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This is a prospective, multicenter clinical study designed to facilitate the collection and evaluation of workflow efficiency, patient pain and function, and adverse event data. This clinical study will include Persona, NexGen, and Vanguard product families using the ROSA Total Knee Robotic System or conventional instrumentation. The primary objective of this study is to collect and compare clinical and surgical data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.
The primary objective of this study is to collect and compare clinical outcomes data using the commercially available ROSA Total Knee robotic instrumentation and conventional instrumentation.The assessments will include:Planned vs actual component positioning, workflow efficiency, patient safety based on incidence and frequency of adverse events, and clinical performance measured by overall pain and function, quality of life data, and radiographic parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Assisted TKA | Active Comparator | Robotic Assisted TKA |
|
| Conventional TKA | Active Comparator | Conventional TKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERSONA Total Knee | Device | Primary Total Knee Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Performance | EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score. | Pre-op (Baseline), 6 weeks, 3 months, and 1 year |
| Oxford | Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe). | Pre-op (Baseline), 6 weeks, 3 months, and 1 year |
| Post-Operative Pain & Satisfaction | Post-Operative Pain & Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied. | 6 weeks, 3 months, and 1 year |
| Total Range of Motion | Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop | Pre-op (Baseline), 6 weeks, 3 months, and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vail-Summit Orthopaedics | Vail | Colorado | 81657 | United States | ||
| Cornerstone Orthopedics & Sports Medicine, a division of Orthopedic Centers of Colorado, LLC |
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A maximum of 300 subjects are to be competitively enrolled in this study across all sites; a maximum of 10 U.S sites will contribute, with participating sites each enrolling up to 75 implanted knees. Sites will enroll up to 45 patients using The ROSA Knee System and up to 30 patients using Conventional instrumentation using a consecutive and concurrent approach; total study enrollment into these arms is not to exceed 180 subjects and 120 subjects respectively.
| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Assisted TKA | Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty |
| FG001 | Conventional TKA |
| 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 | Oct 2, 2020 |
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| Vanguard Total Knee | Device | Primary Total Knee Arthroplasty |
|
| NexGen Total Knee | Device | Primary Total Knee Arthroplasty |
|
| Westminster |
| Colorado |
| 80023 |
| United States |
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| OrthoVirginia Chippenham | North Chesterfield | Virginia | 23225 | United States |
Conventional TKA
PERSONA Total Knee: Primary Total Knee Arthroplasty
Vanguard Total Knee: Primary Total Knee Arthroplasty
NexGen Total Knee: Primary Total Knee Arthroplasty
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Assisted TKA | Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty |
| BG001 | Conventional TKA | Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty |
| 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, Categorical | Count of Units | Knees | Knees |
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| ||||||||||||||||||||||
| Sex: Female, Male | Count of Units | Knees | Knees |
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| Ethnicity (NIH/OMB) | Count of Units | Knees | Knees |
| |||||||||||||||||||||||
| Kellgren Lawrence | The Kellgren-Lawrence grade was determined by a Principal Investigator review of the preop knee images for a baseline measurement. A Kellgren-Lawrence grading scale score of greater than or equal to, or less than 3 was used to determine the severity of the units; a score of 3 indicates multiple osteophytes, definite joint space narrowing, sclerosis, and possibly bone deformity. (Kellgren-Lawrence score scale: 0 being no joint space narrowing to 4 being severe joint space narrowing) | Count of Units | Knees | 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 | Clinical Performance | EQ-5D Questionnaire: A questionnaire completed by the Patient and assesses his/her General Health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations. The scale is from 0-1, 0 being dead and 1 being the best possible score. | Only subjects with valid EQ5D scores at the follow-up time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-op (Baseline), 6 weeks, 3 months, and 1 year | Knee | Knee |
|
|
| |||||||||||||||||||||||
| Primary | Oxford | Oxford Knee Score: The Oxford Knee Score is a patient completed 12-question metric to rate a patient's knee pain and function using an ordinal 0 - 4 point scale. The total score is obtained by calculating the sum of the 12 items. The minimum score is 0 (most severe) and the maximum score is 48 points (least severe). | Only subjects with valid Oxford scores at the follow-up time points are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre-op (Baseline), 6 weeks, 3 months, and 1 year | Knee | Knee |
|
| ||||||||||||||||||||||||
| Primary | Post-Operative Pain & Satisfaction | Post-Operative Pain & Satisfaction Survey. The scale range for the level of satisfaction ranges is very satisfied, satisfied, uncertain, and unsatisfied. | Only subjects with Patient Satisfaction form at the follow-up time points are included in the analysis. | Posted | Count of Units | Knee | 6 weeks, 3 months, and 1 year | Knee | Knee |
|
| |||||||||||||||||||||||||
| Primary | Total Range of Motion | Total Range of Motion Change from Preop to 1 year. The scale includes the total range of motion (0 degrees of knee extension (fully straightened knee) and 135 degrees of knee flexion) from preop to 1-year postop | Only subjects with valid ROM scores at the follow-up time points are included in the analysis. | Posted | Mean | Standard Deviation | degrees | Pre-op (Baseline), 6 weeks, 3 months, and 1 year | Knee | Knee |
|
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All adverse events reported throughout each subject's length of participation in the study are included. Length of participation is defined as the implantation date through the date of study closure or the date of subject withdrawal for an average of 1 year.
