ExploR® Modular Radial Head Data Collection

Degenerative Conditions of the Radial Head/Neck Clinical Trial

Official title:

ExploR® Modular Radial Head Data Collection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00533234
• Other study ID #: 116-U-001
• Status: Terminated
• Phase: N/A
• First received: September 20, 2007
• Last updated: June 19, 2017
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• 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. This data collection effort will document the clinical outcomes of the radial head.

Description:

Data collection intervals are:

Pre-operative, Operative, 3 Months Post-op, 1 Year Post-op, 3 Years Post-op, and 5 Years Post-op.

Data collected includes:

Historical data, Operative record, Mayo Clinic Performance Index for the Elbow, Quick DASH Outcome Measure, Complications, Lost to Follow-up, Protocol Deviations, and Radiographic evaluation of elbow and wrist.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The inclusion criteria will be the same as the indications stated in the FDA cleared (510(k) K040611) and (510(k) K051385) labeling for the device.

1. 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

2. Primary replacement after fracture of the radial head

3. Symptomatic sequelae after radial head resection

4. 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.

Exclusion Criteria:

The exclusion criteria will be the same as the contraindications stated in the FDA cleared labeling (510(k) K040611) and (510(k) K051385) for the device. These contraindications include:

Absolute contraindications:

1. Infection

2. Sepsis

3. Osteomyelitis

Relative contraindications:

1. Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions

2. Osteoporosis

3. Metabolic disorders which may impair bone function

4. Osteomalacia

5. Distant foci of infections which may spread to the implant site

6. Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Related Conditions & MeSH terms

• Degenerative Conditions of the Radial Head/Neck
• Disease
• Post-traumatic Conditions of the Radial Head/Neck

Intervention

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

Locations

Country	Name	City	State
United States	Biomet Orthopedics, LLC	Warsaw	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation		5 years
Secondary	Revisions, Complications, Adverse Events		5 years