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
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