None listed
Conditions
Brief summary
This is a prospective, multi-centre, randomised, clinical trial to compare the outcomes following two different surgical implant alignment techniques used in total knee replacement surgery. The trial will enrol 102 participants over a 12-month recruitment period between 3 surgeons. The ideal alignment for a total knee replacement (TKR) provides the best outcomes, a stable knee with least pain, best range of motion and overall patient satisfaction and maintains this in the long term. Currently, mechanical alignment is a standard alignment method used to align TKRs. This is an alignment method that places the femoral component (end of the thigh bone) and the tibial component (top of the shin bone) at right angles to the floor when standing, so that the limb forms a straight line. Research has shown that mechanical alignment and the patient’s natural alignment are rarely the same and this is the likely cause for patient discomfort. This led to the development of modified kinematic alignment which looks at the alignment of the two bones that join to the knee, the femur and the tibia. The femur and tibia are aligned on the patient’s own natural axis, rather than the mechanical axis. This is determined by imaging scans such as an x-ray, software, and the surgeon. Most importantly, it places the focus on the patient’s own, natural knee alignment rather than a straight line between the hip and ankle. Study Hypothesis: Patient reported outcomes for robotic modified kinematic total knee replacement using a surgical plan developed using specialist software called iTKR, will be superior to mechanical alignment outcomes. Participants will complete patient reported outcome questionnaires pre-operatively and at 6 months and 2 years post-operatively. Range of motion of the knee will also be measured.
Interventions
This study is a prospective, randomised trial to monitor and compare the outcomes following a primary total knee arthroplasty using two different implant alignment techniques. The one being conventional mechanical alignment, the other being modified kinematic alignment using the iTKR software to produce the surgical plan.
The surgeon undertakes templating from the prescribed long leg x-rays in order to determine the measurement values needed to create the surgical plan. The measurement values
This study is a prospective, randomised trial to monitor and compare the outcomes following a primary total knee arthroplasty using two different implant alignment techniques. The one being conventional mechanical alignment, the other being modified kinematic alignment using the iTKR software to produce the surgical plan. The surgeon undertakes templating from the prescribed long leg x-rays in order to determine the measurement values needed to create the surgical plan. The measurement values are entered into the iTKR website portal along with the unique patient study identifier and a series of questions are answered by the surgeon. The software will then produce a surgical plan based on the measurements and surgeon responses. The surgeon will check the plan against the patient ID before commencing surgery. The surgeon will then use this plan with the robotically assisted navigation system. The surgical duration will be the same as for a routine total knee arthroplasty surgery. All participants will be clinically assessed using standard functional parameters measuring range of movement pre-operatively, 6 months post-operatively and 2 years post-operatively.
Sponsors
Global Orthopaedic Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet the following criteria to be considered eligible to enrol into the study: 1. Be over the age of 18 years; 2. Be capable of understanding the study requirements and of providing informed consent 3. Be eligible for a primary total knee replacement base on history, physical examination and radiological evaluation – 4. Have primary diagnosis of Osteoarthritis of the knee 5. Agree to attend the research centre for the required post-operative assessments and radiological evaluation. 6. Pre-operative varus/valgus angle 15 degrees or less
Exclusion criteria
Participants will be excluded from participating in the study if they meet any of the following exclusion criteria: 1. Not meeting the inclusion criteria. 2. BMI greater than 35 3. Haemoglobin A1c greater than 7 4. History of infection in the involved knee or current systemic infection 5. Previous fracture of the femur, tibia, patella or pelvis 6. Previous osteotomy of the affected knee 7. Previous ACL damage or repair 8. Not medically cleared to undergo a total knee replacement 9. American Society of Anaesthesiologists rating of 4 or greater 10. Life expectancy of less than 6 months from all causes 11. Workers Compensation patient 12. Preoperative knee in greater than 15 degrees of varus or valgus 13. Ligamentous laxity of the knee requiring a higher level constrained prosthesis
Outcome results
None listed