A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus The Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants

Knee Osteoarthritis Clinical Trial

Official title:

A Prospective, Single Blinded, Multi-centre Randomised Controlled Trial Comparing the Post Operative Range of Motion of the P.F.C. Sigma RP-F Knee With the P.F.C. Sigma RP Knee in Primary Total Knee Arthroplasty.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00733369
• Other study ID #: CT 06/03
• Status: Terminated
• Phase: Phase 4
• First received: August 12, 2008
• Last updated: August 25, 2014
• Start date: November 2007
• Est. completion date: April 2012

Study information

• Verified date: August 2014
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeSpain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.

Description:

Primary Outcome: change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F

Secondary endpoints: Comparative evaluation of any post-operative variation between subjects receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 106
• Est. completion date: April 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female subjects, aged between 45 and 75 years inclusive.

• Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.

• Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical 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 present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.

• Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet.

• Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.

Exclusion Criteria:

• Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.

• Female subjects who are pregnant or lactating.

• Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

• Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).

• Subjects who are currently involved in any injury litigation claims.

• Subjects with a known history of poor compliance to medical treatment.

• Subjects who have previously had an osteotomy or significant surgery in the affected knee.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• PFC Sigma RP-F
An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
• PFC Sigma RP
An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
United Kingdom	Arrowe Park Hospital	Wirral	Mersyside

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Pre-op to 1 Year Range of Motion.	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.	1 year	No
Secondary	To Compare the Change in KOOS Pain Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	3-6 months	No
Secondary	To Compare the Change in KOOS Pain Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	1 year	No
Secondary	To Compare the Change in KOOS Pain Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	2 years	No
Secondary	To Compare the Change in KOOS Pain Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	5 years	No
Secondary	To Compare the Change in KOOS Symptoms Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	3-6 months	No
Secondary	To Compare the Change in KOOS Symptoms Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	1 year	No
Secondary	To Compare the Change in KOOS Symptoms Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	2 years	No
Secondary	To Compare the Change in KOOS Symptoms Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	5 years	No
Secondary	To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	3-6 months	No
Secondary	To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	1 year	No
Secondary	To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	2 years	No
Secondary	To Compare the Change in KOOS ADL (Activities of Daily Living) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	5 years	No
Secondary	To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	3-6 months	No
Secondary	To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	1 year	No
Secondary	To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	2 years	No
Secondary	To Compare the Change in KOOS SPORTS and RECREATION Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	5 years	No
Secondary	To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	3-6 months	No
Secondary	To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	1 year	No
Secondary	To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 2 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	2 years	No
Secondary	To Compare the Change in KOOS QOL (Quality of Life) Score From Pre-Op to 5 Years Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome that evaluates the short and long-term symptoms and function in subjects with knee injury and osteoarthritis. It consists of 5 separately scored subscales - Pain, Symptoms, Function in daily living (ADL), Function in Sport and Recreation, and knee-related Quality of Life (QOL) - ranging from 0 to 100 point score (where 100 indicates the best outcome).	5 years	No
Secondary	To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 3 to 6 Months Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	3 - 6 months	No
Secondary	To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 1 Year Post Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	1 year	No
Secondary	To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	2 years	No
Secondary	To Compare the Change in American Knee Society (AKS) Knee Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	5 years	No
Secondary	To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.	3 - 6 months	No
Secondary	To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.	1 year	No
Secondary	To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.	2 years	No
Secondary	To Compare the Change in American Knee Society (AKS) Function Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	American Knee Society (AKS) function score is a 0-100 point score (where 100 indicates excellent knee function) that evaluates the affected knee.	5 years	No
Secondary	To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	3 - 6 months	No
Secondary	To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	1 year	No
Secondary	To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	2 years	No
Secondary	To Compare the Change in Oxford Knee Score (OKS) From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	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.	5 years	No
Secondary	To Compare the Change in EQ-5D MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	3 - 6 months	No
Secondary	To Compare the Change in EQ-5D MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	1 year	No
Secondary	To Compare the Change in EQ-5D MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	2 years	No
Secondary	To Compare the Change in EQ-5D MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	5 years	No
Secondary	To Compare the Change in EQ-5D Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	3 - 6 months	No
Secondary	To Compare the Change in EQ-5D Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	1 year	No
Secondary	To Compare the Change in EQ-5D Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	2 years	No
Secondary	To Compare the Change in EQ-5D Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	5 years	No
Secondary	To Compare the Change in EQ-5D Usual Activities Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	3 - 6 months	No
Secondary	To Compare the Change in EQ-5D Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	1 year	No
Secondary	To Compare the Change in EQ-5D Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	2 years	No
Secondary	To Compare the Change in EQ-5D Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	5 years	No
Secondary	To Compare the EQ-5D Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	3 - 6 months	No
Secondary	To Compare the EQ-5D Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	1 year	No
Secondary	To Compare the EQ-5D Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	2 years	No
Secondary	To Compare the Change in EQ-5D Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	5 years	No
Secondary	To Compare the Change in EQ-5D Anxiety/Depression Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	3 - 6 months	No
Secondary	To Compare the Change in EQ-5D Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	1 year	No
Secondary	To Compare the Change in EQ-5D Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	2 years	No
Secondary	To Compare the Change in EQ-5D VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	3 - 6 months	No
Secondary	To Compare the Change in EQ-5D VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	1 year	No
Secondary	To Compare the Change in EQ-5D VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	2 years	No
Secondary	To Compare the Change in EQ-5D VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.	EQ-5D is a patient reported standardized instrument used to measure health that comprises of 5 descriptive dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; and 1 visual analog scale (VAS) that measures health. The descriptive dimensions each have 3 levels: no problems (scored as 1), some problems (scored as 2), and extreme problems (scored as 3); whereas the VAS measure ranges from 0 to 100 where 100 is the best imaginable health state.	5 years	No