Full Text View
Tabular View
No Study Results Posted
Related Studies
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 is currently recruiting participants.
Verified by DePuy International, April 2009
First Received: August 12, 2008   Last Updated: April 7, 2009   History of Changes
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00733369
  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 RPF
Device: PFC Sigma RP
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy 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.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Is the change from pre-operative range of motion at 1-year post operatively between subjects receiving primary total knee arthroplasty with the P.F.C. Sigma RP-F and P.F.C. RP Knee Systems. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparative evaluation of any post-operative variation between subjects receiving primary total knee arthroplasty with the P.F.C. Sigma RP-F and P.F.C. Sigma RP knee systems in change from baseline at each post operative time points in terms of: -·Knee a [ Time Frame: 3-6 months, 1, 2 and 5 years post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PFC Sigma RP-F: Experimental
125 patients to be allocated to this arm according to blinding envelopes
Device: PFC Sigma RPF
An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
PFC Sigma RP: Active Comparator
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 RPF

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

Contacts
Contact: Mick Borroff, BSc, MSc +44 113 387 7800 ext 7910 mborroff@dpygb.jnj.com

Locations
Spain
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain
Contact: Francisco Macule, FRCS     +34 (656) .31.40.53     fmacule@clinic.ub.es    
Principal Investigator: Francisco Macule, FRCS            
United Kingdom, Mersyside
Arrowe Park Hospital Recruiting
Wirral, Mersyside, United Kingdom
Contact: Robert A Harvey, FRCS     +44 151 678 5111        
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 - (see details above) ( Mick Borroff )
Study ID Numbers: CT 06/03
Study First Received: August 12, 2008
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00733369     History of Changes
Health Authority: United Kingdom: Research Ethics Committee;   Spain: Ethics Committee

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

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on August 26, 2009