RecruitingACTRN12621000205831

RASKAL: Robotic-assisted surgery and kinematic alignment in total knee arthroplasty

RASKAL: Robotic-assisted surgery and kinematic alignment in total knee arthroplasty. A registry-nested, multi-centre, 2 x 2 factorial randomised trial of clinical, functional, radiographic and survivorship outcomes

Sponsor

Australian Orthopaedic Association National Joint Replacement Registry

Enrollment

300 participants

Start Date

May 17, 2021

Study Type

Interventional

Conditions

End Stage Arthritis Osteoarthritis Total Knee Replacement

Summary

Over the last few years, there has been a significant increase in the use of robotic-assisted surgery (RAS) in total knee arthroplasty (TKA), as well as increasing adoption of kinematic alignment (KA) strategies. Given the significant expenditure required for robotic-assisted surgery, along with increasing use of kinematic alignment, rigorous clinical evidence is required to guide practice in these areas. The RASKAL study will be assessing patient outcomes by comparing 2 different assistance (Robotic- RAS/Computer-CAS) and alignment (Kinetic -KA/Mechanical-MA) techniques currently used in Total Knee Arthroplasty in Australia. The study will be assessing patient outcomes by comparing 2 different assistance (Robotic- RAS/Computer-CAS) and alignment (Kinetic -KA/Mechanical-MA) techniques currently used in Total Knee Arthroplasty in Australia. The primary aim of the study is to determine if there is a difference between the groups measured by Patient Reported Outcome Measures (PROMs) over 2 years. The study will be nested within the AOANJRR utilising the RAPID (Real time Automated Platform for Integrated Data capture) system and will be conducted in around 10 sites (across NSW and WA) with 15 surgeons.

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study, called RASKAL, is looking at two important questions in knee replacement surgery: does using a robot to assist the surgeon lead to better outcomes than using a computer, and does aligning the new knee joint to match your body's natural movement (kinematic alignment) work better than the traditional straight-line approach (mechanical alignment)? Knee replacements are one of the most common major surgeries in Australia, and there is growing interest in both robotic assistance and kinematic alignment, but solid evidence comparing them is still limited. If you are aged 40 to 80, have been diagnosed with osteoarthritis in one knee, and your surgeon recommends a knee replacement using the Stryker Triathlon implant, you may be eligible. Surgeons across around 10 sites in NSW and WA are taking part. You would be randomly assigned to one of four groups combining the two types of assistance and alignment techniques. After your surgery, you will be asked to complete questionnaires about your pain, function, and quality of life over two years. This research will help surgeons and patients make more informed decisions about which approach gives the best results for people having a knee replacement.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All 4 interventions listed below are approved and commonly used surgical techniques in Australia. Participating surgeons are formally trained and have performed a minimum of 10 TKA procedures in each

All 4 interventions listed below are approved and commonly used surgical techniques in Australia. Participating surgeons are formally trained and have performed a minimum of 10 TKA procedures in each intervention group. Participants will be randomly allocated to one of the four interventional procedure listed. Each procedure will take approximately 60 - 120 minutes. 1. robotic-assisted TKA with kinematic knee alignment (RAS-KA group) using MAKO Robotic Platform. This procedure is the intervention arm for both surgical assistance and alignment groups. Alignment in this group is set intraoperatively by the MAKO Robot Product Specialists and surgeon using matched resections. The only adjustments to the matched resections start plan is if restricted KA boundaries are exceeded. Intra-operative gap balancing will then be performed with the aim to achieve symmetrical gap balance. Any adjustments to the original KA plan in order to achieve balanced gaps will be recorded. Adjustments must not exceed the restricted safe zone boundaries. Any further bone cuts or soft tissue releases to achieve balance is permitted and will be recorded. 2. robotic-assisted TKA with mechanical knee alignment (RAS-MA group) MAKO Robotic Platform. This procedure is the second control group for comparison against KA. In addition, this factorial group will test whether RAS haptic boundaries reduce postoperative analgesia consumption and improves early patient outcomes due to a reduction in soft tissue trauma compared to CAS-MA. Preoperative planning software will be set to the MA alignment targets and will be performed with MA resection angles. Only soft tissue balancing is permitted and will be recorded. In order to ensure MA is maintained, no adjustments to alignment are permitted. 3. computer-assisted TKA with kinematic knee alignment (CAS-KA group) using Stryker Precision 3 Navigation System. This procedure represents a restricted boundary KA technique. The surgeon will be provided with a preoperative KA plan, as CAS is considered an imageless (non-CT derived) technique and will be performed with resection angles based on the KA plan. Any further bone cuts or soft tissue releases to achieve balance is permitted and will be recorded. 4. computer-assisted TKA with mechanical knee alignment (CAS-MA group) using Stryker Precision 3 Navigation System. This procedure serves as the control for both factorial groups and will be performed with MA resection angles. Soft tissue balancing is permitted and will be recorded. In order to ensure MA is maintained, no adjustments to alignment are permitted. Measurements, alignments and any protocol deviations will be recorded by the local study coordinator.