LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | August 1, 2007 | ||||||||||||||||
| Last Updated Date | December 20, 2012 | ||||||||||||||||
| Start Date ICMJE | April 2007 | ||||||||||||||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Linear Wear Rates [ Time Frame: 5 Years Post-Surgery ] [ Designated as safety issue: No ] To evaluate the linear wear rates of X3® polyethylene inserts mated with LFIT™ Anatomic CoCr Femoral Heads at 5 years postoperative. It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00510458 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Clinical and Patient Outcomes [ Time Frame: 1, 3, and 5 Years Post-Surgery ] [ Designated as safety issue: No ] Evaluate the preoperative and postoperative cases for quality of life, clinical results and radiographic stability. Evaluate dislocation rates at 3 and 5 years postoperative. |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study | ||||||||||||||||
| Official Title ICMJE | LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts | ||||||||||||||||
| Brief Summary | Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||
| Study Population | Patients intending to undergo primary total hip arthroplasty with the LFIT device are invited by the investigator to participate in the study. |
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| Condition ICMJE | Hip Arthropathy | ||||||||||||||||
| Intervention ICMJE | Device: LFIT™ Femoral Heads With X3® Insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement |
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| Study Group/Cohort (s) | LFIT™Femoral Heads With X3® Insert
LFIT™ Femoral Heads With X3® Insert
Intervention: Device: LFIT™ Femoral Heads With X3® Insert |
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| 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 | 95 | ||||||||||||||||
| Estimated Completion Date | September 2016 | ||||||||||||||||
| Estimated Primary Completion Date | September 2016 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00510458 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 63 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Stryker Orthopaedics | ||||||||||||||||
| Study Sponsor ICMJE | Stryker Orthopaedics | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Stryker Orthopaedics | ||||||||||||||||
| Verification Date | December 2012 | ||||||||||||||||
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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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