A Prospective Clinical Study On A Total Hip Resurfacing System
This study is ongoing, but not recruiting participants.
Sponsor:
Biomet, Inc.
Collaborator:
St. Anna Ziekenhuis, Geldrop, Netherlands
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00603395
First received: December 23, 2007
Last updated: February 11, 2012
Last verified: February 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 23, 2007 | ||||||||
| Last Updated Date | February 11, 2012 | ||||||||
| Start Date ICMJE | September 2004 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation [ Time Frame: 2 years postoperative ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00603395 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Complications [ Time Frame: Anytime ] [ Designated as safety issue: Yes ] | ||||||||
| 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 | A Prospective Clinical Study On A Total Hip Resurfacing System | ||||||||
| Official Title ICMJE | A Prospective Clinical Study On A Total Hip Resurfacing System | ||||||||
| Brief Summary | This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system. |
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| Study Arm (s) | ReCap
ReCap Total Hip Resurfacing System
Intervention: Device: ReCap Total Hip Resurfacing System |
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| Publications * | van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247. | ||||||||
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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 | 300 | ||||||||
| Estimated Completion Date | September 2017 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00603395 | ||||||||
| Other Study ID Numbers ICMJE | EU-6 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Biomet, Inc. | ||||||||
| Study Sponsor ICMJE | Biomet, Inc. | ||||||||
| Collaborators ICMJE | St. Anna Ziekenhuis, Geldrop, Netherlands | ||||||||
| Investigators ICMJE |
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| Information Provided By | Biomet, Inc. | ||||||||
| Verification Date | February 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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