Actively Recruiting
Clinical Outcomes Study of the Nexel Total Elbow
Led by Zimmer Biomet · Updated on 2025-10-29
134
Participants Needed
11
Research Sites
1122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Outcomes Study of the Nexel Total Elbow
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 significantly affecting daily activities; post-traumatic lesions or bone loss causing elbow instability; ankylosed joints, including bilateral ankylosis not caused by active sepsis; advanced rheumatoid arthritis, post-traumatic or degenerative arthritis with severe pain; instability or loss of motion where joint or soft tissue damage prevents reliable osteosynthesis; acute comminuted articular fracture of elbow joint surfaces preventing less radical treatments.
- Patient is willing and able to complete scheduled follow-up evaluations as defined by the protocol.
- For retrospective patients: must have had a Nexel total elbow replacement between July 2013 and site initiation with available preoperative and operative data.
You will not qualify if you...
- Patient has an active or history of repeated local infection at the surgical site.
- Patient has a current major infection away from the surgical site.
- Patient has a history of prior sepsis.
- Patient suffers from paralysis or dysfunctional neuropathy at the elbow joint.
- Patient has significant dysfunction of the same side hand.
- Patient has excessive scarring near the surgical site that could prevent proper soft tissue coverage.
- Patient participates in daily activities causing significant stress to the implant such as heavy labor, twisting stress, or competitive sports.
- Patient is a prisoner.
- Patient is mentally incompetent or unable to understand study participation.
- Patient is a known alcohol or drug abuser.
- Patient is expected to be non-compliant.
- Patient is known to be pregnant.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Panorama Orthopedics and Spine Center
Golden, Colorado, United States, 80401
Actively Recruiting
2
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
Actively Recruiting
3
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
4
Campbell Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
5
Sydney Shoulder & Elbow, NSW
Sydney, New South Wales, Australia, 2067
Terminated
6
Coxa Hospital
Tampere, Finland
Actively Recruiting
7
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse, France
Terminated
8
Arcus Sportklinik
Pforzheim, Germany
Terminated
9
AO Mauriziano
Torino, Italy, 10128
Actively Recruiting
10
Amphia Ziekenhuis Breda
Breda, Netherlands
Active, Not Recruiting
11
Wrightington
Wigan, United Kingdom
Actively Recruiting
Research Team
R
Richard Marek
CONTACT
R
Ryan Boylan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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