Clinical trial NCT05583448: MDR ExploR Radial Head System PMCF
Official title: Post-market Clinical Follow-up Study of the ExploR™ Radial Head System (Implants and Instrumentation) - A Retrospective Enrollment/Prospective Follow-Up Consecutive Series Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Elbow Injury
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population should be a consecutive series of subjects implanted with the ExploR Radial Head System. The aim is to include 93 radial head arthroplasty procedures in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Survivorship
timeFrame: 10 years
measure: Device Safety
timeFrame: 10 years
Secondary outcomes:
measure: QuickDASH
timeFrame: 1, 3, 5, 7, and 10 years
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Lørenskog
country: Norway
facility: Akershus University Hospital
Study officials:
References: