Status:
COMPLETED
Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System
Lead Sponsor:
DePuy International
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.
Detailed Description
The secondary objective of this investigation is to evaluate the long-term survivorship and performance of the LCS Complete mobile-bearing total knee system and surgical instrumentation using the Amer...
Eligibility Criteria
Inclusion
- 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 mobile bearing knee system (LCS Complete).
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00733915
Start Date
March 1 2002
End Date
October 1 2014
Last Update
September 12 2025
Active Locations (1)
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1
Musgrave Park Hospital
Belfast, Ireland, BT9 7JB