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The primary objective of this study is to evaluate clinical performance for the commercially available Persona TM Tibia used in primary cementless tibia total knee arthroplasty.
This is a prospective, multicenter, non-randomized clinical study designed to facilitate the collection and evaluation of radiographic parameters, pain and function, survival of the device,and adverse event data.
The study will require each site to obtain 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 cementless tibia total knee arthroplasty. An immediate postoperative radiograph will be required. Postoperative clinical follow-up and radiographic evaluations will be conducted at 6 weeks, 6 months, 1 year, and 2 years.
The primary endpoint of this study is to evaluate the clinical performance of the implant at 2 years postoperatively using radiographic parameters. Radiographs will be assessed for the absence of progressive tibial radiolucencies, as defined in the radiographic protocol.
The secondary endpoints of this study will evaluate the clinical performance of the implant at 2 years postoperatively, based upon:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona TM Tibia subjects | Other | Subjects that receive the Persona TM Tibia implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persona TM Tibia | Device | Trabecular Metal tibia used in primary cementless total knee arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiograph Assessment of Progressive Tibial Radiolucencies | Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of >0.5 mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 maximum score is 48 points (best) and the minimum score is 0 points (worst). | 2 years |
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Inclusion Criteria:
Patient is at least 18 years of age.
Patient qualifies for a primary cementless tibia 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 the study-related Informed Consent process.
Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved Informed Consent Form.
Patient is willing and able to complete scheduled study procedures and follow-up evaluations as described in the Informed Consent Form.
Independent of study participation, patient is a candidate for commercially available cementless Persona TM tibial knee component, implanted in accordance with product labeling.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA BioMed at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States | ||
| Cornerstone Orthopaedics & Sports Medicine, P.C. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Persona TM Tibia | Persona Trabecular Metal (TM) Tibia used in primary cementless total knee arthroplasty |
| 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 | Feb 5, 2018 |
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| Revision Rate |
Rate of the number of revisions for any reason |
| 2 years |
| Wheat Ridge |
| Colorado |
| 80033 |
| United States |
| Hawaii Pacific Health | Honolulu | Hawaii | 96813 | United States |
| Henry County Orthopedics and Sports Medicine | New Castle | Indiana | 47362 | United States |
| Woods Mill Orthopedics, Ltd | Chesterfield | Missouri | 63017 | United States |
| Pinehurst Surgical Clinic | Pinehurst | North Carolina | 28374 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| COMPLETED | 102 participants (120 knees) completed the 2 year follow-up physical exam. |
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| NOT COMPLETED |
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Demographics are being reported for the 148 knees that received the Persona TM Tibia implant (study device).
| ID | Title | Description |
|---|---|---|
| BG000 | Persona TM Tibia | Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Units | Knees | Knees |
| ||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Units | Knees | Knees |
| ||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Radiograph Assessment of Progressive Tibial Radiolucencies | Progressive tibial radiolucency will be derived in accordance with the following definitions: Absent: No evidence of an increase in either radiolucency extent (number of zones involved) or measured width within a zone. Present: Presence of either: An increase in the number of zones with a measured tibial radiolucency, OR an increase in the measured tibial radiolucency width within a zone of >0.5 mm. Unable to assess: One or more of the component factors necessary to derive progressive tibial radiolucency is unavailable. | 99 participants (117 knees) had radiographs analyzed at the 2 year follow-up interval. | Posted | Count of Units | Knees | 2 years | Knees | Knees |
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| Secondary | 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 maximum score is 48 points (best) and the minimum score is 0 points (worst). | 97 participants (115 knees) completed the Oxford Knee Score (OKS) at the 2 year follow-up interval. Literature suggests that Oxford Knee Scores above 41 are considered excellent and scores from 34 to 41 are considered good. The endpoint was designed to distinguish scores above 38. Reference: Murray et al. (2007). The use of the Oxford hip and knee scores. Bone & Joint Journal, 89(8), 1010-1014 | Posted | Count of Units | Knees | 2 years | Knees | Knees |
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| Secondary | Revision Rate | Rate of the number of revisions for any reason | A revision is when the study implant is removed/revised due to an adverse event. Of the 148 knees that received the Persona TM Tibia implant, there were 2 reported revisions. | Posted | Count of Units | Knees | 2 years | Knees | Knees |
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Adverse events were collected for each participant from the date of study device surgery through the 2 year follow-up interval. An exception is for the participants who did not complete the study, where adverse events were collected through the date of when the participant exited the 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 | Persona TM Tibia | Persona Trabecular Metal Tibia used in primary cementless total knee arthroplasty | 4 | 125 | 15 | 125 | 69 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis/Redness/Blistering | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Study knee related |
| |
| Contralateral Knee Replacement (UKA or TKA) | Surgical and medical procedures | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Deep Wound Infection | Infections and infestations | Non-systematic Assessment | Study knee related |
| |
| Effusion/Swelling/Edema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
| |
| Endocrine | Endocrine disorders | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Hematological/Abnormal Lab | Blood and lymphatic system disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Infection (not study knee) | Infections and infestations | Non-systematic Assessment | General adverse event (not study knee) |
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| Musculoskeletal (not study knee) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Pain (progressive/persistent) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
| |
| Traumatic Injury (not study knee) | Injury, poisoning and procedural complications | Non-systematic Assessment | General adverse event (not study knee) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Cellulitis/Redness/Blistering | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Study knee related |
| |
| Clicking/Popping/Crepitus/Grinding | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
| |
| Contralateral Knee Replacement (UKA or TKA) | Surgical and medical procedures | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Deep Wound Infection | Infections and infestations | Non-systematic Assessment | Study knee related |
| |
| Dermatological | Skin and subcutaneous tissue disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Effusion/Swelling/Edema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
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| Endocrine | Endocrine disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Femoral Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Genitourinary/Renal | Renal and urinary disorders | Non-systematic Assessment |
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| Hematological/Abnormal Lab | Blood and lymphatic system disorders | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Infection (not study knee) | Infections and infestations | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Musculoskeletal (not study knee) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Neurological | Nervous system disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Other General Adverse Event | General disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Other Ipsilateral Knee Related Adverse Event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
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| Pain (progressive/persistent) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
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| Patellar Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
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| Psychological | Psychiatric disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Pulmonary/Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | General adverse event (not study knee) |
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| Stiffness/Limited ROM (progress/persistent) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Study knee related |
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| Traumatic Injury (not study knee) | Injury, poisoning and procedural complications | Non-systematic Assessment | General adverse event (not study knee) |
| |
| Traumatic Injury (study knee) | Injury, poisoning and procedural complications | Non-systematic Assessment | Study knee related |
| |
| Wound Dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Study knee related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Zimmer Biomet | 800-613-6131 | clinicaloperations@zimmerbiomet.com |
| Jun 14, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| 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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| Asian |
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| Hispanic or Latino |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Title | Measurements |
|---|---|
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| Knees |
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