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The purpose and primary objective of this study is to compare health economic outcomes between the use of a patient-matched cutting guide (Visionaire) versus the use of standard instrumentation in Total Knee Arthroplasty(TKA). Data will be collected pre-operatively, intra-operatively and post operatively up until and including the six week post-operative assessment. The secondary objectives of the study are to compare safety and early readmission rates between the two techniques. The study hypothesis is that there is no difference in the cost of the episode of care from hospital admission to discharge, including pre-operative radiology costs and cost of resources, with the Visonaire patient-matched cutting guide compared to standard instrumentation.
This is a prospective, randomised pilot study comparing the health economic outcomes between TKA using standard instrumentation and TKA using a patient-matched cutting guide. The primary indication for this study is degenerative arthritis of the knee requiring unilateral primary total knee arthroplasty. Patients requiring TKA who are eligible and have consented to participate will be randomised to TKA with The Genesis IIâ„¢ Total Knee Implant System or the Legionâ„¢ Primary Total Knee System using either Visionaireâ„¢ patient-matched cutting guides or standard instrumentation. The study will recruit for 1 year and patients will have a final follow up at the six week post-operative assessment.
The primary objective of this study will evaluate the cost of the episode of care from hospital admission to discharge. This will include pre-operative costs, anesthetic costs, operative and theatre costs, costs of instruments and resources. The study will also measure length of stay as well as blood transfusion requirements. The secondary objectives of this study are to compare the safety and early readmission rates between the two techniques, by measuring the complication rates intra-operatively and post-operatively as well as the number of patients readmitted to hospital prior to the six week post-operative assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA with standard instrumentation | No Intervention | This arm consists of the Genesis II Total knee implant system or the Legion Primary total knee system with standard instrumentation | |
| Total knee arthroplasty with Visionaire | Active Comparator | This arm will consist of the Genesis II Total Knee Implant System or Legion Primary Total Knee System with the Visionaire patient-matched instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total knee arthroplasty with Visionaire | Device | Patient Specific Instrumentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost of the episode of care from admission to hospital to discharge | The cost of the episode of care from admission to hospital to discharge , including pre-operative radiology costs and costs associated with Visionaire and will incorporate the costs of time, number of instruments utilised, blood transfusion requirements, length of stay and pre-operative xray and MRI costs. | up to 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients that experience short term complications and/or early readmissions | Percentage of patients experiencing intra-operative complications, post operative complications, post discharge complications or readmissions prior to the 6 week post-operative assessment. | up to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Baker | Private Practice | Principal Investigator |
| Lieth Stewart | Life Claremont Hospital | Principal Investigator |
| Willem Tollig | Pretoria East Hospital | Principal Investigator |
| Michael Barrow | Sunninghill Hospital | Principal Investigator |
| Dan Potgieter | Life Bay View Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Life Bay View Hospital | Mossel Bay | Cape Town | 6506 | South Africa | ||
| Sunninghill Hospital |
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| Johannesburg |
| Gauteng |
| South Africa |
| Pretoria East Hospital | Pretoria | Gauteng | South Africa |
| Private Practice | Durban | KwaZulu-Natal | 4001 | South Africa |
| Life Claremont Hospital | Cape Town | Western Cape | South Africa |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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