We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

ExploR™ Modular Radial Head Data Collection

This study is currently recruiting participants.
Verified January 2017 by Donald Lee, Vanderbilt University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521846
First Posted: August 28, 2007
Last Update Posted: January 26, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Donald Lee, Vanderbilt University Medical Center
  Purpose
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.

Condition Intervention
Elbow Fracture Device: Biomet Explor Modular Radial Head Replacement

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: ExploR™ Modular Radial Head Data Collection

Resource links provided by NLM:


Further study details as provided by Donald Lee, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • We will measure the performance and clinical outcomes of the ExploR Modular Radial Head based on data collection from the following forms: The Mayo Clinic Performance Index for The Elbow, The Quick DASH Outcome Measure, Radiographic Evaluation [ Time Frame: 5 years ]
  • Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant. [ Time Frame: Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year ]

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
As part of their routine care, patient's will receive Biomet modular radial head replacement. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes.
Device: Biomet Explor Modular Radial Head Replacement
As part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system.

Detailed Description:

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.

The radial head on which data will be collected is legally marketed and is not investigational or experimental. This data collection effort will document the clinical outcomes of the radial head.

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:

The Mayo Clinic Performance Index for The Elbow The Quick DASH Outcome Measure Radiographic Evaluation

All revisions, complications, and adverse events will also be recorded. Inclusion Criteria

Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

  1. Joint destruction and/or subluxation visible on x-ray
  2. Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty

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 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 Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be any individual that seeks care at Vanderbilt University Medical Center for a radial head fracture/dislocation that requires replacement using a Biomet Explor Modular Radial Head implant (routine care).
Criteria

Inclusion Criteria

Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

  1. Joint destruction and/or subluxation visible on x-ray
  2. Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty

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 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 Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed

  Contacts and Locations
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): NCT00521846


Contacts
Contact: Julie M Daniels, BBA 6153224506 Julie.M.Daniels@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232-8828
Contact: Julie M Daniels, BBA    615-322-4506    Julie.M.Daniels@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Donald H Lee, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Donald Lee, Professor of Orthopaedic Surgery, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00521846     History of Changes
Other Study ID Numbers: 070155
First Submitted: August 27, 2007
First Posted: August 28, 2007
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will not be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors