Study for people with Osteoarthritis
Recruiting Not a phased study
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Sydney Shoulder & Elbow, NSW | Sydney | NSW | Terminated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 9 July 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.