Knee OsteoarthritisPhase 4NCT00733369

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

A Phase 4 study testing PFC Sigma RP-F and PFC Sigma RP in people with Knee Osteoarthritis, run by DePuy International at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 45 to 75 years
Conditions the study is for: Knee Osteoarthritis
What is being tested?: PFC Sigma RP-F and PFC Sigma RP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 2 sitesin 2 countries
Study dates: Nov 2007to Aug 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Spain1 site

Hospital Clinic i Provincial de Barcelona
Barcelona

Other trials in Spain

United Kingdom1 site

Arrowe Park Hospital
Metropolitan Borough of Wirral, Mersyside

Other trials in United Kingdom

About this study

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.

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.

Read the detailed 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)

Conditions: Knee Osteoarthritis
Being tested: PFC Sigma RP-F, PFC Sigma RP
Keywords: Arthroplasty, Replacement, Knee, PFC Sigma RPF, PFC Sigma RP
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PFC Sigma RP-FDevice
An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RPDevice
An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

Study groups in NCT00733369
Study group	Role	What they receive
PFC Sigma RP-F	Other	125 patients to be allocated to this arm according to blinding envelopes Receives: Device: PFC Sigma RP-F
PFC Sigma RP	Active comparator	125 patients to be allocated to this arm according to blinding envelopes Receives: Device: PFC Sigma RP

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year

Secondary outcomes (55)

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).
Measured: 3-6 months
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).
Measured: 1 year
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).
Measured: 2 years
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).
Measured: 5 years
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).
Measured: 3-6 months
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).
Measured: 1 year
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).
Measured: 2 years
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).
Measured: 5 years
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).
Measured: 3-6 months
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).
Measured: 1 year
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).
Measured: 2 years
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).
Measured: 5 years
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).
Measured: 3-6 months
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).
Measured: 1 year
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).
Measured: 2 years
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).
Measured: 5 years
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).
Measured: 3-6 months
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).
Measured: 1 year
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).
Measured: 2 years
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).
Measured: 5 years
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.
Measured: 3 - 6 months
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.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 5 years
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.
Measured: 3 - 6 months
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.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 5 years
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.
Measured: 3 - 6 months
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.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 5 years
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 3 - 6 months
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 1 year
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 2 years
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 5 years
To Compare the Change in EQ-5D3L 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-5D3L 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.
Measured: 3 - 6 months
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 1 year
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 2 years
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 5 years
To Compare the Change in EQ-5D3L 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-5D3L 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.
Measured: 3 - 6 months
To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 1 year
To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 2 years
To Compare the Change in EQ-5D3L Usual Activities Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 5 years
To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 3 - 6 months
To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 1 year
To Compare the EQ-5D3L Pain/Discomfort Score Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 2 years
To Compare the Change in EQ-5D3L Pain/Discomfort Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 5 years
To Compare the Change in EQ-5D3L 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-5D3L 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.
Measured: 3 - 6 months
To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 1 year
To Compare the Change in EQ-5D3L Anxiety/Depression Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 2 years
To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 3 - 6 months
To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 1 year
To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 2 years
To Compare the Change in EQ-5D3L VAS Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
EQ-5D3L 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.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Aug 2014

First posted13 Aug 2008 (estimated)
Study startNov 2007
Primary completionAug 2010
Study completionAug 2014

Why it stopped: This study was closed for the reason of slow recruitment with only 16% of the target subjects recruited over a 29 month period.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00733369
Sponsor's protocol ID: CT 06/03
Status last verified: Aug 2016
First submitted: 12 Aug 2008
Last updated: 13 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00733369
Acronym / sponsor ID: CT 06/03
Conditions: Knee Osteoarthritis
Keywords: Arthroplasty, Replacement, Knee, PFC Sigma RPF, PFC Sigma RP
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was closed for the reason of slow recruitment with only 16% of the target subjects recruited over a 29 month period.
Enrolment: 106 participants (actual)
Lead sponsor: DePuy InternationalIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Aug 2010 (actual)
Study completion: Aug 2014 (actual)
First posted: 13 Aug 2008 (estimated)
Results: Posted 26 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed 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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PFC Sigma RP-F	Other	Device: PFC Sigma RP-F125 patients to be allocated to this arm according to blinding envelopes
PFC Sigma RP	Active comparator	Device: PFC Sigma RP125 patients to be allocated to this arm according to blinding envelopes

Who may qualify

Ages: 45 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PFC Sigma RP-FAn orthopaedic implant for total knee replacement with a high flexion rotating platform bearing	Device	PFC Sigma RP-F
PFC Sigma RPAn orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing	Device	PFC Sigma RP

Primary outcome

Change From Pre-op to 1 Year Range of Motion.
Time frame: 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.

55 secondary outcomes

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.
Time frame: 3-6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3-6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3-6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3-6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3-6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3 - 6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3 - 6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
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.
Time frame: 3 - 6 months
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.
Time frame: 1 year
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.
Time frame: 2 years
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.
Time frame: 5 years
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 3 - 6 months
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 1 year
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 2 years
To Compare the Change in EQ-5D3L MOBILITY Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 5 years
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 3 to 6 Months Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 3 - 6 months
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 1 Year Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 1 year
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 2 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 2 years
To Compare the Change in EQ-5D3L Self-Care Score From Pre-Op to 5 Years Post-Op Between PFC Sigma RP and PFC Sigma RP-F Treatment Groups.
Time frame: 5 years

Results and safety

Results posted to the registry on 26 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PFC Sigma RP-F	50	40
PFC Sigma RP	56	47

Primary outcome: Change From Pre-op to 1 Year Range of Motion.

Time frame: 1 year. Mean (Standard Deviation). Unit: Degrees

Measure	PFC Sigma RP-F n = 44	PFC Sigma RP n = 51
Value	13.11 (14.89)	10.71 (14.38)

Population analysed: 106 enrolled knees, 11 of which excluded from the analysis due to:{0 Deaths + 8 Protocol Violations(bilaterals accrued at site where bilateral not allowed, used first knee operated upon: 4 investigational \&4 control) + 2 lost to follow up (1 Inv \& 1 Contr) + 1 missing outcome (1 Inv \& 0 Contr)}

55 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event data were collected between treatment time point and 24 month follow up as this study has been terminated early.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PFC Sigma RP-F	7 of 50 (14%)	0 of 50 (0%)	Not reported
PFC Sigma RP	7 of 56 (12.5%)	0 of 56 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Knee Osteoarthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PFC Sigma RP-F and PFC Sigma RP in people with Knee Osteoarthritis, run by DePuy International at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Pre-op to 1 Year Range of Motion. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00733369.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.