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Biomet Humeral Stem Data Collection

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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
Sponsor:
Information provided by:
Vanderbilt University

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

Condition or disease Intervention/treatment Phase
Humeral Stem Replacement Procedure: Humeral Stem replacement surgery Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
1
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.




Primary Outcome Measures :
  1. The outcome will be measured using the data collection sheets collected at each follow-up visit. [ Time Frame: 5 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553527


Locations
United States, Tennessee
Vanderbilt Hand Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Donald H Lee, MD Vanderbilt University Medical Center

Responsible Party: Dr. Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00553527     History of Changes
Other Study ID Numbers: 070144
First Posted: November 5, 2007    Key Record Dates
Last Update Posted: August 6, 2009
Last Verified: August 2009