Rejuvenate Modular Outcomes Study
This study is ongoing, but not recruiting participants.
Sponsor:
Stryker Orthopaedics
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT01257568
First received: December 8, 2010
Last updated: April 12, 2013
Last verified: April 2013
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | December 8, 2010 | ||||||||||||
| Last Updated Date | April 12, 2013 | ||||||||||||
| Start Date ICMJE | November 2010 | ||||||||||||
| Estimated Primary Completion Date | November 2022 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Survival Rate [ Time Frame: 5 years postoperative ] [ Designated as safety issue: No ] Evaluate the success rate of cementless primary THR with the Rejuvenate Modular Hip System as compared to the Secur-Fit HA monolithic femoral hip stem, through absence of revision at 5 years postoperative. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT01257568 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| 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 | Rejuvenate Modular Outcomes Study | ||||||||||||
| Official Title ICMJE | A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System | ||||||||||||
| Brief Summary | This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after 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 | Probability Sample | ||||||||||||
| Study Population | Patients eligible for Total Hip Replacement and meeting the Inclusion/Exclusion criteria at each investigative site will be invited to participate. |
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| Condition ICMJE | Arthroplasty, Replacement, Hip | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Rejuvenate Modular Hip System | ||||||||||||
| 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 | 240 | ||||||||||||
| Estimated Completion Date | November 2022 | ||||||||||||
| Estimated Primary Completion Date | November 2022 (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 | NCT01257568 | ||||||||||||
| Other Study ID Numbers ICMJE | 68 | ||||||||||||
| 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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