A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Re… (NCT05415592) | Clinical Trial Compass
WithdrawnNot Applicable
A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
Stopped: This was a business decision made due to competing regulatory commitments. Please note that this was not related to the safety or performance of the device.
United States, United Kingdom0Started 2023-03-31
Plain-language summary
The purpose of this study is to establish survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation.
Who can participate
Age range22 Years
SexALL
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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 roentgenog…
What they're measuring
1
Device survivorship Over the First 6 Months Post-implantation