A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low Contact Stress (LCS) Porocoat Knee Systems
This trial is active, not recruiting.
|Treatments||lcs complete duofix, lcs complete porocoat|
|Start date||September 2006|
|End date||October 2009|
|Trial size||206 participants|
|Trial identifier||NCT00733499, CT 05/28|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
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
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.
|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.|
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