ExploR™ Modular Radial Head Data Collection

NCT00521846 | Active Not Recruiting FDA Device

• 1 other identifier: 070155
• Study Type: observational
• Target: 50
• 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.

Conditions

Elbow Fracture

Outcome Measures

Primary Outcomes (2)

• 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

  5 years

• Patient examination measurements and radiographic measurements will be used to determine the effects of the Modular Radial Head implant.

  Pre-op, 6 week, 3 months, 6 months, 1 year, 2 year, 3 year, 4 year, 5 year

Study Arms (1)

1

As part of their routine care, patient's will receive Biomet modular radial head replacement. This study is an observational, prospective study that monitors the patient's pain, functional ability, and patient-reported outcomes.

Device: Biomet Explor Modular Radial Head Replacement

Interventions

Biomet Explor Modular Radial Head Replacement DEVICE

As part of the patient's routine care, they will undergo a radial head replacement using the Biomet Explor Modular Radial Head system.

1

Eligibility Criteria

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

Study Population

Study population will be any individual that seeks care at Vanderbilt University Medical Center for a radial head fracture/dislocation that requires replacement using a Biomet Explor Modular Radial Head implant (routine care).

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
• Patient selection factors to be considered:
• Need to obtain pain relief and improve function
• Ability and willingness of the patient to follow instructions, including control of weight and activity levels
• A good nutritional state of the patient
• The patient must have reached full skeletal maturity

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232-8828, United States

Location

MeSH Terms

Conditions

Elbow Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Donald H Lee, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)