Elbow Joint DestructionNCT02469662
Clinical Outcomes Study of the Nexel Total Elbow
A study testing Nexel Total Elbow in people with Elbow Joint Destruction and Post-traumatic Lesions, run by Zimmer Biomet at 11 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elbow Joint Destruction, Post-traumatic Lesions, Ankylosed Joints
- What is being tested?
- Nexel Total Elbow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 11 sitesin 8 countries
- Study dates
- Jun 2015to Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 8 countries
United States4 sites, 4 recruiting
- Recruiting
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Caleb Lifsey, 704-323-2262, Caleb.Lifsey@orthocarolina.com
Justin Norwood, 704-323-3845, Justin.Norwood@orthocarolina.com
- Recruiting
Campbell Clinic
Germantown, Tennessee, 38138
Margaret Knack, mknack@campbell-foundation.org
Thomas W Throckmorton, MD
- Recruiting
Panorama Orthopedics and Spine Center
Golden, Colorado, 80401
Paul Lee, Paul.Lee@panoramaortho.com
David Schneider, MD
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
Anuhya Peruri, 267-386-2474, Anuhya.Peruri@rothmanortho.com
Thema Nicholson, thema.nicholson@rothmaninstitute.com
Australia1 site
- Terminated
Sydney Shoulder & Elbow, NSW
Sydney, New South Wales, 2067
France1 site
- Terminated
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse
Italy1 site, 1 recruiting
- Recruiting
AO Mauriziano
Torino, 10128
Davide Blonna, +39 011 508 1111, davide.blonna@virgilio.it
Davide Blonna, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Wrightington
Wigan
Adam Watts, MBBS
About this study
Official title: 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.
Read the 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.
- 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
- Being tested
- Nexel Total Elbow
- Keywords
- Total Elbow Arthroplasty, TEA, Elbow Arthroplasty, Elbow Replacement, Advanced Rheumatoid Arthritis, Post-Traumatic Arthritis, Degenerative Arthritis, Elbow Joint Destruction, Post-Traumatic Lesions or Bone Loss, Ankylosed Joints, Acute Comminuted Articular Fracture, Significantly compromises daily living activities, Joint or soft tissue damage, Precludes less radical procedures, 13-C3 fractures of the distal humerus
- Medical subject headings
- Ankylosis, Joint Instability, Osteoarthritis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexel Total ElbowDevice
Also called Nexel Elbow, Nexel
Nexel Total Elbow used in primary or revision total elbow arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Experimental | Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available Receives: Device: Nexel Total Elbow |
| Prospective | Experimental | Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow Receives: Device: Nexel Total Elbow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2035 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow Joint DestructionStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, MS, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469662
- Sponsor's protocol ID
- CMU2014-06E
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2015
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
- ClinicalTrials.gov ID
- NCT02469662
- Acronym / sponsor ID
- CMU2014-06E
- 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
- Keywords
- Total Elbow Arthroplasty, TEA, Elbow Arthroplasty, Elbow Replacement, Advanced Rheumatoid Arthritis, Post-Traumatic Arthritis, Degenerative Arthritis, Elbow Joint Destruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | Experimental | Device: Nexel Total ElbowPatients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available |
| Prospective | Experimental | Device: Nexel Total ElbowPatients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.
- Additional Retrospective Arm Inclusion Criteria
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nexel Total ElbowAlso: Nexel Elbow, NexelNexel Total Elbow used in primary or revision total elbow arthroplasty | Device | Prospective, Retrospective |
Primary outcome
Survivorship
Time frame: 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hillary Overholser, MS study director
Zimmer Biomet
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexel Total Elbow in people with Elbow Joint Destruction and Post-traumatic Lesions, run by Zimmer Biomet at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Australia, Finland, France, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard Marek (574-453-7567, richard.marek@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.