Complications, Arthroplasty, Lower Limb Deformity, Osteoarthritis, Post-traumatic Deformity, Rheumatoid Arthritis, Traumatic Arthritis
Conditions
Brief summary
Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.
Detailed description
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.
Interventions
DEVICEVanguard XP Bicruciate Knee System
The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
DEVICEVanguard CR Knee System
The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* cemented application of components * bilateral subjects randomized by knee * patients with pre-existing contralateral knee surgery * painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved * correction of varus, valgus, or posttraumatic deformity * sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament
Exclusion criteria
* cementless application of components * BMI greater than or equal to 40 * use of Anterior Stabilized Bearings * patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees * correction or revision of previous joint replacement procedure on index knee * infection * sepsis * osteomyelitis Relative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Knees Reported as Feels Normal on a Single Assessment Numeric Evaluation (SANE) | 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Knee Society Score | 12 months | 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. |
| Revisions/Removals | 3 years | Number of study device revisions or removals reported during the study. |
| Number of Knees Reported as Feels at Least 80% of Normal on a Single Assessment Numeric Evaluation (SANE) | 12 Months | 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. |
| Number of Knees With Which Participants Reported Being Happy or Very Happy | 12 Months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 22 |
| 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. | 30 |
| 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. | 33 |
| Total | 105 |
Baseline characteristics
| Characteristic | Vanguard XP Bicruciate Knee System | Vanguard CR Knee System | Total |
|---|---|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 8 | 66.4 years STANDARD_DEVIATION 7.3 | 65.5 years STANDARD_DEVIATION 7.6 |
| Modified Knee Society Score | 111.0 score on a scale STANDARD_DEVIATION 27 | 114.5 score on a scale STANDARD_DEVIATION 27.6 | 113.1 score on a scale STANDARD_DEVIATION 27.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 Participants | 30 Participants | 50 Participants |
| Sex: Female, Male Female | 13 Knees | 17 Knees | 30 Knees |
| Sex: Female, Male Male | 9 Knees | 16 Knees | 25 Knees |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 30 |
| other Total, other adverse events | 1 / 1 | 3 / 3 |
| serious Total, serious adverse events | 5 / 20 | 7 / 30 |
Outcome results
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.
Time frame: 12 Months
Population: All knees that contributed a SANE score for function at 12 months were included in the analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vanguard XP Bicruciate Knee System | Number of Knees Reported as Feels Normal on a Single Assessment Numeric Evaluation (SANE) | 1 Knees |
| Vanguard CR Knee System | Number of Knees Reported as Feels Normal on a Single Assessment Numeric Evaluation (SANE) | 2 Knees |
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.
Time frame: 12 months
Population: All patients that contributed a Modified Knee Society Score (mKSS) at 12 months were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vanguard XP Bicruciate Knee System | Modified Knee Society Score | 164.6 score on a scale | Standard Deviation 29.4 |
| Vanguard CR Knee System | Modified Knee Society Score | 168.7 score on a scale | Standard Deviation 30.9 |
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.
Time frame: 12 Months
Population: All knees that contributed a SANE score for function at 12 months were included in the analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vanguard XP Bicruciate Knee System | Number of Knees Reported as Feels at Least 80% of Normal on a Single Assessment Numeric Evaluation (SANE) | 10 Knees |
| Vanguard CR Knee System | Number of Knees Reported as Feels at Least 80% of Normal on a Single Assessment Numeric Evaluation (SANE) | 20 Knees |
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.
Time frame: 12 Months
Population: All patients that contributed a patient satisfaction score at 12 months were included in the analysis.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Vanguard XP Bicruciate Knee System | Number of Knees With Which Participants Reported Being Happy or Very Happy | 12 Knees |
| Vanguard CR Knee System | Number of Knees With Which Participants Reported Being Happy or Very Happy | 18 Knees |
Secondary
Revisions/Removals
Number of study device revisions or removals reported during the study.
Time frame: 3 years
Population: Participants who were randomized, underwent surgery, and received the study device.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vanguard XP Bicruciate Knee System | Revisions/Removals | 0 Revisions/Reoperations |
| Vanguard CR Knee System | Revisions/Removals | 0 Revisions/Reoperations |