- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00733915
Long-term Study of the DePuy Low Contact Stress (LCS) Complete Total Knee System
August 1, 2016 updated by: DePuy International
A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS) Complete Mobile-bearing Total Knee System.
The main objective of this study is to evaluate how the LCS Complete mobile-bearing total knee system and surgical instrumentation performs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 American Knee Society Score (AKS) the Oxford Knee Score (OKS), SF-12 and survivorship analysis.
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Belfast, Ireland, BT9 7JB
- Musgrave Park Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm
Cohort of total knee replacements with LCS Complete knee implants
|
L.C.S. Complete mobile-bearing total knee system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To demonstrate the surgical performance of the LCS Complete mobile-bearing total knee system and instrumentation using radiographic and intra-operative assessment
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To demonstrate the survivorship and performance of the LCS Complete mobile-bearing total knee system using the American Knee Society clinical and radiographic assessment, Oxford Knee Score, SF12 and survivorship analysis.
Time Frame: Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years
|
Pre surgery, surgery, 3 month, 1, 3, 5 and 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
August 11, 2008
First Submitted That Met QC Criteria
August 12, 2008
First Posted (Estimate)
August 13, 2008
Study Record Updates
Last Update Posted (Estimate)
August 2, 2016
Last Update Submitted That Met QC Criteria
August 1, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CT 01/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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