Subjects are counted only once in each category, even if they experienced more than one adverse event in the specific category.
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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 | Robotic Assisted TKA | Robotic Assisted TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty | 0 | 133 | 7 | 133 | 52 | 133 |
| EG001 | Conventional TKA | Conventional TKA PERSONA Total Knee: Primary Total Knee Arthroplasty Vanguard Total Knee: Primary Total Knee Arthroplasty NexGen Total Knee: Primary Total Knee Arthroplasty | 0 | 48 | 1 | 48 | 20 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transverse Femur Fracture at site of ROSA pins | Surgical and medical procedures | Systematic Assessment |
| ||
| Patient seen for 2nd opinion at another orthopaedic provider. Diagnosed with tibial Loosening | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stiffness/Limited Motion due to missing PT; Patient underwent open lysis of adhesions and poly swap. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Patellar Periprosthetic Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anemia and Melena | Blood and lymphatic system disorders | Systematic Assessment |
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| Calf Pain/Possible DVT | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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| Contralateral Knee Replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Inability to eat/full/nausea/vomiting/diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Urinary tract infection/unable to void | Renal and urinary disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Infection (non-knee) | Infections and infestations | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Hip/DJD | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nonunion Femur Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar Stenosis/Degenerative Disc/Facet Disease | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Plantar Fascitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Contralateral Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Right Frontal Ischemic Infarct | Nervous system disorders | Systematic Assessment |
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| Neuro not intact to Left foot and ankle unable to Dorsiflex | Nervous system disorders | Systematic Assessment |
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| Lytic Lesions in Thoracic Spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Amelanotic Melanoma Right Upper Arm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Possible DVT | Vascular disorders | Systematic Assessment |
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| Nasal Bleeding | Vascular disorders | Systematic Assessment |
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| Pulmonary Embolism | Vascular disorders | Systematic Assessment |
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| Mild Crepitus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Stiffness/Limited ROM | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Traumatic Injury/Twisting | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Superficial Infection of Incision | Infections and infestations | Systematic Assessment |
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| Irritation of the distal aspect of Incision | Infections and infestations | Systematic Assessment |
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| Severe Swelling of the surgical knee following surgery | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Trauma/Fall | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Periprosthetic Joint Infection | Infections and infestations | Systematic Assessment |
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| Dermatitis/allergic reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arthritis Increased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizzy/Nausea from medication | Surgical and medical procedures | Systematic Assessment |
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| Wound Dehiscence Left Ankle | Injury, poisoning and procedural complications | Systematic Assessment |
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| Stress Reaction at Femoral Pin Sites | Surgical and medical procedures | Systematic Assessment |
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| Patella Dislocation | Surgical and medical procedures | Systematic Assessment |
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| Skyline Patella Lateral Tilt and Erosion of Non-Resurfaced Patella | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Zimmer Biomet, Inc. | 8006136131 | Clinicaloperations@zimmerbiomet.com |
| Feb 1, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056304 | Genu Valgum |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint 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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| >=65 years |
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| Knees |
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| 6 Week |
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| 3 Month |
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| 1 Year |
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| Knee |
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| Knee |
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| Knee |
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| Uncertain |
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| Unsatisfied |
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