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

  • End date
    Dec 28, 2032
  • participants needed
  • sponsor
    Zimmer Biomet
Updated on 28 October 2022
rheumatoid arthritis
joint reconstruction


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.


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.

Condition 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
Treatment Nexel Total Elbow
Clinical Study IdentifierNCT02469662
SponsorZimmer Biomet
Last Modified on28 October 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note