Clinical Outcomes Study of the Nexel Total Elbow
Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study checks the safety and performance of the Zimmer Nexel Total Elbow implant. It is for adults having their first total elbow replacement or surgery to replace an earlier elbow implant.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older and have signed an approved form agreeing to join the study.
- You need an elbow replacement for at least one of the problems listed below.
- Your elbow damage greatly limits daily tasks, or injury-related damage or bone loss makes your elbow unstable.
- Your elbow is stuck and cannot move for a reason other than an active serious infection.
- You have severe arthritis with pain that keeps you from doing daily tasks.
- Your elbow is unstable or hard to move and cannot be reliably repaired, or you have a new elbow joint break into many pieces that needs replacement.
- You are willing and able to attend the planned follow-up visits.
- For the group looking at past surgeries: you received a Nexel elbow replacement between July 2013 and your study site's start visit. Records must include personal details and an exam from before surgery, the surgery report, and implant details.
Who can't join
- You have an active infection or repeated past infections at the surgery site, a current major infection elsewhere, or past sepsis (a serious infection affecting the body).
- You have paralysis or nerve damage that affects elbow function, or major problems using the hand on the same side.
- You have too much scarring near the surgery site to allow enough tissue to cover the implant.
- Your daily activities put heavy stress on the implant, such as heavy work, twisting forces, or competitive sports.
- You are a prisoner.
- You cannot understand what joining the study involves or are expected not to follow study requirements.
- You are known to misuse alcohol or drugs.
- You are known to be pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (4)
CO
- Panorama Orthopedics and Spine Center · Golden, CO 80401Paul Lee · Study contact · Paul.Lee@panoramaortho.comDavid Schneider, MD · Principal investigatorMore trials in Golden
NC
- OrthoCarolina Research Institute · Charlotte, NC 28207Caleb Lifsey · Study contact · 704-323-2262 · Caleb.Lifsey@orthocarolina.comJustin Norwood · Study contact · 704-323-3845 · Justin.Norwood@orthocarolina.comNady Hamid, MD · Principal investigatorPatrick Connor, MD · Sub-investigatorMore trials in Charlotte
PA
- Rothman Institute · Philadelphia, PA 19107Anuhya Peruri · Study contact · 267-386-2474 · Anuhya.Peruri@rothmanortho.comThema Nicholson · Study contact · thema.nicholson@rothmaninstitute.comSurena Namdari, MD · Principal investigatorMatthew Ramsey, MD · Sub-investigatorMore trials in Philadelphia
TN
- Campbell Clinic · Germantown, TN 38138Margaret Knack · Study contact · mknack@campbell-foundation.orgThomas W Throckmorton, MD · Principal investigatorMore trials in Germantown