Biomet Humeral Stem Data Collection

August 5, 2009 updated by: Vanderbilt University
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Hand Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Donald H Lee, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

November 1, 2007

First Submitted That Met QC Criteria

November 2, 2007

First Posted (Estimate)

November 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 5, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 070144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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