None listed
Conditions
Brief summary
Total Knee Arthroplasty (TKA) is a common interventions administered to treat severe degenerative knee joint disease conditions (such as osteoarthritis). Traditionally, prosthetic joint components have been implanted to be aligned with the mechanical axis of the femur and tibia. This is done in an attempt to restore neutral overall limb alignment and ensure long term implant survival. However, the benefits of this approach has recently been questioned with the introduction of kinematic alignment techniques. The concept of kinematic alignment (KA) aims to position knee implants to match the pre-arthritic anatomy of each individual patient. It is suggested that this will improve soft tissue balancing, reduce the need for ligament releases, and enhance functional outcome following TKA. To date, only one randomized controlled trial (RCT) has been conducted investigating patient outcomes following KA TKR performed with patient-specific guides vs mechanically aligned TKR performed with conventional instruments. This trial demonstrated a substantial benefit in post-operative pain relief in those patients who underwent KA procedures compared to those in the mechanically aligned group. Although benefits in pain relief have been demonstrated, it is currently not clear whether native restoration of individual knee angles via kinematic alignment procedures have an impact on the degree of clinical outcome, patient satisfaction and range of motion post-surgery. The aim of this study will be to assess if reproducing native hip-knee-ankle (HKA) angles via Kinematic Alignment techniques improve clinical outcomes, patient satisfaction and range of motion in patients undergoing TKA procedures.
Interventions
Total Knee Arthroplasty (TKA) is a common intervention administered to treat severe degenerative knee joint disease conditions (such as osteoarthritis). Traditionally, prosthetic joint components have been implanted to be aligned with the mechanical axis of the femur and tibia. This is done in an attempt to restore neutral overall limb alignment and ensure long term implant survival. However, the clinical utility of this approach has recently been questioned with the introduction of kinematic alignment techniques. The concept of kinematic alignment (KA) aims to position TKA implants to match the pre-arthritic anatomy of each individual patient. KA advocates suggest this will improve soft tissue balancing, reduce the need for ligament releases, and enhance functional outcome following TKA. All patients being considered for enrollment in this trial will be undergoing TKR as per usual treatment management plans provided by their referring clinician. Surgery will take place in accredited public hospital surgical theatre by qualified orthopedic surgeons. As part of the TKA procedure, the patients will be implanted with a TGA Approved artificial knee joint prosthesis using kinematic alignment surgical techniques. All patients participating in the trial will be observed over a period of 10 years on the performance of their knee replacement, their degree of movement and satisfaction with their surgery. These parameters will be assessed using the following measures: 1) Patient Reported Outcomes Measures. These consists of several questionnaires including the Forgotten Joint Score, Oxford Knee Score, Knee Injury and Osteoarthritis Score, Visual Analog Satisfaction Score. Participants will be asked to complete the abovementioned questionnaires at seven time points as part of standard of care follow-up consults for TKA (pre-operatively, and again at 9-weeks, 6-months, 1year, 2-years, 5 years and 10-years post surgery). It is anticipated that it will take approximately 15 minutes to complete each set of questionnaires at each time point. These questionnaires will be administered by the either the surgeon or surgeon's administrator during face-to-face consults. 2) Radiological Assessments. Standard x-rays will be taken at seven time points as part of standard of care procedures for TKA to ensure implants are positioned well and functioning as required (pre-operatively, 9-weeks, 6-months, 1 year, 2 years, 5years and 10 years post-surgery). Pre-operative radiological evaluation of the following angles will be determined and compared 6-months post-surgery to confirm native knee angle restoration. - Mechanical alignment of the limb as the angle between a line connecting the mechanical axes of the femur and tibia (HKA) - Mechanical medial proximal tibial angle (mMPTA) - Mechanical lateral distal femur angle (mLDFA) All radiological assessments will be done by a Radiologist at the surgeon's preferred radiology practice.
Sponsors
Eligibility
Inclusion criteria
-Patients with a previous diagnosis of end-stage osteoarthritis who have undergone primary total knee arthoplasty using kinematic alignment techniques. - Patients who understand the study conditions and are willing/able to provide written consent for participation in the study. - Patients who received a GMK Sphere Medacta Medially Stablised Knee Implant based on on-label usage. - Aged over 18 years
Exclusion criteria
- Patients who experienced an adverse event post-surgery unrelated to device implant - Patients with a history or are currently being treated for psychiatric illness/mental disorder - Evidence of either acute or chronic infection either pre or post-surgery - Patients who have had significant prior surgery or trauma to the affected knee (e.g. prior High Tibial Osteotomy, periarticular fracture, recurrent patella dislocation) - Patients with a history or are currently being treated for alcohol or drug abuse