NCT00553527

Biomet Humeral Stem Data Collection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.

Detailed description

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems. All stems on which data will be collected are legally marketed and none of the devices are investigational or experimental. This data collection effort will document the clinical outcomes of the humeral stems. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies. Inclusion/Exclusion criteria are within the indications and contraindications stated in the labeling, cleared by the FDA, for the device. Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational surgical techniques used. The devices and products are to be used in accordance with their instructions for use and/or approved labeling. The outcomes and data collected include: UCLA End-Result Score Radiographic Evaluation Survivorship will be documented by asking the surgeon to record revisions, complications, and device related events.

Conditions

• Humeral Stem Replacement

Interventions

Type	Name	Description
PROCEDURE	Humeral Stem replacement surgery	Patient will receive humeral stem replacement.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-11-05
• Last updated: 2009-08-06

Locations

1 site across 1 country: United States