Biomet Humeral Stem Data Collection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Vanderbilt University

November 1, 2007
November 5, 2007
August 6, 2009
July 2007
July 2009   (Final data collection date for primary outcome measure)
The outcome will be measured using the data collection sheets collected at each follow-up visit. [ Time Frame: 5 year ]
Same as current
Complete list of historical versions of study NCT00553527 on Archive Site
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Biomet Humeral Stem Data Collection
Biomet Humeral Stem Data Collection
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.

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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Humeral Stem Replacement
Procedure: Humeral Stem replacement surgery
Patient will receive humeral stem replacement.
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.
Intervention: Procedure: Humeral Stem replacement surgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Dr. Donald Lee, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Donald H Lee, MD Vanderbilt University Medical Center
Vanderbilt University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP