NCT05583448
MDR ExploR Radial Head System PMCF
Enrolling by Invitation
Not specifiedAges 18+ObservationalZimmer Biomet
~93 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:ExploR Radial Head
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Survivorship
Measured over 10 years
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesKentucky1
Norway1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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
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.
What this trial measures
- Device Survivorship10 years
Measured by recording and analyzing the incidence and frequency of revisions, complications and adverse events. Survivorship is calculated with Kaplan Meier.
- Device Safety10 years
Assessed by recording frequency of adverse events during the length of the study.