What this study is
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.
What's being tested
- Nexel Total Elbow
Intervention · DEVICE
Nexel Total Elbow used in primary or revision total elbow arthroplasty
Study details
- Official title
- Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow
- Sponsor
- Zimmer Biomet
- Conditions
- Elbow Joint Destruction · Post-traumatic Lesions · Ankylosed Joints · Advanced Rheumatoid Arthritis · 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 · Post-traumatic Arthritis · Degenerative Arthritis
- Enrolling
- 134 people
- Starts
- 2015-06
- Est. completion
- 2036-12
- Design
- Open-label, non-randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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. Additional Retrospective Arm
- 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
7 openPanorama Orthopedics and Spine Center
Golden, Colorado, United States
- Paul Lee · ContactPaul.Lee@panoramaortho.com
- David Schneider, MD · Principal investigator
RecruitingOrthoCarolina Research Institute
Charlotte, North Carolina, United States
- Caleb Lifsey · Contact704-323-2262Caleb.Lifsey@orthocarolina.com
- Justin Norwood · Contact704-323-3845Justin.Norwood@orthocarolina.com
- Nady Hamid, MD · Principal investigator
- Patrick Connor, MD · Sub-investigator
RecruitingRothman Institute
Philadelphia, Pennsylvania, United States
- Anuhya Peruri · Contact267-386-2474Anuhya.Peruri@rothmanortho.com
- Thema Nicholson · Contactthema.nicholson@rothmaninstitute.com
- Surena Namdari, MD · Principal investigator
- Matthew Ramsey, MD · Sub-investigator
RecruitingCampbell Clinic
Germantown, Tennessee, United States
- Margaret Knack · Contactmknack@campbell-foundation.org
- Thomas W Throckmorton, MD · Principal investigator
Recruiting
7 sites outside the US
Coxa Hospital
Tampere, Finland
- Pirjo Honkanen, MD · Principal investigator
RecruitingAO Mauriziano
Torino, Italy
- Davide Blonna · Contact+39 011 508 1111davide.blonna@virgilio.it
- Davide Blonna, MD · Principal investigator
RecruitingWrightington
Wigan, United Kingdom
- Adam Watts, MBBS · Principal investigator
RecruitingSydney Shoulder & Elbow, NSW
Sydney, New South Wales, Australia
TerminatedHôpital Purpan (Centre Hospitalier Universitaire Toulouse)
Toulouse, France
TerminatedArcus Sportklinik
Pforzheim, Germany
TerminatedAmphia Ziekenhuis Breda
Breda, Netherlands
Active, not recruiting
Study team
Sponsor
Zimmer Biomet
Study ID CMU2014-06E
Study director
Hillary Overholser, MS
Zimmer Biomet
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.