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This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient specific instrumentation | Experimental | The patient will undergo using patient specific instrumentation |
|
| Standard instrumentation | Active Comparator | The patient will undergo surgery using standard instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer Patient specific instruments | Device | A custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant alignment | Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score | Patient questionnaire | 1yr, 5yr, 10yr |
| Measure | Description | Time Frame |
|---|---|---|
| EUROQOL-5D | 1 year, 5 years and 10 years | |
| IKKS Score | Questionnaire | 1yr, 5 yr, 10yr |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Blakey, MBChB | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rotherham District General Hospitals NHS Trust | Rotherham | South Yorkshire | S60 2UD | United Kingdom | ||
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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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| Standard instrumentation | Device | Standard instrumentation will be used during total knee replacement surgery. |
|
| Sheffield Teaching Hospital NHS Trust |
| Sheffield |
| South Yorkshire |
| S5 7AU |
| United Kingdom |
| D012216 |
| Rheumatic Diseases |