ExploR™ Modular Radial Head Data Collection

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00521846
First received: August 27, 2007
Last updated: August 5, 2014
Last verified: August 2014
  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: Explore Modular Radial Head

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: ExploR™ Modular Radial Head Data Collection

Further study details as provided by Vanderbilt University:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patient will receive modular radial head replacement. This is only a data collection study so this replacement is standard of care.
Device: Explore Modular Radial Head
Patient will receive a modular radial head replacement.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Donald H Lee, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Donald Lee, Professor of Orthopaedic Surgery, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00521846     History of Changes
Other Study ID Numbers: 070155
Study First Received: August 27, 2007
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014