Biomet Humeral Stem Data Collection
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Biomet Humeral Stem Data Collection|
- The outcome will be measured using the data collection sheets collected at each follow-up visit. [ Time Frame: 5 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Patient will receive standard of care humeral stem replacement. Only a data collection study. There will be no changes in standard of care for diagnosis.
Procedure: Humeral Stem replacement surgery
Patient will receive humeral stem replacement.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00553527
|United States, Tennessee|
|Vanderbilt Hand Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Donald H Lee, MD||Vanderbilt University|