A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low Contact Stress (LCS) Porocoat Knee Systems - Full Text View

Purpose

The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.

Condition	Intervention	Phase
Osteoarthritis	Device: LCS Complete Duofix Device: LCS Complete Porocoat	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, Randomised, Single Blinded Study Comparing the Pain, Biological Fixation and Outcomes of Patients With LCS Complete Duofix or LCS Porocoat Knee Systems

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:

Determination of a 35% difference in the mean VAS pain score between subjects recieving total knee arthroplasty with the LCS Complete Duofix™ and Porocoat® knee systems at 6 months. [ Time Frame: 6 Months Post Surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 12 months in terms of functional recovery using Oxford Knee Score [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 24 months in terms of functional recovery using Oxford Knee Score [ Time Frame: 24 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 60 months in terms of functional recovery using Oxford Knee Score [ Time Frame: 60 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 120 months in terms of functional recovery using Oxford Knee Score [ Time Frame: 120 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 12 months in terms of Quality of life using SF-12 Questionaire [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 24 months in terms of Quality of life using SF-12 Questionaire [ Time Frame: 24 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 60 months in terms of Quality of life using SF-12 Questionaire [ Time Frame: 60 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 120 months in terms of Quality of life using SF-12 Questionaire [ Time Frame: 120 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 12 months in terms of Zonal analysis of the tibial component [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 24 months in terms of Zonal analysis of the tibial component [ Time Frame: 24 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 60 months in terms of Zonal analysis of the tibial component [ Time Frame: 60 months post surgery ] [ Designated as safety issue: No ]
Comparative evaluation of variability between subjects recieving LCS Complete Duofix™ and Porocoat® knee systems in change from baseline to 120 months in terms of Zonal analysis of the tibial component [ Time Frame: 120 months post surgery ] [ Designated as safety issue: No ]
Survivorship analysis of the LCS Complete Duofix™ and Porocoat® knee systems [ Time Frame: 60 months post surgery ] [ Designated as safety issue: Yes ]
Survivorship analysis of the LCS Complete Duofix™ and Porocoat® knee systems [ Time Frame: 120 months post surgery ] [ Designated as safety issue: Yes ]

Enrollment:	204
Study Start Date:	June 2007
Estimated Study Completion Date:	November 2020
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LCS Complete Duofix 102 patients	Device: LCS Complete Duofix Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
Experimental: LCS Complete Porocoat 101 patients	Device: LCS Complete Porocoat Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces

Detailed Description:

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat knee system over 10 years.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Investigator, are able to understand this 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 idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with a cementless mobile bearing knee system (LCS Complete).
Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with both the investigational devices, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Subjects with a known history of poor compliance to medical treatment.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
Subjects involved in Medical-Legal claims.
Subjects who have participated in a clinical study with an investigational product in the last month.
Subjects who are currently involved in any injury litigation claims.
Revision of an existing knee implant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733499

Locations

Ireland
Musgrave Park Hospital
Belfast, Ireland, BT9 7JB

Sponsors and Collaborators

DePuy International

Investigators

Principal Investigator:

David Beverland, FRCS

Musgrave Park Hospital, Belfast

More Information

No publications provided

Responsible Party:	DePuy International
ClinicalTrials.gov Identifier:	NCT00733499 History of Changes
Other Study ID Numbers:	CT 05/28
Study First Received:	August 11, 2008
Last Updated:	February 20, 2013
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by DePuy International:

Arthroplasty, replacement, Knee, LCS Duofix, Porocoat

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013