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Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later May 2026 → Jul 2027
Enrollment reduced 51% 132 → 65 participants
See other at-risk trials from Hospital for Special Surgery, New York

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 6 of 11 entries
  2. Primary and study completion pushed from May 2026 to Jul 2027
    • Enrollment reduced: 132 → 65 participants
    v14
  3. Re-verified, no change to tracked fieldsv13
  4. Primary and study completion dates: May 23, 2025 to May 2026v12
  5. Primary and study completion dates: May 23, 2024 to May 23, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary and study completion dates: May 23, 2023 to May 23, 2024v10
  2. Primary completion date: Jun 21, 2022 to May 23, 2023
    • Study completion date: Jan 1, 2023 to May 23, 2023
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Jul 1, 2021 to Jun 21, 2022v7
  5. 2 versions Re-verified since Aug 18, 2020, no change to tracked fieldsv5-v6
  6. Secondary endpoints: details revised at 1 of 11 entries
    • Study description expanded, about 7 words
    v4
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 23, 2019 to Jul 24, 2019
    • Site details revised
    v3
  8. Start date: Sep 1, 2019 to Sep 23, 2019
    • Interventions: Hydrocortisone (Drug), Saline (Drug) to Dextrose 5% in water (D5W) (Drug), Hydrocortisone (Drug)
    • Site contact updated
    • Eligibility criteria expanded, about 3 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this study, total knee replacement patients will be determined to be stiff or non-stiff preoperatively. Stiffness designation is determined by preoperative range of motion (if flexion is \< 100 degrees, or extension lag is \> 10 degrees). The stiff and non-stiff groups will both be randomized to two groups to receive either intravenous hydrocortisone or a placebo at 3 intervals postoperatively. Patients will be followed up with in hospital and via the phone on postoperative day (POD) 1 and 2, as well as 6 weeks, 6 months, 1 year, and 2 years postoperatively. Patients will also have blood drawn preoperatively in the OR, on POD1, at their 6 week followup, and at their 1 and 2 year follow ups. This blood will be processed and analyzed.
Trial Details
NCT Number NCT04082533
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Pain, Arthrofibrosis, Osteoarthritis, Knee
Related terms Osteoarthritis, Knee, Pain
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov