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

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

Official Title
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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

Conditions
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Radial Head Fractures

Intervention / Treatment
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* Device: DePuy Synthes Radial Head Replacement System


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DePuy Synthes Radial Head Replacement System<br>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<br>* DePuy Synthes Radial Head Replacement System will be used for radial head replacement or partial replacement of the elbow joint.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant with Revision Radial Head Replacement (RHR) Surgery | 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. | Up to 4 years post surgery | 
| Assessment of Radiographic Parameters: Mason Classification of Radial Head Fractures | 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. | Preoperative, Operative, Discharge (up to Day 6) | 
| Assessment of Radiographic Parameters: Radiolucency | 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. | At Months 6, 12, and 24 | 
| Assessment of Radiographic Parameters: Radiocapitellar Alignment | 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. | Operative at Week 2, and 6, Months 3, 6, 12, 24, and 48 post operative | 
| Assessment of Radiographic Parameters: Ulnohumeral Degeneration | 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). | Operative at Week 2, and 6, Months 3, 6, 12, 24, and 48 post operative | 
| Assessment of Radiographic Parameters: Osteoarthritis | 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). | At Week 2, and 6, Months 3, 6, 12, 24, and 48 | 
| Assessment of Radiographic Parameters: Heterotopic Ossification | Heterotopic ossification will be determined and reported. Heterotopic ossification is classified as present (that is, anterior-posterior, medial-lateral) or absent. | At Week 2, and 6, Months 3, 6, 12, 24, and 48 | 
| Assessment of Radiographic Parameters: Osteopenia, and/or Capitellar Abrasion | Osteopenia, and/or capitellar abrasion will be determined and reported. Capitellar osteopenia and/or abrasion is classified as none, mild, moderate, or severe. | At Week 2, and 6, Months 3, 6, 12, 24, and 48 | 
| Assessment of Radiographic Parameters: Overlengthening | 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). | Operative at Months 6, 12, and 24 post operative | 
| Assessment of Radiographic Parameters: Joint incongruity | Joint incongruity will be determined and reported. Joint incongruity is assessed as yes/no. | Operative at Week 2, and 6, Months 3, 6, 12, 24 and 48 post operative | 
| Mayo Elbow Performance Index (MEPI) Score | 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. | Week 2 and 6, Months 3, 6, 12, 24, and 48 | 
| Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) Score | 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. | Week 2 and 6, Months 3, 6, 12, 24, and 48 | 
| Elbow Range of Motion (ROM) | 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. | Week 2 and 6, Months 3, 6, 12, 24, and 48 | 
| Grip Strength of the Injured Limb Compared to the Contralateral Side | 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. | At Week 6, Months 6, 12, 24 and 48 | 
| European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scale Score | 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. | Preoperative, Week 6, Months 6, 12, 24, and 48 | 
| Local Pain Assessed by Numerical Rating Scale (NRS) Score | 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. | Week 2 and 6, Months 3, 6, 12, 24, and 48 | 
| Number of Participants who Return to Work and Sport | Number of participants who return to work and Sport will be assessed as yes/no. | Week 2 and 6, Months 3, 6, 12, 24, 36 and 48 | 
| Number of Participants with Device and/or Procedure-related Adverse Events (AEs) | 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. | Operative, Discharge (up to Day 6), Week 2, 6, Months 3, 6, 12, 24, 36, and 48 | 
| Number of Participants with Device and/or Procedure-related Serious Adverse Events (SAEs) | 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. | Operative, Discharge (up to Day 6), Week 2, 6, Months 3, 6, 12, 24, 36, and 48 | 
| Number of Participants with Revision/Reoperations | 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. | Operative, Discharge (up to Day 6), Week 2, 6, Months 3, 6, 12, 24, 36, and 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial Head Replacement, Radial Head Prosthesis, DePuy Synthes,, Partial Elbow Replacement, Device Survivorship