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Study of the Nexel Total Elbow for Elbow Joint Conditions

This study is looking at the safety and performance of the Zimmer Nexel Total Elbow. This device is used in surgery to replace part or all of your elbow joint (total elbow arthroplasty), either for the first time or to revise a previous surgery. You might be able to join if you are 18 or older and have elbow joint destruction that affects your daily life, or other conditions like post-traumatic lesions, stiff joints (ankylosed joints), severe rheumatoid arthritis, or joint instability. The study will check how well the device works over 10 years by looking at pain, function, and if the device stays in place. The current status of this study is unclear.

Study design
This study plans to enroll 134 participants. It is an interventional study, meaning participants will receive the Nexel Total Elbow device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for 10 years to measure how long the device lasts (survivorship).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02469662

Clinical Outcomes Study of the Nexel Total Elbow

Recruiting
NAAges 18+InterventionalTreatment
Zimmer Biomet
~134 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Nexel Total Elbow

At a glance

Recruiting sites
7 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survivorship
Measured over 10 years

Conditions

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

Explore related trials

Ankylosed JointsElbow FractureElbow Joint DestructionInstability of jointOsteoarthritisPost-traumatic LesionsRheumatoid Arthritis

Where it's being run

11 sites across 11 states
Colorado1
North Carolina1
Pennsylvania1
Tennessee1
New South Wales1
Finland1
France1
Germany1

Study leadership

  • Hillary Overholser, MS · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

Richard Marek
[email protected]
574-453-7567
Email the study team

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Eligibility criteria

Inclusion

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.
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

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.

What this trial measures

  • Survivorship10 years

    Based on removal or intended removal of the device and determined using the Kaplan-Meier method