Rheumatoid Arthritis Trial, Recruiting NCT02469662 Sponsor: Zimmer Biomet Condition: Rheumatoid Arthritis
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Rheumatoid Arthritis Trial, Recruiting

NCT02469662
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older.
  • People who have signed a consent form that has been approved by an ethics review board.
  • People who have been identified as a candidate for a first-time or repeat total elbow replacement surgery, due to at least one of the following conditions:
    • Severe elbow joint damage that significantly affects everyday activities.
    • Injury-related damage or bone loss that makes the elbow unstable.
    • A stiff, locked elbow joint (especially when both elbows are affected, for reasons other than active infection).
    • Advanced arthritis (rheumatoid, injury-related, or wear-and-tear) causing severe, disabling pain.
    • Elbow instability or limited movement where the damage to the joint or surrounding tissue is too extensive for standard bone repair.
    • A severe, complex fracture of the elbow joint that cannot be treated with less invasive procedures, including certain fractures of the lower end of the upper arm bone.
  • People who are willing and able to attend follow-up appointments as required by the study.
  • (For a separate, retrospective part of the study only) People who had a total elbow replacement using the Nexel system between July 2013 and the date the study site began, and whose medical records include pre-surgery details, a physical exam record, the surgical report, and details of the devices used.

Who may not be able to join:

  • People who currently have, or have had repeated, infections at or near the surgery site.
  • People who currently have a serious infection elsewhere in the body.
  • People who have a history of a severe, widespread infection (sepsis).
  • People who have paralysis or significant nerve problems affecting the elbow joint.
  • People who have significant problems with the function of the hand on the same side as the affected elbow.
  • People who have heavy scarring near the surgery site that could prevent proper healing of the surrounding tissue.
  • People whose daily activities place heavy stress on a joint implant, such as heavy physical labour, high twisting forces on the arm, or competitive sports.
  • People who are currently imprisoned.
  • People who are not able to understand what taking part in the study involves.
  • People who have a known problem with alcohol or drug misuse.
  • People who are not expected to be able to follow the study requirements.
  • People who are known to be pregnant.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Hillary Overholser, MS, Zimmer Biomet

Phone: 574-453-7567

Australian sites

Sydney Shoulder & Elbow, NSW, Sydney, New South Wales

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Zimmer Biomet
Registry
ClinicalTrials.gov
Start date
1 June 2015
Est. completion
1 December 2035

Where this trial is recruiting

🇦🇺 Australia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇳🇱 Netherlands 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Survivorship

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov