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Clinical Trials in the USA / NCT02469662
Recruiting Not applicable

Clinical Outcomes Study of the Nexel Total Elbow

NCT02469662 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2015-06
Last updated
2026-07-09

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Nexel Total Elbow

Nexel Total Elbow: Nexel Total Elbow used in primary or revision total elbow arthroplasty

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Panorama Orthopedics and Spine Center Golden Colorado Recruiting
OrthoCarolina Research Institute Charlotte North Carolina Recruiting
Rothman Institute Philadelphia Pennsylvania Recruiting
Campbell Clinic Germantown Tennessee Recruiting
Sydney Shoulder & Elbow, NSW Sydney New South Wales Terminated
Coxa Hospital Tampere Finland Recruiting
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse) Toulouse France Terminated
Arcus Sportklinik Pforzheim Germany Terminated
AO Mauriziano Torino Italy Recruiting
Amphia Ziekenhuis Breda Breda Netherlands Active Not Recruiting
Wrightington Wigan United Kingdom Recruiting

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02469662 on ClinicalTrials.gov ↗ ← All trials in the USA