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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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Analyze clinical data for a group of subjects implanted with a new surgical device designed to reduce the incidence of patellar crepitus following PCL-substituting TKA and compare that to a control group of subjects implanted with a TKA design known to have an incidence of patellar crepitus of approximately 5%.
Patellar crepitus and clunk following posterior cruciate substituting total knee arthroplasty is a persistent problem with a reported incidence as high as 14%. The development of this complication necessitates additional surgery in some patients. Numerous etiologies have been reported including design of the femoral component. Due to a higher than desired incidence of patellar crepitus with the PFC Sigma PS TKA, design modifications of the trochlear groove of the femoral component were introduced with the release of the PFC Sigma HP PS femoral component. The purpose of the proposed study is to evaluate the incidence of patellar crepitus after posterior cruciate substituting TKA utilizing the PFC Sigma vs. the PFC Sigma HP PS femoral components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFC Sigma PS TKA | one group received primary TKA using the PFC Sigma PS TKA | ||
| PFC Sigma HP PS TKA | One group received primary TKA using the PFC Sigma HP PS TKA. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication. | Two years after TKA (Total Knee Arthroplasty) procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Colorado Joint replacement clinic
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Kim, MD | Porter Adventist Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | PFC Sigma PS TKA (Total Knee Arthroplasty) | One group received primary TKA using the PFC Sigma PS TKA |
| FG001 | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | One group received primary TKA using the PFC Sigma HP PS TKA. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PFC Sigma PS TKA (Total Knee Arthroplasty) | One group received primary TKA using the PFC Sigma PS TKA |
| BG001 | PFC Sigma HP PS TKA (Total Knee Arthoplasty) | One group received primary TKA using the PFC Sigma HP PS TKA. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluate for the Incidence of Patellar Crepitus Requiring Non-operative vs. Operative Treatment of Both the Study and Control Groups at a Minimum of 12 Months Following the TKA (Total Knee Arthroplasty) Procedure in Each Subject. | The incidence of patellar crepitus and clunk will be statistically compared between the study (PFC Sigma HP PS TKA) and control (PFC Sigma PS TKA groups). Based on a strength analysis to determine a theoretical reduction in the incidence of patellar crepitus from 5% to 2%, a study group of 625 subjects in both the control and study ggroups will be required. Each group will also be statistically analyzed using the following variables: overall crepitus incidence, incidence of crepitus requiring only non-operative treatment vs. those requiring operative treatment to manage this complication. | Posted | Number | participants | Two years after TKA (Total Knee Arthroplasty) procedure |
|
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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 | PFC Sigma PS TKA (Total Knee Arthroplasty) | One group received primary TKA using the PFC Sigma PS TKA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Failed total knee due to infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Raymond Kim, MD | Colorado Joint Replacement | 720-524-1367 | raymondkim@ccentura.org |
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| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
One group received primary TKA using the PFC Sigma PS TKA
| OG001 | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | One group received primary TKA using the PFC Sigma HP PS TKA. |
|
|
| 45 |
| 625 |
| 0 |
| 625 |
| EG001 | PFC Sigma HP PS TKA (Total Knee Arthroplasty) | One group received primary TKA using the PFC Sigma HP PS TKA. | 29 | 625 | 0 | 625 |
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Colon cancer with liver metastases |
|
| Failed total knee due to arthrofibrosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Failed TKA due to chronic patellofemoral and mild tibiofemoral instability | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Death | General disorders | Systematic Assessment | Unknown cause |
|
| Death | Cardiac disorders | Systematic Assessment | Cause of Death: MI |
|
| Periprosthetic fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Cerebellar tumor, esophageal cancer |
|
| Dehiscence | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chronic lateral patellar irritation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Bladder cancer |
|
| Death | Infections and infestations | Systematic Assessment | Cause of death: sepsis |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Lung cancer |
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| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Lung cancer |
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| Hemarthrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Below knee amputation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Total hip replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Femoral fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | Nondisplaced femoral neck fracture |
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| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Cause of death: Pneumonia |
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| Death | Cardiac disorders | Systematic Assessment |
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| Failed TKA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Failed TKA due to quadriceps tendon rupture |
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| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Conralateral TKA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Lumbar stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hetrotrophic bone formation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
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| Peroneal nerve entrapment | Nervous system disorders | Systematic Assessment |
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| Achilles tendon rupture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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