Status:
TERMINATED
A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-85 years
Phase:
PHASE4
Brief Summary
The primary objective of this investigation is to determine the survivorship of the LCS Complete AP Glide mobile bearing knee prosthesis at 5 years. The secondary objectives of this investigation are...
Eligibility Criteria
Inclusion
- Male or female subjects, aged between 45 and 85 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- Subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- Subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the LCS Complete AP Glide mobile bearing knee system, 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.
- Revision of an existing knee implant (including unicompartmental implants).
- Female subjects 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 who have participated in a clinical study with an investigational product in the last month (30 days).
- Subjects who are currently involved in any personal injury litigation claims.
- Subjects involved in personal Medical-Legal claims.
- Subjects with a known history of poor compliance to medical treatment.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00733486
Start Date
August 1 2005
End Date
February 1 2011
Last Update
June 9 2015
Active Locations (3)
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1
Dong-A University medical centre
Pusan, South Korea
2
Ewha Womans University Mokdong Hospital
Seoul, South Korea
3
Severance Hospital, Yongsei University College of Medicine
Seoul, South Korea