Clinical Outcomes Study of the Nexel Total Elbow

Study Overview
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Brief Summary
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The objectives of the study are to confirm safety and performance of the Zimmer Nexel Total Elbow when used in primary or revision total elbow replacement.

Detailed Description
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The objectives of the study are to confirm safety and performance of the Zimmer® Nexel™ Total Elbow when used in primary or revision total elbow replacement by analysis of standard scoring systems, radiographs, and adverse event records. The safety of the device will be monitored using the frequency and incidence of reporting adverse events. The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.

Official Title
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Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

Conditions
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Elbow Joint Destruction, Post-traumatic Lesions, Ankylosed Joints, Advanced Rheumatoid Arthritis, Joint Instability or Loss of Motion, Acute Comminuted Articular Fracture of Elbow Joint Surfaces, Bone Loss Contributing to Elbow Instability, Bilateral Ankylosis From Causes Other Than Active Sepsis, Post-traumatic Arthritis, Degenerative Arthritis

Intervention / Treatment
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* Device: Nexel Total Elbow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years of age or older. Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent. Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of the following: Elbow joint destruction which significantly compromises daily living activities Post-traumatic lesions or bone loss contributing to elbow instability Ankylosed joints, especially cases of bilateral ankylosis from causes other than active sepsis Advanced rheumatoid arthritis, post-traumatic, or degenerative arthritis with incapacitating pain Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis Acute comminuted articular fracture of elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol. Additional Retrospective Arm Inclusion Criteria Patient must have undergone a total elbow replacement with the Nexel system between July 2013 and the date of the site initiation visit. Patient information available for each retrospective patient must, at minimum, include preoperative demographic information, preoperative physical exam information, the index surgery operative report, and details of the devices implanted. Exclusion Criteria: Patient has a currently active or history of repeated local infection at the surgical site. Patient has a current major infection distant from the operative site. Patient has a history of prior sepsis. Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint. Patient has significant ipsilateral hand dysfunction. Patient has excessive scarring near the surgical site, which could prevent adequate soft tissue coverage. Patient participates in daily activities that may cause significant stress to an implanted device such as heavy labor, torsional stress, and/or competitive sports. Patient is a prisoner. Patient is mentally incompetent or unable to understand what participation in the study entails. Patient is a known alcohol or drug abuser. Patient is anticipated to be non-compliant. Patient is known to be pregnant.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retrospective<br>Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available | Device: Nexel Total Elbow<br>* Nexel Total Elbow used in primary or revision total elbow arthroplasty<br>* Other names: Nexel;|
| Experimental: Prospective<br>Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow | Device: Nexel Total Elbow<br>* Nexel Total Elbow used in primary or revision total elbow arthroplasty<br>* Other names: Nexel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship | Based on removal or intended removal of the device and determined using the Kaplan-Meier method | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEA, Total Elbow Arthroplasty, Elbow Arthroplasty, Elbow Replacement, Advanced Rheumatoid Arthritis, Post-Traumatic Arthritis, Degenerative Arthritis, Elbow Joint Destruction, Post-Traumatic Lesions or Bone Loss, Ankylosed Joints, Acute Comminuted Articular Fracture, Significantly compromises daily living activities, Joint or soft tissue damage, Precludes less radical procedures, 13-C3 fractures of the distal humerus