ExploR® Modular Radial Head Data Collection

NCT00533234 | Terminated

• 1 other identifier: 116-U-001
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the ExploR® Modular Radial Head. This data collection effort will document the clinical outcomes of the radial head.

Conditions

Degenerative Conditions of the Radial Head/Neck; Post-traumatic Conditions of the Radial Head/Neck

Keywords

Elbow fracture; Elbow dislocation; Radial head fracture; Radial neck fracture

Outcome Measures

Primary Outcomes (1)

• Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation

  5 years

Secondary Outcomes (1)

• Revisions, Complications, Adverse Events

  5 years

Interventions

ExploR® Modular Radial Head DEVICE

The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be implanted with the ExploR® Modular Radial Head.

You may qualify if:

• 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:
• Joint destruction and/or subluxation visible on x-ray
• Resistance to conservative treatment
• Primary replacement after fracture of the radial head
• Symptomatic sequelae after radial head resection
• Revision following failed radial head arthroplasty
• The device is intended for single use with or without bone cement.
• Modular Radial Head replacement prostheses have received FDA clearance for cemented and non-cemented application.
• Patient selection factors to be considered include: 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, and 4) the patient must have reached full skeletal maturity.

You may not qualify if:

• Absolute contraindications:
• Infection
• Sepsis
• Osteomyelitis
• Relative contraindications:
• Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
• Osteoporosis
• Metabolic disorders which may impair bone function
• Osteomalacia
• Distant foci of infections which may spread to the implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Sponsors & Collaborators

• Biomet Orthopedics, LLC: lead

Study Sites (1)

Biomet Orthopedics, LLC

Warsaw, Indiana, 46581, United States

Location

MeSH Terms

Conditions

Elbow Fractures; Radial Head and Neck Fractures

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Radius Fractures; Forearm Injuries

Study Officials

• Ken Beres, MD

  Biomet Orthopedics, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Study Start: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

US (1)