Avascular Necrosis, Juvenile Rheumatoid Arthritis, Osteoarthritis, Other Inflammatory Arthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Total Knee Replacement, Knee Prosthesis
Brief summary
The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
Detailed description
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
Interventions
DEVICETotal Knee Arthroplasty
Rotating Platform (RP) Cruciate Substituting Knee System
DEVICETotal knee replacement
Fixed Cruciate Substituting Knee System
Sponsors
DePuy Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis * Rheumatoid arthritis * Other inflammatory arthritis * Avascular necrosis (AVN) of bone * Post-Traumatic Arthritis * Juvenile Rheumatoid Arthritis
Exclusion criteria
* History of recent/active joint sepsis. * Charcot neuropathy. * Psycho-social disorders that would limit rehabilitation. * Greater than 75 years of age at the time of surgery. * Prior ipsilateral knee arthroplasty. * Metabolic disorders of calcified tissues, such as Paget's disease. * Severe diabetes mellitus. * Joint replacement due to autoimmune disorders. * Skeletal immaturity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. | The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor. |
Secondary
| Measure | Time frame |
|---|---|
| Complications | On-going to end of study |
| Revisions | On-going to end of study |
| Medical Imaging | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| SF-12 Patient Outcomes | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
Countries
United States
Participant flow
Recruitment details
Between April 2001 and October 2002, 106 subjects were recruited and enrolled at 3 US clinics by orthopaedic surgeons. Each study site could enroll up to 50 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.
Pre-assignment details
Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the clinical investigation plan.
Participants by arm
| Arm | Count |
|---|---|
| Rotating Platform P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. | 77 |
| Fixed Bearing P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base. | 72 |
| Total | 149 |
Baseline characteristics
| Characteristic | Rotating Platform | Fixed Bearing | Total |
|---|---|---|---|
| Age, Continuous | 64.5 years STANDARD_DEVIATION 6.3 | 65.5 years STANDARD_DEVIATION 7.2 | 65.0 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment United States United States | 77 Participants | 72 Participants | 149 Participants |
| Sex: Female, Male Female | 48 Participants | 55 Participants | 103 Participants |
| Sex: Female, Male Male | 29 Participants | 17 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 77 | 8 / 72 |
| serious Total, serious adverse events | 15 / 77 | 6 / 72 |
Outcome results
Primary
Knee Society Score
The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and \< 60 = poor.
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotating Platform | Knee Society Score | 12 Months | 96.1 Scores on a scale | Standard Deviation 6.6 |
| Rotating Platform | Knee Society Score | 36 Months | 97.2 Scores on a scale | Standard Deviation 5.2 |
| Rotating Platform | Knee Society Score | 6 Months | 90.8 Scores on a scale | Standard Deviation 13.8 |
| Rotating Platform | Knee Society Score | 48 Months | 95.8 Scores on a scale | Standard Deviation 5.9 |
| Rotating Platform | Knee Society Score | 24 Months | 96.8 Scores on a scale | Standard Deviation 7.6 |
| Rotating Platform | Knee Society Score | 60 Months | 93.6 Scores on a scale | Standard Deviation 9 |
| Rotating Platform | Knee Society Score | Pre-operative | 39.3 Scores on a scale | Standard Deviation 15.8 |
| Fixed Bearing | Knee Society Score | 60 Months | 93.5 Scores on a scale | Standard Deviation 8.9 |
| Fixed Bearing | Knee Society Score | Pre-operative | 37.2 Scores on a scale | Standard Deviation 16.5 |
| Fixed Bearing | Knee Society Score | 6 Months | 89.2 Scores on a scale | Standard Deviation 13.9 |
| Fixed Bearing | Knee Society Score | 12 Months | 93.0 Scores on a scale | Standard Deviation 9.9 |
| Fixed Bearing | Knee Society Score | 24 Months | 96.0 Scores on a scale | Standard Deviation 7.9 |
| Fixed Bearing | Knee Society Score | 36 Months | 94.3 Scores on a scale | Standard Deviation 9.9 |
| Fixed Bearing | Knee Society Score | 48 Months | 93.7 Scores on a scale | Standard Deviation 9.2 |
Secondary
Complications
Time frame: On-going to end of study
Secondary
Medical Imaging
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.
Secondary
Revisions
Time frame: On-going to end of study
Secondary
SF-12 Patient Outcomes
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.