NCT00521846

ExploR™ Modular Radial Head Data Collection

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Elbow Fracture

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2007-08-28
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study