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Data no longer required to meet regulatory requirements.
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Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanguard XP Bicruciate Knee System | Experimental | 153 patients receive Vanguard XP Bicruciate Knee System |
|
| Vanguard CR Knee System | Active Comparator | 153 patients receive Vanguard CR Knee System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vanguard XP Bicruciate Knee System | Device | The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE) | Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Knee Society Score | The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
Relative exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Orthopaedics at Rush University Medical Center | Chicago | Illinois | 60605 | United States | ||
| University of Utah Orthopaedic Center |
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After obtaining informed consent, participants were evaluated according to protocol-defined eligibility (inclusion and exclusion) criteria. If a participant did not meet the eligibility criteria, he or she was excluded from participation and not assigned to a study group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vanguard XP Bicruciate Knee System | Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue. |
| FG001 | Vanguard CR Knee System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jan 15, 2014 |
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| Vanguard CR Knee System | Device | The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design. |
|
| 12 months |
| Revisions/Removals | Number of study device revisions or removals reported during the study. | 3 years |
| Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE) | Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function. | 12 Months |
| Number of Knees With Which Participants Reported Being "Happy" or "Very Happy" | Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy." | 12 Months |
| Salt Lake City |
| Utah |
| 84108 |
| United States |
Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
| 12 Month Follow-Up Visit | Participants for which the primary endpoint of Modified Knee Society Score (mKSS) at 12 months could be analyzed. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vanguard XP Bicruciate Knee System | Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue. |
| BG001 | Vanguard CR Knee System | Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Knees |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Knees |
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| Sex: Female, Male | Count of Units | Knees | Knees |
| |||||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | Participants |
| |||||||||||||||||||||
| Modified Knee Society Score | The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes. | Mean | Standard Deviation | score on a scale | Knees |
|
| 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 | Number of Knees Reported as "Feels Normal" on a Single Assessment Numeric Evaluation (SANE) | Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function. | All knees that contributed a SANE score for function at 12 months were included in the analysis. | Posted | Count of Units | Knees | 12 Months | Knees | Knees |
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| Secondary | Modified Knee Society Score | The American Knee Society Score is part clinical exam and part patient administered assessment of the knee. The objective part of the score was collected in the clinic by qualified personnel. The functional and pain components of the score were collected by patient completed questionnaire. Total scores can range from 0 to 200, with higher scores indicating better outcomes. | All patients that contributed a Modified Knee Society Score (mKSS) at 12 months were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 12 months | Knees | Knees |
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| Secondary | Revisions/Removals | Number of study device revisions or removals reported during the study. | Participants who were randomized, underwent surgery, and received the study device. | Posted | Number | Revisions/Reoperations | 3 years |
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| Secondary | Number of Knees Reported as "Feels at Least 80% of Normal" on a Single Assessment Numeric Evaluation (SANE) | Participants answered a Single Assessment Numeric Evaluation (SANE) which asked how they rated their knee function. A score of 100 indicates normal and anything below 100 indicates a percentage of normal function. | All knees that contributed a SANE score for function at 12 months were included in the analysis. | Posted | Count of Units | Knees | 12 Months | Knees | Knees |
|
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| Secondary | Number of Knees With Which Participants Reported Being "Happy" or "Very Happy" | Participants answered a survey which asked how they they would describe their satisfaction with their new joint. Options for answers included "I have never been happy," "Ok - but not perfect," "Happy," and "Very Happy." | All patients that contributed a patient satisfaction score at 12 months were included in the analysis. | Posted | Count of Units | Knees | 12 Months | Knees | Knees |
|
|
3 years
Per the study protocol, only device-related and serious adverse events were collected in this study.
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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 | Vanguard XP Bicruciate Knee System | Vanguard XP Bicruciate Knee System: The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue. | 0 | 20 | 5 | 20 | 1 | 1 |
| EG001 | Vanguard CR Knee System | Vanguard CR Knee System: The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design. | 0 | 30 | 7 | 30 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture of patella | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Effusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Instability Medial/Lateral | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Stiff knee resulting in manipulation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Effusion/swelling and pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Synvectomy and lysis of adhesions | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Sciatic nerve pain | Nervous system disorders | Non-systematic Assessment |
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| Pain, stiffness, decrease in satisfaction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiograph radiolucency seen under tibial platform | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nerve Deficit | Nervous system disorders | Non-systematic Assessment |
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| Periosteal reaction medial cortex | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Effusion and pain to knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Early termination leading to small numbers of subjects analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hillary Overholser | Zimmer Biomet | 574-933-4180 | hillary.overholser@zimmerbiomet.com |
| Feb 16, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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