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Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during Total Knee Replacement (TKR) is of great importance as it contributes to better function, less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. Malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening.
Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. Customized instrumentation created from a preoperative CT has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. However, taking into consideration CT's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be used routinely as a postoperative tool to evaluate TKR implant positioning.
The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for CT and ten times less than the plain radiography) by using a gaseous detector. George Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS system can provide 3D images by using the appropriate software algorithms, thus providing a low-radiation alternative to CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual (tibia) and manual (femur) | Other | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component |
|
| Manual (tibia) and custom (femur) | Other | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component |
|
| Custom (tibia) and custom (femur) | Other | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component |
|
| Custom (tibia) and manual (femur) | Other | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medacta GMK Sphere | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Hip-Knee-Angle (HKA) | Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation | Pre-operative, 6 wks. post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Tibial Varus Deformity | Measured change between pre-operative planning report & post-operative EOS longstanding radiograph in varus deformity of the operative joint | Pre-operative, 6 wks. post-op |
| Femoral Valgus Deformity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine Department of Orthopaedic Surgery | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Manual (Tibia) and Manual (Femur) | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component Medacta GMK Sphere |
| FG001 | Manual (Tibia) and Custom (Femur) | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component Medacta GMK Sphere |
| FG002 | Custom (Tibia) and Custom (Femur) | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component Medacta GMK Sphere |
| FG003 | Custom (Tibia) and Manual (Femur) | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component Medacta GMK Sphere |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Manual (Tibia) and Manual (Femur) | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component Medacta GMK Sphere |
| BG001 | Manual (Tibia) and Custom (Femur) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Post-Operative Hip-Knee-Angle (HKA) | Measured HKA change from pre-operative EOS longstanding X-ray to post-operative EOS at 6wks. comparing groups receiving manual instrumentation versus custom instrumentation | Sub group analysis of only participants who received both manual or both custom instrumentations. | Posted | Mean | Standard Deviation | Degrees | Pre-operative, 6 wks. post-op |
|
Intraoperative period - 6 wks. post-operative
Participation in this study does not expose participants to risks beyond or different from the risks associated with the total knee replacement surgery designated as standard of care.
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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 | Manual (Tibia) and Manual (Femur) | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for both the tibia component and the femur component Medacta GMK Sphere |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Shauver, MPH | Northwestern University | 312-472-6024 | melissa.shauver1@nm.org |
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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 | Oct 15, 2018 | Mar 18, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2018 | Mar 18, 2019 | ICF_001.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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Measured change between pre-operative planning report & post-operative EOS longstanding radiograph in varus deformity of the operative joint
| Pre-operative, 6 wks. post-op |
| Tibial Posterior Slope (Mean Deviation) | Deviation from pre-operative planning template & 6 wk. post-operative longstanding EOS radiograph | Pre-Operative - 6 wk. Post-Operative |
Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component
Medacta GMK Sphere
| BG002 | Custom (Tibia) and Custom (Femur) | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component Medacta GMK Sphere |
| BG003 | Custom (Tibia) and Manual (Femur) | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component Medacta GMK Sphere |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
Participants who received custom instrumentation guides for both the tibial and femoral component of the total knee implant; study group Custom-Custom
|
|
| Secondary | Tibial Varus Deformity | Measured change between pre-operative planning report & post-operative EOS longstanding radiograph in varus deformity of the operative joint | Analysis combining groups receiving manual vs custom tibial instrumentation. | Posted | Mean | Standard Deviation | Degrees | Pre-operative, 6 wks. post-op |
|
|
|
| Secondary | Femoral Valgus Deformity | Measured change between pre-operative planning report & post-operative EOS longstanding radiograph in varus deformity of the operative joint | Combined analysis of participants who received manual vs custom femoral instrumentation. | Posted | Mean | Standard Deviation | Degrees | Pre-operative, 6 wks. post-op |
|
|
|
| Secondary | Tibial Posterior Slope (Mean Deviation) | Deviation from pre-operative planning template & 6 wk. post-operative longstanding EOS radiograph | Combined analysis of participants who received manual vs custom tibial instrumentation | Posted | Mean | Standard Deviation | Degrees | Pre-Operative - 6 wk. Post-Operative |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Manual (Tibia) and Custom (Femur) | Knee replacement with Medacta GMK Sphere implants using manual instrumentation for the tibia component and custom instrumentation for the femur component Medacta GMK Sphere | 0 | 16 | 0 | 16 | 0 | 16 |
| EG002 | Custom (Tibia) and Custom (Femur) | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for both the tibia component and the femur component Medacta GMK Sphere | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Custom (Tibia) and Manual (Femur) | Knee replacement with Medacta GMK Sphere implants using custom instrumentation for the tibia component and manual instrumentation for the femur component Medacta GMK Sphere | 0 | 16 | 0 | 16 | 0 | 16 |
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| D012216 |
| Rheumatic Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|