Phase 4 Osteoarthritis Trial, Recruiting NCT06083480 Sponsor: Vanderbilt University Medical Center Condition: Osteoarthritis
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Phase 4 Osteoarthritis Trial, Recruiting

NCT06083480
Recruiting Phase 4

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 aged 50 or older
  • People whose thinking and memory are assessed as sufficiently intact to understand and agree to take part in the study (checked using a standard mental status screening test)
  • People who can read and write in English well enough to understand and complete study questionnaires
  • People who are scheduled to have a single knee replacement surgery for the first time (on one knee only)
  • People who have been medically diagnosed with osteoarthritis
  • People who have reported their worst pain in the past 24 hours as at least 4 out of 10 on a pain rating scale

Who may not be able to join:

  • People who have a diagnosed pre-existing nerve disorder (neuropathy)
  • People who have an untreated thyroid condition (either underactive or overactive thyroid)
  • People who have untreated heart disease
  • People whose liver function blood test results are more than twice the upper limit of the normal range (confirm with trial site)
  • People whose kidney function blood test results show a creatinine level above 1.5 mg/dl (confirm with trial site)
  • People who are pregnant
  • People who have been diagnosed with Complex Regional Pain Syndrome (a chronic pain condition) before their knee replacement surgery
  • People who have vascular disease, inflammatory conditions, autoimmune disorders, or cancer affecting the legs
  • People who have significant ongoing pain in parts of the body other than the lower limbs — specifically, daily pain lasting more than 3 months that is rated 3 out of 10 or higher in intensity, or that is already the focus of medical care
  • People whose overall health situation is considered by the orthopaedic surgeon leading the study to make participation in the trial unsafe

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 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Stephen Bruehl, Ph.D., Vanderbilt University Medical Center

Phone: (615) 936-1821

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
Phase 4
Registry
ClinicalTrials.gov
Start date
6 December 2024
Est. completion
1 September 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hours

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: 23 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