Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexel™ Total Elbow

Who is this study for? Patients who are candidates for primary or revision total elbow arthroplasty
What treatments are being studied? Nexel Total Elbow
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Panorama Orthopedics and Spine Center
RECRUITING
Golden
North Carolina
OrthoCarolina Research Institute
RECRUITING
Charlotte
Pennsylvania
Rothman Institute
RECRUITING
Philadelphia
Tennessee
Campbell Clinic
RECRUITING
Germantown
Other Locations
Australia
Sydney Shoulder & Elbow, NSW
TERMINATED
Sydney
Finland
Coxa Hospital
RECRUITING
Tampere
France
Hôpital Purpan (Centre Hospitalier Universitaire Toulouse)
TERMINATED
Toulouse
Germany
Arcus Sportklinik
TERMINATED
Pforzheim
Italy
AO Mauriziano
RECRUITING
Torino
Netherlands
Amphia Ziekenhuis Breda
ACTIVE_NOT_RECRUITING
Breda
United Kingdom
Wrightington
RECRUITING
Wigan
Contact Information
Primary
Richard Marek
richard.marek@zimmerbiomet.com
574-453-7567
Backup
Ryan Boylan
ryan.boylan@zimmerbiomet.com
574-527-7934
Time Frame
Start Date: 2015-06
Estimated Completion Date: 2036-12
Participants
Target number of participants: 134
Treatments
Experimental: Retrospective
Patients who have had primary or revision total elbow arthroplasty using the Nexel Total Elbow, and who have surgical details available
Experimental: Prospective
Patients who are having primary or revision total elbow arthroplasty who will receive the Nexel Total Elbow
Authors
Sponsors
Leads: Zimmer Biomet

This content was sourced from clinicaltrials.gov