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| Name | Class |
|---|---|
| LSS Surgical Pty Ltd | UNKNOWN |
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This project aims to assess two different techniques used to position the knee replacement implant during surgery. The patients will be randomised to receive either the following:
The study hypothesis is there will be no difference between the gold standard Navigation system and the Prophecy technique in relation to the placement of the knee implant.
Knee joint pain is often the cause of reduced joint and limb function. Total knee joint replacement is a procedure which aims to relieve pain and help to improve mobility. There has been continued development and improvement in knee implant design and the instruments required during surgery to assist with the accurate placement of the implant. These developments have reduced surgery time and assisted in the accurate positioning of the knee implant, which leads to better long term outcomes.
Navigation system is a computerised system currently used intraoperatively to position the Advance knee implant. The Prophecy technique is a pre-operative alignment technique. Patient undergo a MRI or CT scan which is used to manufacture personalised cutting blocks which are then used intraoperatively to position the knee implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation alone | Active Comparator | Navigation system alone vs Prophecy technique with Navigation system validation |
|
| Prophecy and Navigation validation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophecy Technique | Device | Navigation computerised system is used intraoperatively to correct implant the Advance knee implant. Prophecy is a pre-alignment technique where a pre-op MRI or CT scan is used to manufacture personalised cutting blocks to assist the surgeon in correct implanting the Advance knee implant intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Prophecy Guide Outcomes in Total Knee Replacement Surgery | The primary objective of this study is to investigate the Prophecy technique and compare its outcomes to the established navigation (Gold standard) technique | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prophecy Guide Outcomes in Total Knee Replacement Surgery | The secondary objectives are to evaluate the:
| 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugh English | Contact | +61 1300 436 454 | hugh@boss.net.au | |
| Kath Hore | Contact | +61 1300 436 454 | kath@boss.net.au |
| Name | Affiliation | Role |
|---|---|---|
| Hugh English | Brisbane Orthopaedic Specialist Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Spirit Northside Private Hospital | Chermside | Queensland | 4032 | Australia |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000085022 | Surgical Navigation Systems |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
|
| Navigation System | Device |
|
| Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
|
| D012216 |
| Rheumatic Diseases |