RecruitingNot ApplicableNCT02469662

Clinical Outcomes Study of the Nexel Total Elbow

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


Sponsor

Zimmer Biomet

Enrollment

134 participants

Start Date

Jun 1, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking the long-term outcomes — such as pain relief, function, and complications — of patients who receive the Nexel Total Elbow replacement, an artificial joint used to treat severe elbow damage caused by arthritis, injury, or other conditions. **You may be eligible if...** - You are 18 years of age or older - You are having a total elbow replacement (first-time or repeat) due to severe arthritis, injury, joint instability, or fracture - Your elbow damage significantly affects your daily life and cannot be treated with less invasive procedures - You are willing and able to attend follow-up visits **You may NOT be eligible if...** - You have a current or repeated infection at or near the elbow joint - You have a history of blood poisoning (sepsis) - You have nerve damage or paralysis affecting the elbow - You have significant hand dysfunction on the same arm - You do heavy labor, high-stress physical activities, or competitive sports - You have excessive scarring near the elbow - You are pregnant - You are a known alcohol or drug abuser, or are likely to miss follow-up appointments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICENexel Total Elbow

Nexel Total Elbow used in primary or revision total elbow arthroplasty


Locations(11)

Panorama Orthopedics and Spine Center

Golden, Colorado, United States

OrthoCarolina Research Institute

Charlotte, North Carolina, United States

Rothman Institute

Philadelphia, Pennsylvania, United States

Campbell Clinic

Germantown, Tennessee, United States

Sydney Shoulder & Elbow, NSW

Sydney, New South Wales, Australia

Coxa Hospital

Tampere, Finland

Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)

Toulouse, France

Arcus Sportklinik

Pforzheim, Germany

AO Mauriziano

Torino, Italy

Amphia Ziekenhuis Breda

Breda, Netherlands

Wrightington

Wigan, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT02469662


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