ExploR™ Modular Radial Head Data Collection

Elbow Fracture Clinical Trial

Official title:

ExploR™ Modular Radial Head Data Collection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00521846
• Other study ID #: 070155
• Status: Active, not recruiting
• Start date: August 2007
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elbow Fracture
• Elbow Fractures

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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