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Clinical Outcomes Study of the Nexel Total Elbow

Sponsor: Zimmer Biomet

NCT ID: NCT02469662

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nexel Total Elbow (device)
How long the study runs
Study runs about 258 months (dates as stated)
About the drug or intervention
Nexel Total Elbow — device: Nexel Total Elbow used in primary or revision total elbow arthroplasty
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well the Nexel Total Elbow replacement works for people with serious elbow problems. These problems include badly damaged elbow joints, arthritis, stiff or fused joints, fractures, and instability. Zimmer Biomet, the company that makes the device, is running the study.

Who can take part

  • Adults aged 18 or over
  • People due to have a first or repeat full elbow replacement
  • Elbow problems such as joint damage affecting daily life, injury-related damage or bone loss, fused or stiff joints (especially both elbows), severe rheumatoid arthritis, injury-related or wear-and-tear arthritis with severe pain, instability or loss of movement, or a serious shattered fracture of the elbow joint surfaces
  • Able and willing to agree (give informed consent) and attend the study follow-up checks set out in the plan
  • For the retrospective (look-back) part: people who already had a Nexel elbow replacement since July 2013, with their past medical records available

Who may not be able to

  • Active or repeated infection at the elbow, or a major infection elsewhere in the body
  • Previous blood poisoning (sepsis)
  • Paralysis or nerve problems affecting the elbow, or poor use of the hand on the same side
  • Heavy scarring near the elbow that could stop proper healing
  • Daily activities that could stress the new joint a lot, such as heavy labour, twisting movements, or competitive sport
  • Being in prison
  • Being unable to understand what taking part means
  • Known alcohol or drug misuse, or being unlikely to follow the study plan
  • Known pregnancy

What taking part involves

  • • Surgery to replace the elbow joint with the Nexel Total Elbow device
  • • Attending follow-up checks as set out in the study plan — exact tests and timings: Not stated — ask the trial team

Time commitment: You would have elbow replacement surgery and attend scheduled follow-up checks; how many visits and how long the study lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
134
Started
2015-06
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for elbow joint destruction
  • • NA - 134 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with elbow joint destruction

Where?

  • • Wigan - Wrightington

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Elbow Joint DestructionPost-traumatic LesionsAnkylosed JointsAdvanced Rheumatoid ArthritisJoint Instability or Loss of MotionAcute Comminuted Articular Fracture of Elbow Joint SurfacesBone Loss Contributing to Elbow InstabilityBilateral Ankylosis From Causes Other Than Active SepsisPost-traumatic ArthritisDegenerative Arthritis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent

What the study is looking for

  • ✓Patient is 18 years of age or older.
  • ✓Patient must have signed Institutional Review Board (IRB)/Ethics Committee (EC)-approved agreement to take part.
  • ✓Patient is a candidate for primary or revision total elbow arthroplasty, based on symptoms including at least one of...
  • ✓Elbow joint destruction which significantly compromises daily living activities
  • ✓Post-traumatic lesions or bone loss contributing to elbow instability

Who cannot take part

  • ✗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.
See the full criteria
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.

Where Is This Study? (1 UK site)

Wrightington

Wigan, United Kingdom

Recruiting
Site contact (verified)
Adam Watts, MBBSPrincipal Investigator

How to Get in Touch

Richard Marek

Sponsor contact

CONTACT

574-453-7567 richard.marek@zimmerbiomet.com

Ryan Boylan

Sponsor contact

CONTACT

574-527-7934 ryan.boylan@zimmerbiomet.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07