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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
August 27, 2007
August 28, 2007
January 26, 2017
August 2007
August 2020   (Final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00521846 on ClinicalTrials.gov Archive Site
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ExploR™ Modular Radial Head Data Collection
ExploR™ Modular Radial Head Data Collection
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR Modular Radial Head.

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

Observational
Observational Model: Cohort
Time Perspective: Other
Not Provided
Not Provided
Non-Probability Sample
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).
Elbow Fracture
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.
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.
Intervention: Device: Biomet Explor Modular Radial Head Replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
August 2020
August 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Julie M Daniels, BBA 6153224506 Julie.M.Daniels@vanderbilt.edu
United States
 
 
NCT00521846
070155
No
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
Plan to Share IPD: No
Plan Description: Will not be shared.
Donald Lee, Vanderbilt University Medical Center
Vanderbilt University Medical Center
Not Provided
Principal Investigator: Donald H Lee, MD Vanderbilt University Medical Center
Vanderbilt University Medical Center
January 2017