Rheumatoid Arthritis Trial, Recruiting NCT05619588 Sponsor: Exactech Condition: Rheumatoid Arthritis
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Rheumatoid Arthritis Trial, Recruiting

NCT05619588
Recruiting Not Applicable

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 have been recommended for a total ankle replacement surgery
  • People whose bones have finished growing (skeletally mature)
  • People who are mentally able to complete follow-up questionnaires and forms
  • People who are able to attend follow-up appointments for up to 10 years
  • People whom the investigating doctor has assessed as a suitable candidate for ankle replacement
  • People who are willing and able to read and sign a consent form for the study

Who may not be able to join:

  • People with significant bone loss at the ankle joint
  • People with severe osteoporosis (very weak, fragile bones)
  • People with complete loss of blood supply to the talus bone in the ankle (complete talar avascular necrosis)
  • People with an active bone infection (osteomyelitis)
  • People with an infection at the ankle or an infection elsewhere in the body that could spread to the ankle
  • People with sepsis (a serious, body-wide response to infection)
  • People with poor blood circulation in the affected leg
  • People with nerve or muscle problems affecting the ankle, such as prior paralysis or insufficient muscle strength
  • People with damaged joints caused by nerve problems (neuropathic joints)
  • People with a neurological or musculoskeletal condition that may affect movement, walking, or weight-bearing in the lower limb
  • People with insufficient or damaged soft tissue (skin and surrounding tissue) around the ankle
  • People with Charcot arthropathy (a condition causing joint damage related to nerve disease)
  • People who have previously had an ankle fusion surgery that involved removal of the bony prominences around the ankle (malleoli)
  • People whose activity level or body weight places excessive stress on the ankle joint, as determined by the investigating doctor
  • People under 21 years of age at the time of surgery
  • People with dementia
  • People with a known allergy to metal
  • People who are 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: Samuel Adams, MD, Duke Department of Orthopaedic Surgery

Phone: 352-377-1140

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
Exactech
Registry
ClinicalTrials.gov
Start date
4 April 2017
Est. completion
31 December 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

AOFAS; SMFA; SF-36; Sports Frequency Score; VAS Pain and Patient Satisfaction Score

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