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Sponsored by: |
DePuy International |
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Information provided by: | DePuy International |
ClinicalTrials.gov Identifier: | NCT00733369 |
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 |
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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. |
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 |
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PFC Sigma RP-F: Experimental
125 patients to be allocated to this arm according to blinding envelopes
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Device: PFC Sigma RPF
An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing
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PFC Sigma RP: Active Comparator
125 patients to be allocated to this arm according to blinding envelopes
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Device: PFC Sigma RP
An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing
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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)
Ages Eligible for Study: | 45 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mick Borroff, BSc, MSc | +44 113 387 7800 ext 7910 | mborroff@dpygb.jnj.com |
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 |
Principal Investigator: | Francisco Macule, FRCS | Hospital Clinic i Provincial de Barcelona |
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 |
Arthroplasty Replacement Knee PFC Sigma RPF PFC Sigma RP |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |