MDR ExploR Radial Head System PMCF

Zimmer Biomet

Status: Invitation-only

Conditions: Elbow Injury

Treatments: Device: ExploR Radial Head

Study type: Observational

Funder types: Industry

Identifiers

NCT05583448

MDRG2017-89MS-77E

Details and patient eligibility

About

The objective of this retrospective and prospective consecutive series PMCF study is to collect long-term data confirming safety, performance and clinical benefits of the ExploR Radial Head System (implants and instrumentation) when used for radial head arthroplasty.

Full description

This is a global, multi-center, retrospective enrollment, prospective follow-up, consecutive series post-market clinical follow-up study. The intent of the study is that subjects who have already had the surgical implant will be retrospectively enrolled in the study and data will be collected for a minimum of 10 years post-operatively. Subjects treated with the device will be identified and invited to participate in the study. 93 subjects will be enrolled into the study.

Enrollment: 93 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication, which includes the following:

• 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 Patient must be 18 years of age or older. Patient must be willing and able to follow directions.

Exclusion criteria

• Infection
• Sepsis
• Osteomyelitis
• Uncooperative patient or patient with neurological disorders who are incapable of following directions
• Osteoporosis
• Metabolic disorders which may impair bone formation
• Osteomalacia
• Distant foci of infections which may spread to implant site
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
• Patient is a prisoner.
• Patient is a current alcohol or drug abuser.
• Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
• Patient is known to be pregnant or breastfeeding.
• Patient is unwilling to sign informed consent.

Trial design

93 participants in 1 patient group

ExploR Radial Head

Description:

Subjects who have received the ExploR Radial Head Device.

Treatment:

Device: ExploR Radial Head