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To determine if the use of patient-specific custom cutting blocks for implantation of total knee components results in improved limb alignment and component positioning compared to regular instrumentation.
This is a randomized controlled trial. Patients will be randomized to have their knee implanted using either the patient-specific custom cutting blocks or the regular instrumentation system. Functional and radiographic outcomes will be assessed in a blinded fashion. The Smith and Nephew Legion Primary® total knee system will be used in both groups; this is an implant with a good long term track record based on the Genesis II design. All surgeons have used and are familiar with the regular instrumentation. They will be instructed in the use of the patient-specific custom cutting blocks prior to study initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom Block Instrumentation | Active Comparator | Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system |
|
| Traditional Instrumentation | Active Comparator | Traditional cutting methods for Total Knee Replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visionaire | Device | Custom cutting block using MRI to create patient specific instrumentations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Alignment | Using 3 foot standing film | 8 Weeks |
| Number of HKA Angle Outliers | The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol (EQ) Five Dimension (5D) Survey | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension. |
| Measure | Description | Time Frame |
|---|---|---|
| Other Measure: Time | Surgical and tourniquet time | Intra-operative |
| Blood Loss | Blood loss during surgery >100ml (n) | Intra-operative |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD MPH FRCSC | Orthopaedic Innovation Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31782643 | Derived | Turgeon TR, Cameron B, Burnell CD, Hedden DR, Bohm ER. A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation. Can J Surg. 2019 Dec 1;62(6):460-467. doi: 10.1503/cjs.018318. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Custom Block Instrumentation | Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations |
| FG001 | Traditional Instrumentation | Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Custom Block Instrumentation | Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations |
| BG001 | Traditional Instrumentation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Radiographic Alignment | Using 3 foot standing film | Posted | Mean | Standard Deviation | degree | 8 Weeks |
|
2 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Custom Block Instrumentation | Patients-specific custom cutting blocks using the Smith and Nephew Visionaire system Visionaire: Custom cutting block using MRI to create patient specific instrumentations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision | Infections and infestations | Systematic Assessment | Patient required revision surgery of the knee due to infection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trevor Gascoyne | Orthopaedic Innovation Centre | 204-926-1235 | tgascoyne@orthoinno.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2011 | Apr 29, 2021 | Prot_SAP_000.pdf |
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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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The block randomization process will be stratified by surgeon to ensure equal distribution between the two surgical techniques.
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Randomization will occur after enrolment and subjects will be blinded to assignment group. All subjects will be scheduled for and receive the same MRI experience. It is not possible to blind the surgeon to the surgical technique.
| Traditional | Other | Traditional cutting method |
|
| Preoperative, 1 and 2 years |
| Oxford Knee Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain. | Preoperative, 1 and 2 years |
| Pain Catastrophizing Scale (PCS) Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study. | Preoperative, 1 and 2 years |
| Hip Pain | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported). | Preoperative, 1 and 2 years |
| University of California Los Angeles (UCLA) Activity Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities. | Preoperative, 1 and 2 years |
| Patient Satisfaction | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported). | Preoperative, 1 and 2 years |
| Length of Stay (LOS) | Length of hospital stay | Peri-operative |
| Other Measures: Adverse Events | Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events. Post-operative complication such as infection, loosening, etc. | Peri-operative, intra-operative and post-operative |
Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Knee | Count of Participants | Participants |
|
| Pre-op HKA angle | Mean | Standard Deviation | degree |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | Number of HKA Angle Outliers | The angle formed between the mechanical axes of the femur and tibia create the hip-knee-ankle (HKA) angle. | Posted | Number | outliers | 8 Weeks |
|
|
|
| Secondary | EuroQol (EQ) Five Dimension (5D) Survey | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the EQ-5D (patient reported). The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state, this health state is range from 0 to 1.0. Higher scores indicate improved quality of life within each dimension. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 1 and 2 years |
|
|
|
| Secondary | Oxford Knee Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Oxford 12 scores (patient reported). The score ranges from 0 to 48 with higher scores indicating improved function and less pain. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 1 and 2 years |
|
|
|
| Secondary | Pain Catastrophizing Scale (PCS) Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the PCS (patient reported). The total score ranges from 0 to 52 with higher scores indicating greater pain catastrophizing. Sub-scales will not be used in this study. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 1 and 2 years |
|
|
|
| Secondary | Hip Pain | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Pain Visual Analog Scale (VAS). The scale is from 0 to 100, 0=no pain and at 100= worst pain. (patient reported). | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 1 and 2 years |
|
|
|
| Secondary | University of California Los Angeles (UCLA) Activity Score | Evaluate change from preoperative baseline to 1 and 2 year post operative in activity level assessments using the UCLA Activity score (patient reported). The scale ranges from 1-10 with higher values associated with more intense activities. | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 1 and 2 years |
|
|
|
| Secondary | Patient Satisfaction | Evaluate change from preoperative baseline to 1 and 2 year post operative in functional outcomes assessments using the Satisfaction Visual Analog Scale (VAS). The scale is from 0 to 100, 0=Not Satisfied and at 100=Satisfied. (patient reported). | Posted | Mean | Standard Deviation | units on a scale | Preoperative, 1 and 2 years |
|
|
|
| Other Pre-specified | Other Measure: Time | Surgical and tourniquet time | Posted | Mean | Standard Deviation | Minutes | Intra-operative |
|
|
|
| Other Pre-specified | Blood Loss | Blood loss during surgery >100ml (n) | Posted | Count of Participants | Participants | Intra-operative |
|
|
|
| Other Pre-specified | Length of Stay (LOS) | Length of hospital stay | Posted | Mean | Standard Deviation | Days | Peri-operative |
|
|
|
| Other Pre-specified | Other Measures: Adverse Events | Peri-operative complications such as deep venous thrombosis, pulmonary emboli, wound complications and cardiac events. Post-operative complication such as infection, loosening, etc. | Posted | Number | participants | Peri-operative, intra-operative and post-operative |
|
|
|
| 0 |
| 25 |
| 4 |
| 25 |
| 0 |
| 25 |
| EG001 | Traditional Instrumentation | Traditional cutting methods for Total Knee Replacement Traditional: Traditional cutting method | 0 | 29 | 1 | 29 | 0 | 29 |
|
| Revision | Surgical and medical procedures | Systematic Assessment | Patient required revision surgery due to pain of unknown origin. |
|
| Revision | Surgical and medical procedures | Systematic Assessment | Patient required revision surgery due to an accident |
|
| Manipulation | Surgical and medical procedures | Systematic Assessment | Patient required knee manipulation under anesthesia |
|
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| D012216 |
| Rheumatic Diseases |
| 2 Years |
|
| Improvement at 2 Year |
|
| Improvement at 2 Year |
|
| Improvement at 2 Year |
|
| Improvement at 2 Year |
|
| Improvement at 2 Year |
|