ExploR™ Modular Radial Head Data Collection

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00521846
Study type	Observational
Source	Vanderbilt University Medical Center
Contact
Status	Active, not recruiting
Phase
Start date	August 2007
Completion date	August 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.