A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint

DePuy Synthes

Status: Withdrawn

Conditions: Radial Head Fractures

Treatments: Device: DePuy Synthes Radial Head Replacement System

Study type: Observational

Funder types: Industry

Identifiers

NCT05415592

DST202002 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to establish survivorship defined by the cumulative incidence of revision over the first 6 months post-implantation.

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

DePuy Synthes Radial Head Replacement System

Description:

Participants will undergo a radial head replacement or partial replacement of the elbow joint with the DePuy Synthes Radial Head Replacement System.

Treatment:

Device: DePuy Synthes Radial Head Replacement System