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The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.
The study design is a prospective, multicenter, study of the commercially available Persona fixed bearing knee implants. The study will require each site to obtain Institutional Review Board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.
All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty. The post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, 2, 3, 4, and 5 years.
All info specified in the Brief Summary will be captured via the Knee Society Score, EQ-5D, Forgotten Joint Score, KSS Patient Expectations, Physical Exam, and Physician's Assessment of Radiographic Outcomes form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona TKA | Other | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer Persona Total Knee System | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Scores | This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain. | 5 years post op |
| Measure | Description | Time Frame |
|---|---|---|
| EQ-5D | The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death. |
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Inclusion Criteria:
Patient 18-75 years of age, inclusive;
Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
Patient has participated in a study-related Informed Consent process;
Patient is willing and able to complete scheduled study procedures and follow-up evaluations;
Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kacy Arnold, RN MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Midwest Orthopaedics at Rush | Naperville | Illinois | 60563 | United States | ||
| The Rothman Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Persona TKA | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System Zimmer Persona Total Knee System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. Therefore, 299 are included in this submission.
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| ID | Title | Description |
|---|---|---|
| BG000 | Persona TKA | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System Zimmer Persona Total Knee System |
| 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 | Knee Society Scores | This form includes alignment, instability, joint range of motion, and symptoms. The overall range of scores available is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain. | Only 161 subjects completed the KSS form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up. | Posted | Mean | Full Range | units on a scale | 5 years post op |
|
Postoperatively through study completion (5yr follow-up).
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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 | Persona TKA | Primary total knee arthroplasty subjects that receive the Zimmer Persona Total Knee System Zimmer Persona Total Knee System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment | Chest pain Chest pressure Congestive Heart Failure Atrial Fibrillation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Specialist | Zimmer Biomet | 5745497606 | tim.swanson@zimmerbiomet.com |
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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 3, 2014 | Mar 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 5 years post op |
| Forgotten Joint Score (FJS) | The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement). | 5 years post-op |
| Egg Harbor |
| New Jersey |
| 08234 |
| United States |
| Duke University | Durham | North Carolina | 27701 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Adverse Event |
|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| EQ5D-5L | Each EQ-5D comprises a short descriptive questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death. | Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs). | Mean | Full Range | units on a scale |
|
| Knee Society Score - Objective Knee | This form includes alignment, instability, joint range of motion, and symptoms. The overall scoring range is -8 to 106. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the very likely experience of symptoms of pain. | Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs). | Mean | Full Range | units on a scale |
|
| KSS Patient Expectations | This is a 3 question form to evaluate a patient's expectations of their knee replacement prior to receiving it. This score serves as the baseline to measure how expectations were met postoperatively. The overall score possibility ranges from 3 to 15. A score of 3 would indicate that the patient has very low expectations for surgery, and a score of 15 would indicate that the patient has very high expectations for surgery in terms of relief of pain, performing normal activities, and performing recreational activities. | Patient demographics were captured for 326 subjects, however 27 subjects were study completed prior to surgery and prior to pre-op Patient Report Outcome Measure Completion. All other analyses will include 299 subjects (beginning with PROMs). | Mean | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | EQ-5D | The EQ-5D family of instruments has been developed to evaluate health across a wide range of disease areas. Each EQ-5D instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a simple descriptive profile of a respondent's health state. The EQ VAS provides an alternative way to elicit an individual's rating of the individual's own overall current health. The overall range is -0.1 to 1.0. A higher score indicates a better overall health rating reported by the patient, and a lower score indicates a poor overall health rating. It is possible to score a negative value. Although unlikely, a negative value is observed to be a state worse than death. | Only 175 subjects completed the EQ-5D form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up. | Posted | Mean | Full Range | units on a scale | 5 years post op |
|
|
|
| Secondary | Forgotten Joint Score (FJS) | The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total knee arthroplasty (TKA). Scores range from 0-100. A score of 100 would indicate a high degree of "forgetting" the artificial joint (a low degree of awareness). A score of 0 would indicates a very low degree of "forgetting" the artificial joint (typically aware of the replacement). | Only 176 subjects completed the FJS form at the final 5yr follow-up. All other subjects were study completed, or lost to follow-up. | Posted | Mean | Full Range | units on a scale | 5 years post-op |
|
|
|
| 4 |
| 299 |
| 72 |
| 299 |
| 227 |
| 299 |
|
| Generic Cardiovascular Reports | Cardiac disorders | Non-systematic Assessment | Cerebral Ischemic Stroke Blockage in Artery DX of SVT |
|
| Dermatological Disorders | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Hives and rashes Cellulitis left shin |
|
| Adrenal insufficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | Appendicitis Gall Bladder Bleeding ulcers Colon resection |
|
| Genitourinary / Renal | Renal and urinary disorders | Non-systematic Assessment |
|
| Hematological | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Infection (non-knee) | Infections and infestations | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neurological | Nervous system disorders | Non-systematic Assessment |
|
| Oncological | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Pulmonary / Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Wound Drainage / Device Loosening | Surgical and medical procedures | Non-systematic Assessment |
|
| Other General Adverse Events | General disorders | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Other General Adverse Events | General disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |