Evaluating the Nexel Total Elbow for joint replacement

Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

This study is testing the Zimmer Nexel Total Elbow replacement to see how well it works and if it's safe for people getting elbow surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zimmer Biomet (industry)
• Locations: 11 sites (Golden, Colorado and 10 other locations)
• Trial ID: NCT02469662 on ClinicalTrials.gov

What this trial studies

This study aims to confirm the safety and performance of the Zimmer Nexel Total Elbow in patients undergoing primary or revision total elbow replacement. It will analyze outcomes using standard scoring systems, radiographic assessments, and records of adverse events. The study will evaluate pain relief, functional performance, device survival, and overall patient health status following the procedure.

Who should consider this trial

Good fit: Ideal candidates include adults with significant elbow joint destruction, advanced rheumatoid arthritis, or other conditions leading to instability or loss of motion.

Not a fit: Patients with active infections or those who do not meet the criteria for total elbow arthroplasty may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide patients with improved pain management and functional outcomes following elbow replacement surgery.

How similar studies have performed: Other studies on total elbow arthroplasty have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility 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 this trial is running

Golden, Colorado and 10 other locations

• Panorama Orthopedics and Spine Center — Golden, Colorado, United States (RECRUITING)
• OrthoCarolina Research Institute — Charlotte, North Carolina, United States (RECRUITING)
• Rothman Institute — Philadelphia, Pennsylvania, United States (RECRUITING)
• Campbell Clinic — Germantown, Tennessee, United States (RECRUITING)
• Sydney Shoulder & Elbow, NSW — Sydney, New South Wales, Australia (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)

Study contacts

• Study coordinator: Richard Marek

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, Bone Loss Contributing to Elbow Instability, Bilateral Ankylosis From Causes Other Than Active Sepsis