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ExploR® Modular Radial Head Data Collection

This study has been terminated.
(There was a lack of business need to continue this data collection.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00533234
First received: September 20, 2007
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Degenerative Conditions of the Radial Head/Neck
Post-traumatic Conditions of the Radial Head/Neck
 Device: ExploR® Modular Radial Head

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: ExploR® Modular Radial Head Data Collection

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Revisions, Complications, Adverse Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: December 2009
Study Completion Date: June 2010
Intervention Details:
    Device: ExploR® Modular Radial Head
    The ExploR® Modular Radial Head is a modular head and stem radial head/neck replacement.
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533234

Locations
United States, Indiana
Biomet Orthopedics, LLC
Warsaw, Indiana, United States, 46581
Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Principal Investigator: Ken Beres, MD Biomet Orthopedics, LLC
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier: NCT00533234     History of Changes
Other Study ID Numbers: 116-U-001
Study First Received: September 20, 2007
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Elbow fracture
Elbow dislocation
Radial head fracture
Radial neck fracture

ClinicalTrials.gov processed this record on May 16, 2013