Actively Recruiting
Retrospective and Prospective Clinical Outcomes Study of the Zimmer Nexel Total Elbow for Primary or Revision Total Elbow Replacement
Led by Zimmer Biomet · Updated on 2025-10-29
134
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Zimmer Nexel Total Elbow device used in primary or revision total elbow replacement surgeries. The study aims to confirm these aspects by analyzing standard scoring systems, X-rays, and records of any adverse events. It focuses on conditions such as elbow joint destruction, post-traumatic lesions, arthritis, instability, and fractures that impact elbow function. The study includes two groups: patients who have already undergone elbow replacement using the Nexel Total Elbow and those scheduled to receive it. The device's safety is monitored by tracking adverse event frequency, while its performance is assessed by measuring pain, function, implant survival, patient health, and radiographic success. Both retrospective and prospective data are collected based on surgical details and follow-up evaluations. Participants will undergo scheduled follow-up visits to evaluate their pain levels, functional abilities, and elbow health through physical exams and imaging. Researchers will monitor device survival over 10 years and track any complications or adverse events. The total duration of participation varies depending on whether the patient is in the retrospective or prospective group, with ongoing assessments to ensure safety and performance.
CONDITIONS
Brief 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 has signed IRB/EC-approved informed consent.
- Patient is a candidate for primary or revision total elbow arthroplasty due to symptoms such as elbow joint destruction, post-traumatic lesions or bone loss, ankylosed joints, advanced rheumatoid or degenerative arthritis, instability or loss of motion, or acute comminuted articular fracture.
- Patient is willing and able to complete scheduled follow-up evaluations.
- For retrospective arm: Patient underwent total elbow replacement with the Nexel system between July 2013 and site initiation.
- Retrospective patient data includes preoperative demographics, physical exam, operative report, and implant details.
You will not qualify if you...
- Patient has active or repeated local infection at the surgical site.
- Patient has current major infection distant from the operative site.
- Patient has 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 preventing adequate soft tissue coverage.
- Patient participates in daily activities causing significant stress to the implant, such as heavy labor 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 anticipated to be non-compliant.
- Patient is known to be pregnant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants receive the Nexel Total Elbow device as part of primary or revision total elbow arthroplasty.
1 visit (in-person)
Duration - Up to 10 years
Participants are monitored for safety and performance of the implant through standard scoring systems, radiographs, and adverse event records.
Scheduled follow-up visits over 10 years
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
R
Ryan Boylan
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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