None listed
Conditions
Brief summary
Malalignment in total knee replacement is a major cause of failure. Traditionally, alignment is facilitated through the use of mechanical jigs to position cutting blocks. There is however debate as to the accuracy of such jig systems. This study will employ a relatively new alternative method in which patient matched instrumentation as opposed to conventional jig-assisted techniques are used. This study will look at the accuracy of TKR’s performed using instrumentation which is specific to the patient. A CT scan will be performed on the patients’ knee after the operation to assess how accurate this patient specific instrumentation is.
Interventions
Patient matched total knee replacement involves a preoperative CT scan which is then processed by the manufacturer to produce a preliminary preoperative report outlining proposed resection levels. This is then reviewed by the surgical team and, if approved, is then sent back to the manufacturer where the custom made cutting block is manufactured.
During surgery, the cutting block is attached directly to the patients bony anatomy during and promotes accurate resection of the both the femoral an
Patient matched total knee replacement involves a preoperative CT scan which is then processed by the manufacturer to produce a preliminary preoperative report outlining proposed resection levels. This is then reviewed by the surgical team and, if approved, is then sent back to the manufacturer where the custom made cutting block is manufactured. During surgery, the cutting block is attached directly to the patients bony anatomy during and promotes accurate resection of the both the femoral and tibial bones. The procedure takes approximately 60 minutes. The system used in this study will include but is not limited to Medacta Orthopaedic patient matched knee system-MyKnee Registered Trademark. Proposed benefits of this system include improved accuracy, reduced cost and decreased operating times.
Sponsors
Dr. Arash Nabavi
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The individual has read and understood the patient information statement (PIS) and signed a consent form specific to this study. 2. The individual is over 18 years of age. 3. The individual has been given a primary diagnosis of osteoarthritis. 4. The individual clinically qualifies for total knee arthroplasty surgery based on physical examination and medical history. 5. The individual is physically and mentally willing and able to comply with scheduled clinical and radiographic evaluations (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse). 6. The individual does not have a systemic disease that would affect their welfare or the overall outcome of the study, is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 7. The individual is skeletally mature.
Exclusion criteria
1. The individual is unable or unwilling to read the patient information statement (PIS) and sign the consent form specific to this study. 2. The individual has had a previous fracture of the femoral condyles, tibia plateau, or femora/tibial shaft. 3. The individual has had a previous osteotomy around the knee. 4. The individual is physically or mentally compromised (i.e., is currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, alcohol or substance abuse), and is unable to comply with scheduled clinical and radiographic evaluations. 5. The individual has a neuromuscular or neurosensory deficiency which limits their ability to evaluate the safety and effectiveness of the device. 6. The individual has an active infection within the affected joint. 7. The individual has had a previous total knee replacement. 8. The individual is pregnant.
Outcome results
None listed