PFC Sigma Fixed and Mobile Knee Study

Phase 4

Terminated

Conditions: Osteoarthritis, Knee

Interventions: Device: P.F.C Sigma Fixed Bearing total knee system
Device: P.F.C Sigma RP Mobile Bearing knee system

Registration Number: NCT00208325

Lead Sponsor: DePuy International

Brief Summary: The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice.

Detailed Description: The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 754

Inclusion Criteria

Male or female subjects may be recruited to the evaluation.
Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing.

Exclusion Criteria

Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Patients who require revision total knee arthroplasty surgery.
Patients with any tibial deformity requiring tibial component augmentation.
Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.
Patients with Rheumatoid Arthritis.
Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.
Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.
Contra-indications for use of the device, as detailed in the package insert.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
Subjects who are currently involved in another clinical study with an investigational product.
Subjects who are currently involved in any injury litigation claims.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PFC Sigma Fixed Bearing PCL Retained	P.F.C Sigma Fixed Bearing total knee system	PFC Sigma Fixed Bearing Total Knee System with PCL Retained
PFC Sigma RP PCL Sacrificed	P.F.C Sigma RP Mobile Bearing knee system	PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
PFC Sigma RP PCL Retained	P.F.C Sigma RP Mobile Bearing knee system	PFC Sigma Rotating Platform Total Knee System with PCL Retained
PFC Sigma Fixed Bearing PCL Sacrificed	P.F.C Sigma Fixed Bearing total knee system	PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed

Primary Outcome Measures

Name	Time	Method
To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	1 year	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.
To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	1 year	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.
To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 1 year	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.
To Compare the Change in Range of Motion From Pre-op to 1 Year Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 1 year	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.

Secondary Outcome Measures

Name	Time	Method
To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 2 years	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.
To Compare the Change in Range of Motion From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 2 years	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.
To Compare the Change in Range of Motion From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 years	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.
To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 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.
To Compare the Change in Oxford Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 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.
To Compare the Change in Oxford Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 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.
To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 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.
To Compare the Change in American Knee Society Knee Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 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.
To Compare the Change in American Knee Society Knee Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 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.
To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 2 years	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.
To Compare the Change in American Knee Society Function Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 2 years	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.
To Compare the Change in American Knee Society Function Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 years	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.
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	5 Years	Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	2 years	Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	5 Years	Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	2 years	Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 2 years	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. 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).
To Compare the Change in SF-12 Physical Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 2 years	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. 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).
To Compare the Change in SF-12 Physical Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 years	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. 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).
To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 2 years	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. 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).
To Compare the Change in SF-12 Mental Health Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 2 years	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. 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).
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	5 Years	Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.
To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	2 years	Tibial Radiolucency observes a radiolucent line (of 0.5mm or wider) on the radiograph around the tibial component.
To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Operative	Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.
To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Operative	Lateral release is a surgical procedure to release tight capsular structures (lateral retinaculum) on the outside of the kneecap (patella). It is performed during knee surgery and allows the kneecap to move smoothly in the center of the knee. Rate information was collected at time of study surgery.
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	5 Years	Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	2 Years	Kaplan Meier survivorship analysis estimates the proportion of a population that will survive past a certain time avoiding a certain event. In this study, the event is removal of any component for any reason, also known as revision for any reason. Survival estimates are provided when 40 devices are left still being followed.
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	5 Years	Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	5 Years	Anterior Knee Pain is assessed by the patient into 1 of 4 categories: None, Mild, Moderate, or Severe. The percentage of participants with no anterior knee pain is reported in the data table.
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	5 Years	Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	5 Years	Quadriceps Strength is assessed by the patient into 1 of 3 categories: Good, Fair, or Poor. The percentage of participants with good quadriceps strength is reported in the data table.
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	Change from pre-op to 2 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	Change from pre-op to 2 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
To Compare the Change in SF-12 Mental Health Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 years	The 12-Item Short Form Health Survey (SF-12) is a patient reported outcome survey that represents overall subjective health status by measuring eight health-related parameters (each scored from 0 \[poor health\] to 100 \[better health\]): body pain, general mental health, perception of general health, physical functioning, role limitations caused by mental condition, role limitations caused by a physical condition, social functioning, and vitality. 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).
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 2 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
To Compare the Change in Patella Score From Pre-op to 2 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm	Change from pre-op to 2 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm	Change from pre-op to 5 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups With Patella Resurfacing in the PCL Sacrificing Arm	Change from pre-op to 5 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.
To Compare the Change in Patella Score From Pre-op to 5 Years Between Sigma RP and Sigma Fixed Bearing Treatment Groups Without Patella Resurfacing in the PCL Sacrificing Arm	Change from pre-op to 5 years	The Patella Score is completed by the clinicians and assesses the anterior knee pain, quadriceps strength, ability to rise from a chair and stair climbing. The Patella Score ranges from 3 to 30 points with higher scores indicating better functionality and lower scores indicating poorer functionality.

Trial Locations

Locations (4): Glasgow Royal Infirmary
🇬🇧
Glasgow, United Kingdom
Glasgow Western Infirmary
🇬🇧
Glasgow, United Kingdom
Northampton General Hospital
🇬🇧
Northampton, United Kingdom
Nottingham City Hospital
🇬🇧
Nottingham, United Kingdom