Clinical Outcomes Study of the Nexel Total Elbow

October 28, 2025 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2067
        • Terminated
        • Sydney Shoulder & Elbow, NSW
  • Finland
      • Tampere, Finland
        • Recruiting
        • Coxa Hospital
        • Principal Investigator:
          • Pirjo Honkanen, MD
  • France
      • Toulouse, France
        • Terminated
        • Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
  • Germany
      • Pforzheim, Germany
        • Terminated
        • Arcus Sportklinik
  • Italy
      • Torino, Italy, 10128
        • Recruiting
        • AO Mauriziano
        • Contact:
        • Principal Investigator:
          • Davide Blonna, MD
  • Netherlands
      • Breda, Netherlands
        • Active, not recruiting
        • Amphia Ziekenhuis Breda
  • United Kingdom
      • Wigan, United Kingdom
        • Recruiting
        • Wrightington
        • Principal Investigator:
          • Adam Watts, MBBS
  • United States
    • Colorado
      • Golden, Colorado, United States, 80401
        • Recruiting
        • Panorama Orthopedics and Spine Center
        • Principal Investigator:
          • David Schneider, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
    • Pennsylvania
    • Tennessee
      • Germantown, Tennessee, United States, 38138

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Retrospective
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
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Other Names:
  • Nexel Elbow
  • Nexel
Experimental: Prospective
Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Device: Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Other Names:
  • Nexel Elbow
  • Nexel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survivorship
Time Frame: 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zimmer Biomet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hillary Overholser, MS, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMU2014-06E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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