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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Patient has a currently active or history of repeated local infection at the surgical

- 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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
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
Country [4] 0 0
United States of America
State/province [4] 0 0
Country [5] 0 0
State/province [5] 0 0
Country [6] 0 0
State/province [6] 0 0
Country [7] 0 0
State/province [7] 0 0
Country [8] 0 0
State/province [8] 0 0
Country [9] 0 0
State/province [9] 0 0
Country [10] 0 0
United Kingdom
State/province [10] 0 0

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

Ethics approval
Ethics application status

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
Trial related presentations / publications
Public notes

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
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see