Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem
This study has been completed.
Sponsor:
Northern Orthopaedic Division, Denmark
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00192699
First received: September 11, 2005
Last updated: May 1, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2005 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | January 2004 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00192699 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 | Bimetric-10: Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-Metric Stem | ||||
| Official Title ICMJE | 10 Year Follow-up Investigation of Patients Who Have Underwent Total Hip Arthroplasty With a Cemented Bi-metric Stem | ||||
| Brief Summary | This is a 10 year follow-up investigation of patients who have underwent total hip arthroplasty with a cemented Bimetric stem. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with osteoarthrosis in hip who have underwent surgery for 10 years ago using Cemented Bi-Metric femoral stem. |
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| Condition ICMJE | Osteoarthrosis | ||||
| Intervention ICMJE | Device: Bimetric femoral stem
Cemented Bi-Metric femoral stem
Other Name: Cemented Bi-Metric femoral stem |
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| Study Group/Cohort (s) | Group 1: Cemented Bi-Metric femoral stem
Cemented Bi-Metric femoral stem
Intervention: Device: Bimetric femoral stem |
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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 | Completed | ||||
| Enrollment ICMJE | 80 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | April 2011 (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 | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00192699 | ||||
| Other Study ID Numbers ICMJE | ON-04-008b-JPE | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Northern Orthopaedic Division, Denmark | ||||
| Study Sponsor ICMJE | Northern Orthopaedic Division, Denmark | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Northern Orthopaedic Division, Denmark | ||||
| Verification Date | May 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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