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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-006 | Other Identifier | Stryker |
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| Name | Class |
|---|---|
| Stryker Instruments | INDUSTRY |
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The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.
The purpose of this study is to determine the survivorship rate of robotically guided MultiCompartmental Knee system (MCK) medial onlay Unicompartmental Knee Arthroplasty (UKA) implants at a two, five, and ten year follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAKOplasty® medial UKA | Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAKOplasty® medial UKA | Procedure | A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee. |
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| Measure | Description | Time Frame |
|---|---|---|
| 10 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 10 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 5 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | 5 years after surgery |
| 2 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent a MAKOplasty procedure by the investigating surgeon and received a medial MCK onlay implant.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Borus, MD | Rebound Orthopedics and Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rebound Orthopedics and Neurosurgery | Vancouver | Washington | 98686 | United States |
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Participants were recruited from 179 subjects who received a robotically guided medial unicompartmental knee arthroplasty (UKA) by the investigating surgeon and were at least 2 years post-operation as of December 30, 2011. Of the 179 subjects contacted by post card and/or a phone call 145 agreed to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robot Assisted Medial Partial Knee Replacement | Patients knees that have received a robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robot Assisted Medial Partial Knee Replacement | Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 10 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | Posted | Count of Participants | Participants | 10 years after surgery |
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2, 5 and 10 years post surgery.
The only adverse event collected was death of subject from all causes at 2, 5 and 10 years post surgery.
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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 | MAKOplasty® Medial UKA | Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant. MAKOplasty® medial UKA: A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Fairchild | Rebound Research and Education Foundation. | 3604498728 | pfairchild@reboundmd.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2013 | Apr 11, 2022 | Prot_000.pdf |
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|
| 2 years after surgery |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 5 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | Posted | Count of Participants | Participants | 5 years after surgery |
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|
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| Secondary | 2 Year Survivorship of Components | Survivorship of components is defined as knee implant device(s) remaining in patient. | Posted | Count of Participants | Participants | 2 years after surgery |
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|
| 8 |
| 145 |
| 0 |
| 145 |
| 0 |
| 145 |
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