Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT05415592
Eligibility Criteria:
Inclusion Criteria:
* Male or female - skeletally mature adult (aged 22 or older)
* Participant, who in the opinion of the Investigator, is able to understand the purpose of the study and is willing to return for all the required post-operative standard of care follow-up visits and have their data collected
* Participant who is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor
Any one of below:
* Primary replacement after fracture of the radial head
* Participant needing a partial radial head replacement for degenerative or post-traumatic conditions presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: i) joint destruction and/or subluxation visible on x-ray and/or ii. resistance to conservative treatment
* Symptomatic sequelae after radial head resection
* Revision following failed radial head arthroplasty
Exclusion Criteria:
* Dislocations of radius on ulna that would not allow a radio-humeral articulation
* Rheumatoid arthritis
* Infection, sepsis, and osteomyelitis
* Uncooperative participant or participant with neurologic disorders who is incapable of following directions, osteoporosis, metabolic disorders which may impair bone formation, osteomalacia, distant foci of infections which may spread to the implant site, rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Participants with limited life expectancy due to significant medical co-morbidity
* Presence of major vascular or major nerve injury (radial, ulnar, medial, musculocutaneous)
* Women who are pregnant or lactating
* Unable to comply with study requirements example, with maintaining follow-up
* Individuals currently involved in any personal injury litigation, medical-legal or worker's compensation claims
* Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months
* Demented or unable to provide informed consent
* Individuals, in the opinion of the Investigator, who are drug or alcohol abusers or have psychological disorders that could affect their ability to complete participant reported questionnaires or be compliant with follow-up requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05415592
Study Brief:
Protocol Section:
NCT05415592