Clinical trial NCT00208325: PFC Sigma Fixed and Mobile Knee Study
Official title: Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Lead sponsor: DePuy International
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 1 year
measure: To Compare Range of Motion Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
timeFrame: 1 year
measure: 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
timeFrame: Change from pre-op to 1 year
measure: 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
timeFrame: Change from pre-op to 1 year
Secondary outcomes:
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 2 years
measure: To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
timeFrame: 2 years
measure: To Compare the Percentage of Subjects With No Anterior Knee Pain Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 5 Years
measure: To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 2 years
measure: To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
timeFrame: 2 years
measure: To Compare the Percentage of Subjects With Good Quadriceps Strength Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 5 Years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 2 years
measure: To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
timeFrame: 2 years
measure: To Compare the Percentage of Subjects With at Least 1 Tibial Radiolucency Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 5 Years
measure: To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: Operative
measure: To Compare the Percentage of Subjects With Lateral Release Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
timeFrame: Operative
measure: To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 2 Years
measure: To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Retaining Arm
timeFrame: 2 Years
measure: To Compare the Survivorship Analysis Results Between Sigma RP and Sigma Fixed Treatment Groups in PCL Sacrificing Arm
timeFrame: 5 Years
measure: 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
timeFrame: 2 Years
measure: 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
timeFrame: 2 Years
measure: 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
timeFrame: 5 Years
measure: 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
timeFrame: 5 Years
measure: 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
timeFrame: 2 Years
measure: 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
timeFrame: 2 Years
measure: 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
timeFrame: 5 Years
measure: 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
timeFrame: 5 Years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 2 years
measure: 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
timeFrame: Change from pre-op to 5 years
measure: 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
timeFrame: Change from pre-op to 5 years
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Glasgow Western Infirmary
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital
Study officials:
References: