Biomet Humeral Stem Data Collection
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Humeral Stem Replacement
Intervention: Humeral Stem replacement surgery (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Donald H Lee, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Julie M Daniels, BBA, Email: julie.m.daniels@vanderiblt.edu
Summary
The purpose of this prospective clinical data collection is to document the performance and
clinical outcomes of Biomet Humeral Stems.
Clinical Details
Official title: Biomet Humeral Stem Data Collection
Study design: Health Services Research, Non-Randomized, Open Label, Single Group Assignment
Primary outcome: The outcome will be measured using the data collection sheets collected at each follow-up visit.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular
necrosis
- Rheumatoid Arthritis
- Correction of functional deformity
- Patient selection factors to be considered:
1. Need to obtain pain relief and improve function
2. Ability and willingness of the patient to follow instructions, including control
of weight and activity levels
3. A good nutritional state of the patient
4. The patient must have reached full skeletal maturity
Exclusion Criteria:
- Patients who have infection, sepsis, and osteomyelitis
- Patients who are uncooperative or have neurologic disorders who is capable or
unwilling to follow directions
- Patients who have osteoporosis
- Patients who have metabolic disorders which may impair bone function
- Patients with osteomalacia
- Patients with distant foci of infections which may spread to the implant site
- Patients with rapid joint destruction, marked bone loss, or bone resorption apparent
on roentgenogram
- Patients who are pregnant
- Patients who are under 18 years of age
Locations and Contacts
Julie M Daniels, BBA, Email: julie.m.daniels@vanderiblt.edu
Vanderbilt Hand Center, Nashville, Tennessee 37232, United States; Recruiting
Additional Information
Starting date: July 2007
Ending date: July 2009
Last updated: February 4, 2009
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