This post-market clinical follow-up study was designed to compile long-term knee replacement outcomes of the PFC Sigma fixed and PFC Sigma mobile Rotating Platform (RP) knee systems. The first patient had surgery on November 8, 2001 and the final patient had surgery on July 29, 2005. There were 120 knees consented by a single site, which was the planned sample size in the study protocol, with 117 receiving one of the study devices. The study was terminated as the primary outcome was met and the investigator decided to conduct the study without sponsor support after 2009.
Performance and safety will be assessed using the following surgeon and patient based outcome tools: 1. American Knee Society Knee and Function Scores 2. Knee Society Radiological Analysis 3. Oxford Knee Score 4. SF 12 Score 5. Anterior Knee Pain Score Specific objectives of the evaluation being to assess the following: 1. Improvement in functional recovery 2. Incidence of anterior knee pain 3. Improvement in Quality of life 4. Incidence of tibial loosening 5. Incidence of excessive polyethylene wear
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
PFC Sigma Fixed Bearing system for use in total knee arthroplasty
PFC Sigma Mobile Bearing system for use in total knee arthroplasty
Middlesborough General Hospital
Middlesbrough, United Kingdom
To Compare Range of Motion (ROM) between subjects receiving Sigma Rotating Platform mobile bearing and Sigma fixed bearing components
Range of motion is knee flexion (how far the patient can bend their knee) minus knee extension (how far the patient can straighten their knee). The result of this subtraction is the range of motion (bending and straightening) for that knee.
Time frame: 1 year
Change in SF-12 Physical and Mental Component Scores from Baseline to 1 and 2 years
The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into 2 summary measures that are scored from 0 to 100 (where 100 indicates the highest level of health) - the Physical Component Score (PCS-12) and Mental Component Score (MCS-12). At times, the survey is also displayed via 8 domain scales that are also scored from 0 to 100 (where 100 indicates the highest level of health) as follows: Physical Function, Role Physical, Bodily Pain, General Health, Mental Health, Role Emotional, Social Function, and Vitality. The response metric is the change score, or delta, from pre-operative assessment to post-operative assessment.
Time frame: 1 and 2 years
Change in American Knee Society Knee and Function Scores from Baseline to 1 and 2 years
American Knee Society (AKS) knee score is a 0-100 point score (where 100 indicates excellent knee condition) that evaluates the affected knee. The knee score is composed of Pain, Range of Motion, and Stability. American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee. The function score is composed of Walking and Stair Climbing ability.
Time frame: 1 and 2 years
Change in Oxford Knee Score from Baseline to 1 and 2 years
The Oxford Knee Score (OKS) is a 12 to 60 point patient reported outcome (PRO) score (where 12 indicates the best outcome) that evaluates the affected knee. The total score is composed of Pain and Function.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 and 2 years
Change in Anterior Knee Pain from Baseline to 1 and 2 years
Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe.
Time frame: 1 and 2 years
Incidence of Femoral Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and \> 2mm, the number of knees is displayed.
Time frame: 6 weeks to 3 Months through 1 year
Incidence of Tibial Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and \> 2mm, the number of knees is displayed.
Time frame: 6 weeks to 3 Months through 1 year
Incidence of Patellar Radiolucencies at one year
Radiolucent lines (RLL) are looked for radiographically by component, from an AP view, and, if present and \> 2mm, the number of knees is displayed.
Time frame: 6 weeks to 3 Months through 1 year