MDR ExploR Radial Head System PMCF (NCT05583448) | Clinical Trial Compass
By InvitationNot Applicable
MDR ExploR Radial Head System PMCF
United States, Norway93 participantsStarted 2022-08-16
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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.