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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

134

Phase

  • 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 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

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
Intervention / Treatment
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

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

Zimmer Biomet

Investigators

  • 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)

June 1, 2015

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimated)

June 11, 2015

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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