Triathlon Total Stabilizer (TS) Outcomes Study
This study is currently recruiting participants.
Verified April 2013 by Stryker Orthopaedics
Sponsor:
Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00958789
First received: August 11, 2009
Last updated: April 12, 2013
Last verified: April 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 11, 2009 | ||||||||
| Last Updated Date | April 12, 2013 | ||||||||
| Start Date ICMJE | July 2009 | ||||||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To evaluate the change in outcomes from the preoperative time point to 2 years postoperative in cases implanted with the Triathlon® TS Total Knee System, with regard to both components of the Knee Society Score. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00958789 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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 | Triathlon Total Stabilizer (TS) Outcomes Study | ||||||||
| Official Title ICMJE | A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System | ||||||||
| Brief Summary | This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. When available, the Triathlon® TS Extended Condyle Femur (ECF) may also be included. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Arthropathy of Knee | ||||||||
| Intervention ICMJE | Device: Triathlon TS Knee System
Total knee replacement for revision cases
Other Name: Triathlon Total Stabilizer Knee System |
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| Study Arm (s) | Experimental: Triathlon TS Knee
Triathlon TS Knee System
Intervention: Device: Triathlon TS Knee System |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 181 | ||||||||
| Estimated Completion Date | July 2018 | ||||||||
| Estimated Primary Completion Date | July 2014 (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 |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00958789 | ||||||||
| Other Study ID Numbers ICMJE | 65 | ||||||||
| 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 | April 2013 | ||||||||
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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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