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

NCT05415592 | Withdrawn FDA Device

• 1 other identifier: DST202002
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Radial Head Fractures

Keywords

Radial Head Replacement; Radial Head Prosthesis; DePuy Synthes,; Partial Elbow Replacement; Device Survivorship

Outcome Measures

Primary Outcomes (1)

• Device survivorship Over the First 6 Months Post-implantation

  Device survivorship is defined by the cumulative incidence of absence of revision. A revision is considered to be any procedure that involves removal of the implant (that is, removal of the Radial Head Prosthesis \[RHP\], replacement with another RHP or revision surgery to a total elbow arthroplasty).

  6 months post-implantation

Secondary Outcomes (20)

• Number of Participant with Revision Radial Head Replacement (RHR) Surgery

  Up to 4 years post surgery

• Assessment of Radiographic Parameters: Mason Classification of Radial Head Fractures

  Preoperative, Operative, Discharge (up to Day 6)

• Assessment of Radiographic Parameters: Radiolucency

  At Months 6, 12, and 24

• Assessment of Radiographic Parameters: Radiocapitellar Alignment

  Operative at Week 2, and 6, Months 3, 6, 12, 24, and 48 post operative

• Assessment of Radiographic Parameters: Ulnohumeral Degeneration

  Operative at Week 2, and 6, Months 3, 6, 12, 24, and 48 post operative

Study Arms (1)

DePuy Synthes Radial Head Replacement System

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

Device: DePuy Synthes Radial Head Replacement System

Interventions

DePuy Synthes Radial Head Replacement System DEVICE

DePuy Synthes Radial Head Replacement System will be used for radial head replacement or partial replacement of the elbow joint.

DePuy Synthes Radial Head Replacement System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include skeletally mature adult participants aged 22 or older who are scheduled to undergo radial head replacement.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DePuy Synthes Products, Inc.: lead

Study Sites (4)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Slocum Research & Education Foundation

Eugene, Oregon, 97401, United States

Location

Inova Orthopaedics - Fairfax

Falls Church, Virginia, 22042, United States

Location

Glasgow Royal Infirmary (NHS Greater Glasgow & Clyde)

Glasgow, G40SF, United Kingdom

Location

Related Publications (31)

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MeSH Terms

Conditions

Radial Head and Neck Fractures

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Radius Fractures; Forearm Injuries; Fractures, Bone

Study Officials

• DePuy Synthes Products, Inc. Clinical Trial

  DePuy Synthes Products, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 13, 2022
• Study Start: March 31, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2030
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); GB (1)