Clinical trial NCT05415592: A Study of Participants Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
Official title: A Multi-Center, Post-Market, Single-Arm, Observational Clinical Follow-Up Study of Patients Undergoing Radial Head Replacement Using the DePuy Synthes Radial Head Replacement System for Partial Replacement of the Elbow Joint
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Radial Head Fractures
Keywords: Radial Head Replacement
Radial Head Prosthesis
DePuy Synthes,
Partial Elbow Replacement
Device Survivorship
Lead sponsor: DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Device survivorship Over the First 6 Months Post-implantation
timeFrame: 6 months post-implantation
Secondary outcomes:
measure: Number of Participant with Revision Radial Head Replacement (RHR) Surgery
timeFrame: Up to 4 years post surgery
measure: Assessment of Radiographic Parameters: Mason Classification of Radial Head Fractures
timeFrame: Preoperative, Operative, Discharge (up to Day 6)
measure: Assessment of Radiographic Parameters: Radiolucency
timeFrame: At Months 6, 12, and 24
measure: Assessment of Radiographic Parameters: Radiocapitellar Alignment
timeFrame: Operative at Week 2, and 6, Months 3, 6, 12, 24, and 48 post operative
measure: Assessment of Radiographic Parameters: Ulnohumeral Degeneration
timeFrame: Operative at Week 2, and 6, Months 3, 6, 12, 24, and 48 post operative
measure: Assessment of Radiographic Parameters: Osteoarthritis
timeFrame: At Week 2, and 6, Months 3, 6, 12, 24, and 48
measure: Assessment of Radiographic Parameters: Heterotopic Ossification
timeFrame: At Week 2, and 6, Months 3, 6, 12, 24, and 48
measure: Assessment of Radiographic Parameters: Osteopenia, and/or Capitellar Abrasion
timeFrame: At Week 2, and 6, Months 3, 6, 12, 24, and 48
measure: Assessment of Radiographic Parameters: Overlengthening
timeFrame: Operative at Months 6, 12, and 24 post operative
measure: Assessment of Radiographic Parameters: Joint incongruity
timeFrame: Operative at Week 2, and 6, Months 3, 6, 12, 24 and 48 post operative
measure: Mayo Elbow Performance Index (MEPI) Score
timeFrame: Week 2 and 6, Months 3, 6, 12, 24, and 48
measure: Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score
timeFrame: Week 2 and 6, Months 3, 6, 12, 24, and 48
measure: Elbow Range of Motion (ROM)
timeFrame: Week 2 and 6, Months 3, 6, 12, 24, and 48
measure: Grip Strength of the Injured Limb Compared to the Contralateral Side
timeFrame: At Week 6, Months 6, 12, 24 and 48
measure: European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scale Score
timeFrame: Preoperative, Week 6, Months 6, 12, 24, and 48
measure: Local Pain Assessed by Numerical Rating Scale (NRS) Score
timeFrame: Week 2 and 6, Months 3, 6, 12, 24, and 48
measure: Number of Participants who Return to Work and Sport
timeFrame: Week 2 and 6, Months 3, 6, 12, 24, 36 and 48
measure: Number of Participants with Device and/or Procedure-related Adverse Events (AEs)
timeFrame: Operative, Discharge (up to Day 6), Week 2, 6, Months 3, 6, 12, 24, 36, and 48
measure: Number of Participants with Device and/or Procedure-related Serious Adverse Events (SAEs)
timeFrame: Operative, Discharge (up to Day 6), Week 2, 6, Months 3, 6, 12, 24, 36, and 48
measure: Number of Participants with Revision/Reoperations
timeFrame: Operative, Discharge (up to Day 6), Week 2, 6, Months 3, 6, 12, 24, 36, and 48
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Eugene
country: United States
facility: Slocum Research & Education Foundation
state: Oregon
city: Falls Church
country: United States
facility: Inova Orthopaedics - Fairfax
state: Virginia
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary (NHS Greater Glasgow & Clyde)
Study officials:
affiliation: DePuy Synthes Products, Inc.
name: DePuy Synthes Products, Inc. Clinical Trial
role: STUDY_DIRECTOR
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