Total Knee Replacement
Conditions
Keywords
total knee replacement, patellar crepitus, Replacement of knee joint
Brief summary
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%.
Detailed description
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.
Interventions
None listed
Sponsors
DePuy Orthopaedics
Colorado Joint Replacement
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* subjects that received primary total knee replacement
Exclusion criteria
* Did not return for follow - up appointments Required any post operative manipulation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Two years after TKA (Total Knee Arthroplasty) procedure | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PFC Sigma PS TKA (Total Knee Arthroplasty) One group received primary TKA using the PFC Sigma PS TKA | 625 |
| PFC Sigma HP PS TKA (Total Knee Arthoplasty) One group received primary TKA using the PFC Sigma HP PS TKA. | 625 |
| Total | 1,250 |
Baseline characteristics
| Characteristic | PFC Sigma PS TKA (Total Knee Arthroplasty) | PFC Sigma HP PS TKA (Total Knee Arthoplasty) | Total |
|---|---|---|---|
| Age, Continuous | 65.6 Years | 65.6 Years | 65.6 Years |
| Region of Enrollment United States | 625 participants | 625 participants | 1250 participants |
| Sex: Female, Male Female | 350 Participants | 352 Participants | 702 Participants |
| Sex: Female, Male Male | 275 Participants | 273 Participants | 548 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 625 | 0 / 625 |
| serious Total, serious adverse events | 45 / 625 | 29 / 625 |
Outcome results
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.
Time frame: Two years after TKA (Total Knee Arthroplasty) procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PFC Sigma PS TKA (Total Knee Arthroplasty) | 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. | Positive Crepitus | 78 participants |
| PFC Sigma PS TKA (Total Knee Arthroplasty) | 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. | Symptomatic Crepitus | 31 participants |
| PFC Sigma PS TKA (Total Knee Arthroplasty) | 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. | Operative Crepitus | 18 participants |
| PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 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. | Positive Crepitus | 82 participants |
| PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 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. | Symptomatic Crepitus | 24 participants |
| PFC Sigma HP PS TKA (Total Knee Arthroplasty) | 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. | Operative Crepitus | 7 participants |