A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee
This study is ongoing, but not recruiting participants.
Sponsor:
DePuy International
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00733486
First received: August 11, 2008
Last updated: August 12, 2008
Last verified: August 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 11, 2008 | ||||
| Last Updated Date | August 12, 2008 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
A survival analysis of the LCS® Complete AP Glide knee prosthesis at five years. [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00733486 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Changes from baseline to each post-operative assessment in:Clinical outcome (stability, pain, range of motion and function), using the American Knee Society Score. [ Time Frame: 3 month, 1, 3, 5 and 7 years post operatively ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (APG) Mobile Bearing Knee | ||||
| Official Title ICMJE | A Prospective, Non-Comparative Study to Evaluate the Performance of the DePuy Low Contact Stress (LCS®) Complete Anterior-Posterior Glide (AP Glide) Mobile Bearing Knee System in Primary Knee Arthroplasty | ||||
| 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 to evaluate the clinical performance of the LCS® Complete AP Glide mobile bearing knee prosthesis and to determine its long-term survivorship. |
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| Detailed Description | Clinical and patient outcome secondary endpoints: changes in baseline to each post operative assessment in
Radiographic secondary endpoints: Assessment of component alignment, positioning and radiolucencies at all post operative time points. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||
| Intervention ICMJE | Device: L.C.S. APG Knee Anterior Posterior Glide knee
Orthopaedic implant for primary knee replacement |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | January 2015 | ||||
| Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 45 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00733486 | ||||
| Other Study ID Numbers ICMJE | CT 02/41 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mick Borroff, DePuy International (see above) | ||||
| Study Sponsor ICMJE | DePuy International | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | DePuy International | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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