study, we shall measure the ligament balancing in both groups intra-operatively. This will be done using a tensiometer instrument. There is no morbidity associated with the use of this device which gives an instantaneous reading.

Interventions

All patients receive a Triathlon posterior stabilised, fixed bearing total knee replacement (Stryker Orthopedics, Mahwah, NJ) inserted via a standardised medial para-patellar approach. In the navigated group, initial gaps, at 135N of tension provided by the tensiometer, are recorded after the tibial cut at 90 degrees flexion and full extension. The Stryker version 4.0 software is able to calculate the size of the femoral component after registration of the epicondyles and registration of the bon

All patients receive a Triathlon posterior stabilised, fixed bearing total knee replacement (Stryker Orthopedics, Mahwah, NJ) inserted via a standardised medial para-patellar approach. In the navigated group, initial gaps, at 135N of tension provided by the tensiometer, are recorded after the tibial cut at 90 degrees flexion and full extension. The Stryker version 4.0 software is able to calculate the size of the femoral component after registration of the epicondyles and registration of the bony morphology of the anterior and posterior femoral condyles. Based on the initial gap measurements, the surgeon has a number of options to equilibrate the flexion and extension gaps. These include downsizing the femoral prosthesis or modifying the position of the femoral prosthesis in the anteroposterior or proximodistal planes. The software uses algorithms that take a mean value of the registered femoral transepicondylar axis and the registered femoral anteroposterior axis (Whiteside’s line) to determine axial rotation of the femur. The surgeon aims for the femoral bony cut to have a value of 0+/-2 degrees external rotation based on the software measurement. After the femoral cuts, the gaps at 135N are measured again. The surgeon then makes further soft tissue releases as necessary to try and equalise the mediolateral gaps to within 2mm of each other. Final gap measurements (without the trial components in place) are recorded once again at 135N of tension. 135N was chosen as the tension force as it was felt that this level of tension produced sufficient strain to overcome any laxity in the soft tissues to allow reliable measurement of gaps. The duration of this procedure is approximately 80 minutes.

Sponsors

Dr Hugh English
Lead SponsorIndividual

Study design

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

Eligibility

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

Inclusion criteria

all patients presenting for primary total knee replacement

Exclusion criteria

previous bony surgery on the operated knee

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026