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New elbow implant under study for severe joint damage

NCT ID NCT02469662

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This study is looking at how well the Zimmer Nexel Total Elbow works for people who need elbow replacement surgery. It includes 134 adults with conditions like severe arthritis, fractures, or joint instability. The main goal is to see how long the implant lasts and if it is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zimmer Nexel Total Elbow device
What this could lead to
If successful, this could confirm that the Nexel Total Elbow is a safe and effective option for people needing elbow replacement surgery.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The device may still fail or cause complications like infection or implant loosening.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 134 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2015

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ankylosis Bone Diseases, Metabolic injury Joint Instability osteoarthritis rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute comminuted articular fracture of elbow joint surfaces Advanced rheumatoid arthritis Ankylosed joints Bilateral ankylosis from causes other than active sepsis Bone loss contributing to elbow instability Degenerative arthritis Elbow joint destruction Joint instability or loss of motion Post traumatic arthritis Post-traumatic lesions

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AO Mauriziano

    RECRUITING

    Torino, 10128, Italy

  • Amphia Ziekenhuis Breda

    ACTIVE_NOT_RECRUITING

    Breda, Netherlands

  • Arcus Sportklinik

    TERMINATED

    Pforzheim, Germany

  • Campbell Clinic

    RECRUITING

    Germantown, Tennessee, 38138, United States

  • Coxa Hospital

    RECRUITING

    Tampere, Finland

  • Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)

    TERMINATED

    Toulouse, France

  • OrthoCarolina Research Institute

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Panorama Orthopedics and Spine Center

    RECRUITING

    Golden, Colorado, 80401, United States

  • Rothman Institute

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Sydney Shoulder & Elbow, NSW

    TERMINATED

    Sydney, New South Wales, 2067, Australia

  • Wrightington

    RECRUITING

    Wigan, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.