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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02469662




Registration number
NCT02469662
Ethics application status
Date submitted
8/06/2015
Date registered
11/06/2015
Date last updated
7/08/2020

Titles & IDs
Public title
Clinical Outcomes Study of the Nexel Total Elbow
Scientific title
Retrospective and Prospective Clinical Outcomes Study of the Zimmer® Nexelâ„¢ Total Elbow
Secondary ID [1] 0 0
CMU2014-06E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elbow Joint Destruction 0 0
Post-traumatic Lesions 0 0
Ankylosed Joints 0 0
Advanced Rheumatoid Arthritis 0 0
Joint Instability or Loss of Motion 0 0
Acute Comminuted Articular Fracture of Elbow Joint Surfaces 0 0
Bone Loss Contributing to Elbow Instability 0 0
Bilateral Ankylosis From Causes Other Than Active Sepsis 0 0
Post-traumatic Arthritis 0 0
Degenerative Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Nexel Total Elbow

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


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survivorship - Based on removal or intended removal of the device and determined using the Kaplan-Meier method
Timepoint [1] 0 0
10 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Shoulder & Elbow, NSW - Sydney
Recruitment postcode(s) [1] 0 0
2067 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Finland
State/province [5] 0 0
Tampere
Country [6] 0 0
France
State/province [6] 0 0
Toulouse
Country [7] 0 0
Germany
State/province [7] 0 0
Pforzheim
Country [8] 0 0
Italy
State/province [8] 0 0
Modena
Country [9] 0 0
Netherlands
State/province [9] 0 0
Breda
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02469662
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Erin Osborn
Address 0 0
Zimmer Biomet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Madison Thompson
Address 0 0
Country 0 0
Phone 0 0
574-373-2265
Fax 0 0
Email 0 0
madison.thompson@zimmerbiomet.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02469662