R3® Acetabular System in Patients With Degenerative Hip Disease
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First Received Date ICMJE | August 6, 2010 | ||||||||||||||||||||||||||||||||
Last Updated Date | September 16, 2012 | ||||||||||||||||||||||||||||||||
Start Date ICMJE | October 2009 | ||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Effectiveness will be measured using the Harris Hip Score (HHS), The HOOS self assessment questionnaire, and radiographic assessment. Radiographic measures consist of radiolucencies, component position changes, and bony changes. [ Time Frame: 3 months, 1-5 years ] [ Designated as safety issue: Yes ] The objective of this study is to establish the safety and effectiveness of the R3 Acetabular System in primary total hip replacement. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT01407029 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Adverse Events [ Time Frame: Post Operative - 5 years ] [ Designated as safety issue: Yes ] All perioperative and postoperative device-related and surgical adverse events will be recorded during this study. |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||||
Brief Title ICMJE | R3® Acetabular System in Patients With Degenerative Hip Disease | ||||||||||||||||||||||||||||||||
Official Title ICMJE | A Prospective, Multicenter, Non-randomized, Clinical Outcomes Study of the R3® Acetabular System in Patients With Degenerative Hip Disease | ||||||||||||||||||||||||||||||||
Brief Summary | This is a prospective, non-randomized, consecutive series, multicenter clinical study that will include patients who will have total hip replacement with the R3 Acetabular System. |
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Detailed Description | The study design was selected to assess the safety and effectiveness profile of the R3 Acetabular System in patients with degenerative joint disease requiring primary total hip replacement. A non¬-randomized, consecutive series of up to 158 patients will be enrolled, and a maximum of 8 sites will participate in the study. Each site is allowed to enroll up to 22 patients. When 158 patients are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. The clinical data from this study will be compared with a historical control. The study will include follow up through 5 years. |
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Study Type ICMJE | Observational | ||||||||||||||||||||||||||||||||
Study Design ICMJE | Time Perspective: Prospective | ||||||||||||||||||||||||||||||||
Biospecimen | |||||||||||||||||||||||||||||||||
Sampling Method | Non-Probability Sample | ||||||||||||||||||||||||||||||||
Study Population | This clinical study can fulfill its objectives only if appropriate subjects are enrolled. All relevant medical and non-medical conditions should be taken into consideration when deciding whether a particular patient is suitable. |
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Condition ICMJE | Osteoarthritis | ||||||||||||||||||||||||||||||||
Intervention ICMJE | |||||||||||||||||||||||||||||||||
Study Group/Cohort (s) | |||||||||||||||||||||||||||||||||
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 | Active, not recruiting | ||||||||||||||||||||||||||||||||
Estimated Enrollment ICMJE | 158 | ||||||||||||||||||||||||||||||||
Estimated Completion Date | December 2014 | ||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | October 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 to 75 Years | ||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||
Location Countries ICMJE | United States | ||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT01407029 | ||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | R3H01 | ||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||||
Responsible Party | Smith & Nephew, Inc. | ||||||||||||||||||||||||||||||||
Study Sponsor ICMJE | Smith & Nephew, Inc. | ||||||||||||||||||||||||||||||||
Collaborators ICMJE | |||||||||||||||||||||||||||||||||
Investigators ICMJE |
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Information Provided By | Smith & Nephew, Inc. | ||||||||||||||||||||||||||||||||
Verification Date | April 2012 | ||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |