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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02469662
Other study ID # CMU2014-06E
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date December 2032

Study information

Verified date April 2023
Source Zimmer Biomet
Contact Richard Marek
Phone 574-453-7567
Email richard.marek@zimmerbiomet.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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 by analysis of standard scoring systems, radiographs, and adverse event records. The safety of the device will be monitored using the frequency and incidence of reporting adverse events. The performance of the device will be evaluated by assessing the pain and functional performance, survival of the device, patient health status, and radiographic success of the implant.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 2032
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Nexel Total Elbow
Nexel Total Elbow used in primary or revision total elbow arthroplasty

Locations

Country Name City State
Australia Sydney Shoulder & Elbow, NSW Sydney New South Wales
Finland Coxa Hospital Tampere
France Hôpital Purpan (Centre Hospitalier Universitaire Toulouse) Toulouse
Germany Arcus Sportklinik Pforzheim
Italy AO Mauriziano Torino
Netherlands Amphia Ziekenhuis Breda Breda
United Kingdom Wrightington Wigan
United States OrthoCarolina Research Institute Charlotte North Carolina
United States Campbell Clinic Germantown Tennessee
United States Panorama Orthopedics and Spine Center Golden Colorado
United States Rothman Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Australia,  Finland,  France,  Germany,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survivorship Based on removal or intended removal of the device and determined using the Kaplan-Meier method 10 years
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