X-3 Polyethylene Survival Outcomes Study
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First Received Date ICMJE | June 26, 2007 | ||||
Last Updated Date | September 28, 2012 | ||||
Start Date ICMJE | February 2007 | ||||
Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary efficacy parameter is the revision rate for total knee arthroplasty at 10 years post- surgery. [ Time Frame: 10 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00493792 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | X-3 Polyethylene Survival Outcomes Study | ||||
Official Title ICMJE | A Prospective, Randomized Study Comparing the Survival for X-3 Polyethylene to N2Vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System. | ||||
Brief Summary | A prospective, randomized, blinded clinical trial is proposed to compare Stryker Orthopaedics N2Vac Polyethylene to their X3 Polyethylene when used with the Triathlon Posterior Stabilized (PS) total knee system. |
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Detailed Description | This is a fixed-bearing knee intended for use in patients undergoing cemented total knee arthroplasty. The devices to be used are both FDA approved via 510k clearance. A total of 572 cases (286 per group) will be entered. Each patient will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary endpoint will be the revision rate at ten years. The result for these will be analyzed using an unconditional test of equivalence between two independent binomials. Chi-square analysis will be used to compare the instance of mortality, revision surgery, deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection. Other outcome measures incorporated in the Knee Society Clinical rating scale will undergo appropriate generalized linear regression for the type of outcome involved. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12 v1), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Device: Stryker X3 crosslink
Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years.
Other Name: Stryker X3 |
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Study Arm (s) |
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Publications * | |||||
* 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 | Recruiting | ||||
Estimated Enrollment ICMJE | 572 | ||||
Estimated Completion Date | January 2022 | ||||
Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Gender | Both | ||||
Ages | 21 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493792 | ||||
Other Study ID Numbers ICMJE | 06-003093, 06-003093 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Michael J. Stuart, M.D., Mayo Clinic Rochester | ||||
Study Sponsor ICMJE | Mayo Clinic | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Mayo Clinic | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |