None listed
Conditions
Brief summary
Osteoarthritis (OA) is the most common joint disease of the elderly, with knee OA more common than hip or ankle OA. Primary total knee arthroplasty (TKA) has been used successfully for decades to treat osteoarthritis. While a mechanical alignment (MA) of the prosthesis was initially pursued, this is increasingly being abandoned with the knowledge of the large variability of individual anatomy and knee biomechanics. New techniques involving patient-specific implantation techniques based on individual cutting guides and robotic-assisted implantation techniques have become more prevalent. While 3D-printed cutting guides are used to plan and perform osseous resections based on the individual bony anatomy, robotic-assisted techniques take into account the ligamentous stress ratios in flexion and extension. The purpose of this study is to determine whether planning based solely on the patient's bony anatomy achieves similar medial and lateral ligamentous tension ratios after total knee arthroplasty as a robotic-assisted technique that implements resections based on ligamentous tension ratios and bony anatomy.
Interventions
The study intervention is total knee arthroplasty. This procedure will be performed once by an experienced orthopaedic knee surgeon in the operating room of a hospital. This procedure involves replacing the distal femoral bone and proximal tibial bone using a knee prosthesis. The procedure takes approximately 90 minutes to two hours.
Two planning techniques will be compared.
The first technique involves pre-operative assessment of the patient anatomy using magnetic resonance imaging and standi
The study intervention is total knee arthroplasty. This procedure will be performed once by an experienced orthopaedic knee surgeon in the operating room of a hospital. This procedure involves replacing the distal femoral bone and proximal tibial bone using a knee prosthesis. The procedure takes approximately 90 minutes to two hours. Two planning techniques will be compared. The first technique involves pre-operative assessment of the patient anatomy using magnetic resonance imaging and standing alignment films. A predicted best fit for the knee replacement components is determined by an engineer and modified by the orthopaedic consultant. The second planning technique is a robotically assisted technique which involves intra-operative mapping of the patient joint surfaces and assessment of ligament tension. Implant position is then determined taking into account both factors. In this study, the planned bony resections from the pre-operative planning will be input into the robotic system to determine the ligament laxity that would have resulted from following the first technique. The robotic assisted technique will be then followed for all patients.
Sponsors
Melbourne Orthopaedic Group
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing primary TKA
Exclusion criteria
(1) Documented refusal of the patient (2) Patients < 18 years of age (3) Inability to comply with required preoperative imaging or MRI requirements, or (4) Medical contraindications to surgery. There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment (5) Pregnancy
Outcome results
None listed