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ArCom® and ArComXL® Polyethylene Data Collection
This study is ongoing, but not recruiting participants.
Sponsor:
Biomet Orthopedics, LLC
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00565786
First received: November 28, 2007
Last updated: August 1, 2016
Last verified: July 2016
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | November 28, 2007 | |||
| Last Updated Date | August 1, 2016 | |||
| Start Date ICMJE | July 2004 | |||
| Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Polyethylene wear rates [ Time Frame: Duration of study ] | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | Complete list of historical versions of study NCT00565786 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
Harris Hip Score UCLA Activity Score [ Time Frame: Duration of study ] | |||
| 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 | ArCom® and ArComXL® Polyethylene Data Collection | |||
| Official Title ICMJE | 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 ICMJE | Observational | |||
| Study Design ICMJE | 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 ICMJE | Osteoarthritis of Hip | |||
| Intervention ICMJE |
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| Study Groups/Cohorts |
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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 | Active, not recruiting | |||
| Enrollment ICMJE | 150 | |||
| Estimated Completion Date | March 2017 | |||
| Estimated Primary Completion Date | November 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Senior | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00565786 | |||
| Other Study ID Numbers ICMJE | ORTHO.CR.H011 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Zimmer Biomet ( Biomet Orthopedics, LLC ) | |||
| Study Sponsor ICMJE | Biomet Orthopedics, LLC | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Zimmer Biomet | |||
| Verification Date | July 2016 | |||
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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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