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PFC Sigma Fixed and Mobile Knee Study

This study has been terminated.
(The study was terminated at the point the primary endpoint and early milestones were reached and because long term outcomes were available from other sources)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208325
First received: September 13, 2005
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Osteoarthritis, Knee
Device: P.F.C Sigma Fixed Bearing total knee system
Device: P.F.C Sigma RP Mobile Bearing knee system
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 1 year ] [ Designated as safety issue: No ]
    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:
  • 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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Sacrificing Arm [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Sacrificing Arm [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 5 Years Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Sacrificing Arm [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Operative ] [ Designated as safety issue: No ]
    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 [ Time Frame: Operative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    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 Sacrificing Arm [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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 With Patella Resurfacing in the PCL Sacrificing Arm [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
    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 With Patella Resurfacing in the PCL Sacrificing Arm [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from pre-op to 5 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 754
Study Start Date: May 2000
Study Completion Date: September 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PFC Sigma Fixed Bearing PCL Sacrificed
PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
Device: P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
Active Comparator: PFC Sigma RP PCL Sacrificed
PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
Device: P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement
PFC Sigma Fixed Bearing PCL Retained
PFC Sigma Fixed Bearing Total Knee System with PCL Retained
Device: P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
Active Comparator: PFC Sigma RP PCL Retained
PFC Sigma Rotating Platform Total Knee System with PCL Retained
Device: P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects may be recruited to the evaluation.
  2. 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.
  3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  4. 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.
  5. Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
  6. 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:

  1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
  2. Patients who require revision total knee arthroplasty surgery.
  3. Patients with any tibial deformity requiring tibial component augmentation.
  4. Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.
  5. Patients with Rheumatoid Arthritis.
  6. Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.
  7. Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.
  8. Contra-indications for use of the device, as detailed in the package insert.
  9. Women who are pregnant.
  10. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
  11. Subjects who are currently involved in another clinical study with an investigational product.
  12. Subjects who are currently involved in any injury litigation claims.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208325

Locations
United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Glasgow Western Infirmary
Glasgow, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1LB
Sponsors and Collaborators
DePuy International
  More Information

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208325     History of Changes
Other Study ID Numbers: CT 9923 
Study First Received: September 13, 2005
Results First Received: June 5, 2015
Last Updated: August 1, 2016
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 27, 2016