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

This study has been terminated.
(This study was closed for the reason of slow recruitment with only 16% of the target subjects recruited over a 29 month period.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00733369
First received: August 12, 2008
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Device: PFC Sigma RP-F
Device: PFC Sigma RP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Change from pre-op to 1 year Range of motion. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    ROM is measured as part of the American Knee society score. This assesment details the clinical condition and functionality of the joint.


Secondary Outcome Measures:
  • The variation between the 2 groups on KOOS pain score from baseline to 3-6 months. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS pain score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS pain score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS pain score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on the American Knee Society Clinical Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the American Knee Society Clinical Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the American Knee Society Clinical Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the American Knee Society Clinical Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the Oxford Knee Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their normal daily activities.

  • The variation between the 2 groups on the Oxford Knee Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their normal daily activities.

  • The variation between the 2 groups on the Oxford Knee Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their normal daily activities.

  • The variation between the 2 groups on the Oxford Knee Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The OKS evaluates the patient's perception of the condition and functionality of the affected joint and the impact it has on their normal daily activities.

  • The variation between the 2 groups on the EQ-5D Mobility Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Mobility Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Mobility Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Mobility Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on KOOS symptoms score from baseline to 3-6 months. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS symptoms score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS symptoms score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS symptoms score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS ADL (Activities of Daily Living) score from baseline to 3-6 months. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS ADL (Activities of Daily Living) score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS ADL (Activities of Daily Living) score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS ADL (Activities of Daily Living) score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS Sports and Recreation score from baseline to 3-6 months. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS Sports and Recreation score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS Sports and Recreation score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS Sports and Recreation score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS QOL (Quality of Life) score from baseline to 3-6 months. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS QOL (Quality of Life) score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS QOL (Quality of Life) score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on KOOS QOL (Quality of Life) score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The KOOS asseses the subjects opinion about their knees and associated problems.

  • The variation between the 2 groups on the EQ-5D Self-Care Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Self-Care Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Self-Care Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Self-Care Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Usual Activities Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Usual Activities Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Usual Activities Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Usual Activities Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Pain/Discomfort Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Pain/Discomfort Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Pain/Discomfort Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Pain/Discomfort Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Anxiety/Depression Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Anxiety/Depression Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D Anxiety/Depression Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D VAS Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D VAS Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D VAS Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the EQ-5D VAS Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The EQ-5D evaluates the patient's perception of their health related quality of life.

  • The variation between the 2 groups on the American Knee Society Function Score from baseline to 3-6 months. [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the American Knee Society Function Score from baseline to 1 year. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the American Knee Society Function Score from baseline to 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.

  • The variation between the 2 groups on the American Knee Society Function Score from baseline to 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    AKS is a clinical evaluation of the subjects affected knee and it details the clinical condition and functionality of the joint.


Enrollment: 106
Study Start Date: November 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PFC Sigma RP-F
125 patients to be allocated to this arm according to blinding envelopes
Device: PFC Sigma RP-F
An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
Active Comparator: PFC Sigma RP
125 patients to be allocated to this arm according to blinding envelopes
Device: PFC Sigma RP
An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

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) and Oxford Knee Score (OKS)

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733369

Locations
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
United Kingdom
Arrowe Park Hospital
Wirral, Mersyside, United Kingdom
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Francisco Macule, FRCS Hospital Clinic i Provincial de Barcelona
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00733369     History of Changes
Other Study ID Numbers: CT 06/03
Study First Received: August 12, 2008
Last Updated: July 23, 2013
Health Authority: United Kingdom: Research Ethics Committee
Spain: Ethics Committee

Keywords provided by DePuy International:
Arthroplasty
Replacement
Knee
PFC Sigma RPF
PFC Sigma RP

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

ClinicalTrials.gov processed this record on April 23, 2014