Clinical Outcomes Study of the Nexel Total Elbow

Not Applicable

Recruiting

• Conditions: Post-traumatic Lesions; Post-traumatic Arthritis; Elbow Joint Destruction; Ankylosed Joints; 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; Advanced Rheumatoid Arthritis; Degenerative Arthritis
• Interventions: Device: Nexel Total Elbow

• Registration Number: NCT02469662
• Lead Sponsor: Zimmer Biomet

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2035-12
• Study Completion: 2036-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retrospective	Nexel Total Elbow	Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Prospective	Nexel Total Elbow	Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow

Primary Outcome Measures

Name	Time	Method
Survivorship	10 years	Based on removal or intended removal of the device and determined using the Kaplan-Meier method

Trial Locations

Locations (11)

Panorama Orthopedics and Spine Center; 🇺🇸 Golden, Colorado, United States

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States

Sydney Shoulder & Elbow, NSW; 🇦🇺 Sydney, New South Wales, Australia

Coxa Hospital; 🇫🇮 Tampere, Finland

Hôpital Purpan (Centre Hospitalier Universitaire Toulouse); 🇫🇷 Toulouse, France

Arcus Sportklinik; 🇩🇪 Pforzheim, Germany

AO Mauriziano; 🇮🇹 Torino, Italy

Amphia Ziekenhuis Breda; 🇳🇱 Breda, Netherlands

Wrightington; 🇬🇧 Wigan, United Kingdom