Avascular Necrosis of Bone, Juvenile Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to evaluate the clinical performance of the rotating platform and fixed bearing implants in patients undergoing primary total knee replacement. Outcome scoring and radiographic assessment will be the methods used to evaluate performance.
Detailed description
This study will evaluate the clinical performance of rotating platform and fixed bearing knee implants. This will be done by obtaining a series of primary total knee replacements. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Retaining Knee System or the P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System and assignment is randomized.
Interventions
DEVICETotal Knee Replacement
Rotating Platform (RP) Cruciate Retaining Knee System
DEVICETotal knee replacement
Fixed Cruciate Retaining 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 of bone
Exclusion criteria
* Prior ipsilateral TKA * Metabolic disorders * Joint replacement due to autoimmune disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Scores | 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/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
Two US clinical centers performed 99 primary knee replacements in 86 subjects. Recruitment was based on the inclusion and exclusion criteria as specified 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 CIP.
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. | 50 |
| 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. | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | Rotating Platform | Fixed Bearing | Total |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 6.2 | 66.9 years STANDARD_DEVIATION 5.1 | 65.3 years STANDARD_DEVIATION 5.9 |
| Region of Enrollment United States | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 31 Participants | 26 Participants | 57 Participants |
| Sex: Female, Male Male | 19 Participants | 23 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 3 / 50 | 1 / 49 |
Outcome results
Primary
Knee Society Scores
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 Scores | 6 months | 84.3 Scores on a scale | Standard Deviation 14.7 |
| Rotating Platform | Knee Society Scores | 12 months | 86.4 Scores on a scale | Standard Deviation 13 |
| Rotating Platform | Knee Society Scores | 48 months | 94.3 Scores on a scale | Standard Deviation 5.6 |
| Rotating Platform | Knee Society Scores | 24 months | 89.7 Scores on a scale | Standard Deviation 9.2 |
| Rotating Platform | Knee Society Scores | Pre-operative | 40.8 Scores on a scale | Standard Deviation 19.8 |
| Rotating Platform | Knee Society Scores | 36 months | 92.3 Scores on a scale | Standard Deviation 8.2 |
| Rotating Platform | Knee Society Scores | 60 months | 95.0 Scores on a scale | Standard Deviation 4.6 |
| Fixed Bearing | Knee Society Scores | 36 months | 87.1 Scores on a scale | Standard Deviation 10.4 |
| Fixed Bearing | Knee Society Scores | Pre-operative | 43.4 Scores on a scale | Standard Deviation 23 |
| Fixed Bearing | Knee Society Scores | 48 months | 86.0 Scores on a scale | Standard Deviation 14.7 |
| Fixed Bearing | Knee Society Scores | 60 months | 95.5 Scores on a scale | Standard Deviation 3.5 |
| Fixed Bearing | Knee Society Scores | 12 months | 86.4 Scores on a scale | Standard Deviation 10 |
| Fixed Bearing | Knee Society Scores | 24 months | 88.1 Scores on a scale | Standard Deviation 8.8 |
| Fixed Bearing | Knee Society Scores | 6 months | 77.8 Scores on a scale | Standard Deviation 14.9 |
Secondary
Complications/Revisions
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
SF-12 Patient Outcomes
Time frame: Pre-operative, 6 and 12 months and annually thereafter for at least 5 years.