MDR ExploR Radial Head System PMCF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ExploR Radial Head.
- Who it may be relevant to
- Registry conditions: Elbow Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device ExploR Radial Head
Patient must have undergone primary elbow arthroplasty with the ExploR Radial Head System according to a cleared indication.
Primary outcome measures
- Device Survivorship [Time frame: 10 years]
- Device Safety [Time frame: 10 years]
Secondary outcome measures (1)
- QuickDASH [Time frame: 1, 3, 5, 7, and 10 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Norton Healthcare — Louisville
Norway · 1 center
- Akershus University Hospital — Lørenskog
Identifiers
NCT: NCT05583448 · MDRG2017-89MS-77E