None listed
Conditions
Brief summary
There has been a surge in popularity of so-called "kinematic" alignment in total knee arthroplasty, with a relative lack of evidence to support the claimed benefits. At the same time, knee ligament balance does appear to be a major surgical factor for an optimised patient outcome. For this reason, a study comparing the balance achieved with methods that restore the native coronal plane alignment of the knee compared to mechanical alignment is required to provide further research in this are. The aim of this study is to determine whether ligament balance is more readily achieved by restoring the native coronal plane alignment versus traditional methods. The results of this trial will aim to inform future clinical practice internationally with regard to soft tissue balance and kinematic alignment in total arthroplasty surgery. The hypothesis of this trial is that knees aligned to restore a patient's original anatomy will be more balanced compared to those aligned with a neutral mechanical axis and horizontal joint line.
Interventions
Item 1. Brief name: Initial bony cuts (distal femur and proximal tibia) in routine total knee arthroplasty made according to the kinematic alignment outlined in the surgical plan
Item 2. Why: There has been a recent surge in popularity of kinematic alignment in total knee arthroplasty with a lack of evidence to support the assumed benefits. At the same time, knee ligament balance appears to be a major surgical factor towards an optimized patient outcome. This intervention aims to restore patient
Item 1. Brief name: Initial bony cuts (distal femur and proximal tibia) in routine total knee arthroplasty made according to the kinematic alignment outlined in the surgical plan Item 2. Why: There has been a recent surge in popularity of kinematic alignment in total knee arthroplasty with a lack of evidence to support the assumed benefits. At the same time, knee ligament balance appears to be a major surgical factor towards an optimized patient outcome. This intervention aims to restore patients to their native knee alignment and ligament balance. Item 3. What (materials): All instrumentation involved in the intervention arm are standard of care for routine total knee arthroplasty. Item 4. What (procedure): Initial bony cuts to the distal femur and proximal tibia in the intervention group will be made according to the kinematic alignment in the surgical plan. This plan will include an aim for femoral and tibial component position relative to the mechanical axis of the bones. These cuts will be guided and validated by a full optical surgical navigation system to ensure maximum accuracy. The VERASENSE™ (OrthoSensor, USA) pressure monitoring insert will be used after the proposed alignment has been achieved, but in the intervention group, surgeons will be blinded as to the initial pressure readings. After recording the initial pressure data, surgeons will be able to view the data to allow soft tissue balancing as per standard operating techniques. Any soft tissue or bony adjustments undertaken to achieve this will be recorded. Item 5. Who provided: Two knee arthroplasty surgeons at one hospital will perform all the surgeries. Both surgeons have extensive experience in all aspects of total knee arthroplasty. Item 6. How: The intervention will be provided to patients undergoing routine total knee arthroplasty who have been allocated to the intervention arm preoperatively. Item 7. Where: All interventions will be provided at St George Private Hospital, Kogarah, NSW. Item 8. When and how much: The intervention is intra-operative. Item 9. Tailoring: N/A Item 10. Modifications: N/A Item 11. Adherence/Fidelity (planned): N/A Item 12. Adherence/Fidelity (actual): N/A. The trial has not begun yet.
Sponsors
Dr Samuel Macdessi
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients who meet the indications for primary total knee replacement using the Smith & Nephew posterior-stabilized total knee arthroplasty system Patients diagnosed with idiopathic osteoarthritis, rheumatoid arthritis or post-traumatic osteoarthritis
Exclusion criteria
Revision knee replacement Previous insufficiency fracture Prior Grade 3 posterior cruciate ligament, posterolateral corner or lateral collateral ligament injury Prior medial collateral ligament injury if it still a Grade 2 or Grade 3 laxity Prior femoral, tibial or patellofemoral osteotomies Other prior knee surgery (except arthroscopic meniscectomy or anterior cruciate ligament reconstruction) Ipsilateral foot, ankle or hip arthritis Preoperative range of motion <90 degrees and flexion contracture >20 degrees Pregnant female, or planning on becoming pregnant during study follow-up period Mental condition that may interfere with capacity to fulfil study requirements Inability to provide fully informed consent due to cognitive incapacity or English language deficiency
Outcome results
None listed