None listed
Conditions
Brief summary
Total knee joint replacement is a successful operation for the relief of symptoms such as pain, loss of function and inability to perform daily activities. New techniques are constantly being developed to improve these results even further. This study aims to see how well a very new technique for total knee joint replacement surgery performs in a small number of patients. The technique involves patients having a MRI scan before their operation. This scan enables very detailed 3-D pictures of the bones, cartilage and soft-tissues around the hip, knee and ankle to be obtained. This information is then used to reconstruct a 3-D model of the pre-disease anatomy for that particular patient. This model is used to create two plastic blocks which will be used by the surgeon to perform a total knee joint replacement. Specific questions about how precise the cutting guides can be positioned onto the bone (that is, if the guides are positioned several times, how much does the position vary?) and are there advantages in the recovery and function of patients in the period after their operation will be addressed by this study. The results of this study will be compared to the results obtained using similar total joint replacement components. Patients will be asked to complete surveys to assess their pain, quality of life and knee function before and after their operation. It is hoped that the information collected during this multi-centre study will provide valuable information regarding the use of patient-specific cutting guides for total knee joint replacement.
Interventions
Patient-specific cutting guides will be manufactured based on pre-operative Magnetic Resonance Imaging (MRI) scans. Total knee arthroplasty will be peformed using computer-assisted surgery. The approximate duration of the procedure is 90-120 minutes. Participants will undergo either intra-operative assessment of cutting guide precision (Group A) or use of the cutting guides to perform bony resection of the distal femur and proximal tibia (Group B). Total knee replacement components will be impla
Patient-specific cutting guides will be manufactured based on pre-operative Magnetic Resonance Imaging (MRI) scans. Total knee arthroplasty will be peformed using computer-assisted surgery. The approximate duration of the procedure is 90-120 minutes. Participants will undergo either intra-operative assessment of cutting guide precision (Group A) or use of the cutting guides to perform bony resection of the distal femur and proximal tibia (Group B). Total knee replacement components will be implanted. Participants whre the cutting guides were used in surgery will undergo post-operative Computed Tomography (CT) scans.
Sponsors
Stryker Australia
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is a male or non-pregnant female between the ages of 50-90. 2. The patient requires a primary total knee replacement and is indicated for computer-assisted surgery. 3. The patient has a primary diagnosis of osteoarthritis (OA). 4. The patient has intact collateral ligaments. 5. The patient is able to undergo MRI scanning of the affected limb. 6. The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Informed Consent document. 7. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion criteria
1. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint. 2. Patient has had a high tibial osteotomy or femoral osteotomy. 3. The patient is morbidly obese (Body Mass Index, BMI = 40). 4. The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System. 5. The patient has a varus/valgus malalignment = 15 degrees. 6. The patient has a fixed flexion deformity = 15 degrees. 7. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 8. The patient has a systemic or metabolic disorder leading to progressive bone deterioration. 9. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 10. Patient has a cognitive impairment, an intellectual disability or a mental illness. 11. The patient is pregnant. 12. The patient has no metal hardware present in the region of the hip, knee or ankle 13. The patient has any known contraindications for undergoing assessment by MRI
Outcome results
None listed