ArCom® and ArComXL® Polyethylene Data Collection
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00565786 |
Recruitment Status
:
Active, not recruiting
First Posted
: November 30, 2007
Last Update Posted
: August 2, 2016
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Tracking Information | ||||
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First Submitted Date | November 28, 2007 | |||
First Posted Date | November 30, 2007 | |||
Last Update Posted Date | August 2, 2016 | |||
Study Start Date | July 2004 | |||
Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Polyethylene wear rates [ Time Frame: Duration of study ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT00565786 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | ArCom® and ArComXL® Polyethylene Data Collection | |||
Official Title | A Prospective Clinical Data Collection of ArCom® and ArComXL® Polyethylene | |||
Brief Summary | The purpose of this prospective clinical data-collection is to document the performance, clinical outcomes, and wear rates of ArCom® and ArComXL® Polyethylene. The data gathered will be collated and used as a part of Biomet's post-market surveillance system and to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies. Inclusion/exclusion criteria are identical to those indications and contraindications stated in the FDA approved labeling for the device in 510(k) K926107 and 510(k) K043051. Surgical techniques and patient care are to be standard for the surgeons participating in the protocol. |
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Detailed Description | The study follow-up intervals are 6 weeks, 1 year, 2 years, 3 years, 5 years, and 10 years. Demographic data is collected pre-operatively along with the Harris Hip Score and UCLA Activity Score. Operative information includes the surgical technique and other standard operative information. Follow-up information includes the Harris Hip Score, UCLA Activity Score, and Radiographic data. Anterior/posterior and frog leg lateral X-ray data is recorded to show radiolucencies, component position and angles. Sites are also required to send in an Anterior/Posterior Pelvis x-ray for wear analysis. Implant durability is documented by asking the surgeon to record revisions, complications, and device related adverse events. All information collected is de-identified in compliance with HIPAA regulations. | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | The study population will include patients requiring total hip replacement. | |||
Condition | Osteoarthritis of Hip | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* 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 | Active, not recruiting | |||
Actual Enrollment |
150 | |||
Original Actual Enrollment | Same as current | |||
Estimated Study Completion Date | March 2017 | |||
Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00565786 | |||
Other Study ID Numbers | ORTHO.CR.H011 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Zimmer Biomet ( Biomet Orthopedics, LLC ) | |||
Study Sponsor | Biomet Orthopedics, LLC | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Zimmer Biomet | |||
Verification Date | July 2016 |