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
Australian Orthopaedic Association National Joint Replacement Registry
300 participants
May 17, 2021
Interventional
Conditions
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
Inclusion Criteria2
- All patients suitable for TKA age 40-80 years with a primary diagnosis of osteoarthritis.
- Patients who meet the indications for primary unilateral TKA using the Stryker Triathlon cruciate-retaining TKA system.
Exclusion Criteria11
- Knee flexion < 90 degrees and knee flexion contracture > 15 degrees at preoperative assessment
- Coronal deformity with hip-knee-ankle (HKA) angle > 15 degrees varus and > 10 degrees valgus on standing long-leg radiographs
- Prior grade 3 injury to posterior cruciate ligament, posterolateral corner, lateral collateral ligament or medial collateral ligament
- TKA requiring increased prosthetic stability (posterior-stabilised, constrained condylar, or rotating hinge designs), diaphyseal stems or metal augments
- TKA for causes other than osteoarthritis (inflammatory arthritis, post-traumatic arthritis, tumour or acute fracture)
- Prior contralateral TKA within 6 months of current TKA surgery
- Any prior knee surgery apart from arthroscopic surgery or anterior cruciate ligament reconstruction
- Prior femoral, tibial or patellofemoral osteotomies
- Symptomatic grade 3-4 ipsilateral ankle or hip arthritis
- The participant unable to attend clinical follow-up for a minimum of 2 years
- The participant is unable to provide informed consent (due to cognitive capacity or English proficiency)
Interested in this trial?
Get notified about updates and connect with the research team.
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 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.
Locations(9)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12621000205831