Biomet Humeral Stem Data Collection
|ClinicalTrials.gov Identifier: NCT00553527|
Recruitment Status : Terminated (Sponsor decided to terminate the project due to low multi-center enrollment.)
First Posted : November 5, 2007
Last Update Posted : August 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|Humeral Stem Replacement||Procedure: Humeral Stem replacement surgery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Biomet Humeral Stem Data Collection|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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 outcome will be measured using the data collection sheets collected at each follow-up visit. [ Time Frame: 5 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553527
|United States, Tennessee|
|Vanderbilt Hand Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Donald H Lee, MD||Vanderbilt University Medical Center|