Clinical Outcomes Study of the Nexel Total Elbow
Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
1 other identifier
interventional
134
8 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 8, 2015
CompletedFirst Posted
Study publicly available on registry
June 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2036
October 29, 2025
October 1, 2025
20.5 years
June 8, 2015
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method
10 years
Study Arms (2)
Retrospective
EXPERIMENTALPatients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Prospective
EXPERIMENTALPatients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Interventions
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Eligibility Criteria
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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (11)
Panorama Orthopedics and Spine Center
Golden, Colorado, 80401, United States
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207, United States
Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Campbell Clinic
Germantown, Tennessee, 38138, United States
Sydney Shoulder & Elbow, NSW
Sydney, New South Wales, 2067, Australia
Coxa Hospital
Tampere, Finland
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse, France
Arcus Sportklinik
Pforzheim, Germany
AO Mauriziano
Torino, 10128, Italy
Amphia Ziekenhuis Breda
Breda, Netherlands
Wrightington
Wigan, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hillary Overholser, MS
Zimmer Biomet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2015
First Posted
June 11, 2015
Study Start
June 1, 2015
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2036
Last Updated
October 29, 2025
Record last verified: 2025-10