Clinical Outcomes Study of the Nexel Total Elbow

Recruiting now · Not applicable

Conditions studied: 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, Bone Loss Contributing to Elbow Instability, Bilateral Ankylosis From Causes Other Than Active Sepsis, Post-traumatic Arthritis, Degenerative Arthritis

In brief

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.

Key facts

Study ID: NCT02469662
Run by: Zimmer Biomet
People needed: 134
Starts: 2015-06-01
Expected to finish: 2036-12-01
Last updated by the study team: 2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 it is running

Wrightington — Wigan, United Kingdom (enrolling)
OrthoCarolina Research Institute — Charlotte, North Carolina, United States (enrolling)
Rothman Institute — Philadelphia, Pennsylvania, United States (enrolling)
Campbell Clinic — Germantown, Tennessee, United States (enrolling)
Coxa Hospital — Tampere, Finland (enrolling)
AO Mauriziano — Torino, Italy (enrolling)
Panorama Orthopedics and Spine Center — Golden, Colorado, United States (enrolling)
Arcus Sportklinik — Pforzheim, Germany
Sydney Shoulder & Elbow, NSW — Sydney, New South Wales, Australia
Amphia Ziekenhuis Breda — Breda, Netherlands
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse) — Toulouse, France

Full record on ClinicalTrials.gov

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