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

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

Radial Head Fractures

DePuy Synthes Radial Head Replacement System

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

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).

Number of participants with revision RHR surgery will be reported. Revision surgery
reasons include symptomatic aseptic loosening, elbow stiffness, persistent pain,
infection, elbow instability, overlengthening, dissociation of the prosthesis,
progressive symptomatic ulnohumeral degeneration, secondary fracture, heterotopic
ossification, osteoarthritis, erosions of the capitellum, or other implant-related
complications.

Mason classification system will be used for the classification of radial head fractures.
It includes four radial head fracture types. Mason Type I are non-displaced radial head
fractures (or small marginal fractures), Mason Type II are partial articular fractures
with displacement, Mason Type III are comminuted fractures involving the entire radial
head, and Mason Type IV are fractures of the radial head with dislocation of the elbow
joint.

Radiolucency will be assessed based on the number of zones involved and the amount of
lucency (in millimeters) observed. Radiolucency is classified as: a) None; b) Mild: one
or two zones involved by lucent lines of less than (<) 2 millimeters (mm) in thickness;
c) Moderate: three to six zones involved or the lucency of greater than or equal to (>=)
2 mm in thickness and d) Severe: all seven zones involved.

Radiocapitellar alignment will be determined. The position of the radial head prosthesis
is assessed on a lateral X-ray based on the intersection between the axis of the
prosthetic shaft and the center of the capitellum. The calculation is based on the
quotient of the diameter of the trochlea humeri and the axis of the prosthesis.

Ulnohumeral degeneration will be assessed. The degree of ulnohumeral degeneration is
classified with the system described by Broberg and Morrey as Grade 0 (normal joint),
Grade 1 (slight joint space narrowing with minimum osteophyte formation), Grade 2
(moderate joint space narrowing with moderate osteophyte formation) or Grade 3 (severe
degenerative changes with gross destruction of the joint).

Osteoarthritis (in the radio-capitellar joint) will be assessed. Osteoarthritis is
evaluated as yes/no, if yes, the location will be described (that is., medial, lateral or
both).

Heterotopic ossification will be determined and reported. Heterotopic ossification is
classified as present (that is, anterior-posterior, medial-lateral) or absent.

Osteopenia, and/or capitellar abrasion will be determined and reported. Capitellar
osteopenia and/or abrasion is classified as none, mild, moderate, or severe.

Overlengthening will be determined and reported. Overlengthening is assessed on the
intra- or postoperative, 6-, 12- and 24 months Antero-Posterior (AP) and lateral X-rays
(evidence of overstuffing).

Joint incongruity will be determined and reported. Joint incongruity is assessed as
yes/no.

MEPI is also known as Mayo Elbow Performance Score (MEPS). MEPI is used to evaluate the
clinical outcomes for a variety of elbow disorders such as elbow fractures and
dislocations. The MEPI is a validated hundred-point system based upon pain (forty five
points), range of motion (twenty points), stability (ten points) and daily function
(twenty five points) The scale ranges from 0 to 100, with a higher score indicating a
better outcome.

QuickDASH questionnaire has 30-items, which includes 21 items for physical function, 6
for symptoms, and 3 for social roles. Quick DASH is a shorter version, developed for less
burden to the responder. It consists of 11 items out of the original 30 questions of the
DASH. QuickDASH is scored between 0 (no disability) to 100 (most severe disability), with
lower scores indicating better overall wellness.

Elbow ROM of both sites (injured side and contralateral side) will be assessed according
to standard of care practices for elbow flexion, elbow extension, forearm supination, and
forearm pronation.

The grip strength (if available) will be assessed with dynamometer following the
standardized testing protocol recommended by the American Society of Hand Therapists
(ASHT). For measurements, the participants would be in a comfortable sitting position in
a chair without arm rests, with feet fully resting on the floor, hips as far back in the
chair as possible, and the hips and knees positioned at approximately 90 degrees. Grip
force should be applied smoothly, without rapid wrenching or jerking motion. (No
correction for hand dominance will be performed because this effect varies substantially
among users. Assessment will be also performed on the unaffected side using the same
method.

EQ-5D-5L questionnaire includes five questions (descriptive system: mobility, self-care,
usual activities, pain/discomfort, and anxiety/depression) and a visual analog scale to
rate the current health status. The resulting scores were converted into a single index
score that ranged from -0.281 to 1, where higher score indicates better health. Values
lower than 0 represent states considered to be worse than death.

Local pain intensity levels over the previous 24 hours will be assessed with the
Numerical Rating Scale (NRS). The scale range goes from 0 (no pain) to 10 (worst
imaginable pain). A higher value correlates with greater pain.

Number of participants who return to work and Sport will be assessed as yes/no.

Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs
(including abnormal laboratory findings) in participants, users or other persons, whether
or not related to investigational medical device, the Radial Head Replacement System, and
whether anticipated or unanticipated.

SAEs are defined as any device and or procedure related adverse event that: 1. Led to
death; 2. Serious deterioration in the health of the subject, that resulted in any of the
following: a. life-threatening illness or injury, b. permanent impairment of a body
structure or a body function, c. hospitalization or prolongation of existing
hospitalization, d. medical or surgical intervention to prevent life-threatening illness
or injury or permanent impairment to a body structure or a body function, e. chronic
disease; 3. Led to fetal distress, fetal death or a congenital physical or mental
impairment or birth defect.

Number of participants with revision/reoperation will be reported. A revision is
considered to be any procedure that involves removal of the implant (that is, removal of
the RHP, replacement with another RHP or revision surgery to a total elbow arthroplasty).
Reoperation is defined as a second operation involving the DePuy Synthes Radial Head
Replacement System at the index site and after the index surgery that does not include
removal or replacement of the implanted Radial Head Prosthesis.

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

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

About this trial

Study ID

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Type

Placebo

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Trial Timing

What is this trial about?

What are the participation requirements?

Locations

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