Clinical trial NCT00533234: ExploR® Modular Radial Head Data Collection
Official title: ExploR® Modular Radial Head Data Collection
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be implanted with the ExploR® Modular Radial Head.

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.

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 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.

Primary outcomes:
measure: Mayo Clinic Performance Index for The Elbow, Quick DASH Outcome Measure, Radiographic Evaluation
timeFrame: 5 years
Secondary outcomes:
measure: Revisions, Complications, Adverse Events
timeFrame: 5 years
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Biomet Orthopedics, LLC
state: Indiana
Study officials:
affiliation: Biomet Orthopedics, LLC
name: Ken Beres, MD
role: PRINCIPAL_INVESTIGATOR
References: