Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatments lcs complete duofix, lcs complete porocoat
Phase phase 4
Sponsor DePuy International
Start date September 2006
End date October 2009
Trial size 206 participants
Trial identifier NCT00733499, CT 05/28

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
102 patients
lcs complete duofix
Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces
(Active Comparator)
104 patients
lcs complete porocoat
Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces

Primary Outcomes

Measure
Difference in the Mean VAS Pain Score Between Subjects Receiving LCS Complete Duofix™ and Porocoat® Knee Systems at 6 Months.
time frame: 6 Months Post Surgery

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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 affect 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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by DePuy International.