Evaluating the Nexel Total Elbow for joint replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Coxa Hospital
  Tampere, Finland Recruiting
• AO Mauriziano
  Torino, Italy Recruiting

Study contacts

• Study coordinator: Richard Marek
• Email: richard.marek@zimmerbiomet.com
• Phone: 574-453-7567

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Legion Medial Stabilized insert in total knee replacement

  This study tests whether the Legion Medial Stabilized insert is safe and works well when used in primary knee replacements for people with osteoarthritis, inflammatory arthritis, or post-traumatic arthritis.

  Recruiting at 3 sites Smith & Nephew, Inc. · Newton, Massachusetts and 3 other locations · NCT07199738

• Follow-up of the Incompass Total Ankle System after total ankle replacement surgery.

  The Incompass Total Ankle System will be followed to see if it is safe and helps reduce pain and improve quality of life in adults having total ankle replacement.

  Recruiting at 5 sites Stryker Trauma and Extremities · Morton Grove, Illinois and 4 other locations · NCT07118501

• Assessing the KeriFlex® silicone joint implant for arthritis treatment

  This study is testing how well the KeriFlex® silicone joint implant works and is safe for people with different types of arthritis who are getting joint replacement surgery.

  Recruiting at 3 sites Keri Medical SA · Besançon and 2 other locations · NCT06546345

• Observational study on total wrist replacement outcomes with KinematX implant

  This study is testing how well the KinematX wrist replacement helps people regain movement and strength in their wrist after surgery.

  Recruiting at 4 sites Extremity Medical · Loma Linda, California and 3 other locations · NCT05719935

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.