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NCT04082533 · ClinicalTrials.gov registry record · Phase 4
Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)
A Phase 4 study of Pain and Osteoarthritis, Knee, sponsored by Hospital for Special Surgery, New York.
- Active
- Registry status
- Phase 4
- Development phase
- 132
- Enrollment target
- 1
- Study location
NCT04082533: Active Phase 4 study of Pain and Osteoarthritis, Knee, sponsored by Hospital for Special Surgery, New York.
NCT04082533 is a Phase 4 study of Pain and Osteoarthritis, Knee that is active but no longer recruiting, run by Hospital for Special Surgery, New York. The registered enrollment target is 132 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04082533, a Phase 4 study of Pain and Osteoarthritis, Knee, is active but no longer recruiting, sponsored by Hospital for Special Surgery, New York.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 132 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The primary outcome is range of motion at patients' 6 week (±2 weeks) postoperative surgeon appointment.
Conditions Studied
Interventions
- DRUG Hydrocortisone
- DRUG Dextrose 5% in water (D5W)
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2019-07-24 |
| Est. Completion | 2026-05 |
| Phase | Phase 4 |
What the registry record for NCT04082533 still lists
NCT04082533 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (57% lower).
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Hydrocortisone is the first listed.
NCT04082533 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04082533 about?
NCT04082533 is a clinical study titled "Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)". 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 ...
What is the current status of trial NCT04082533?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 132 participants. The study started on 2019-07-24. Estimated completion is 2026-05.
What conditions does trial NCT04082533 study?
This clinical trial studies the following conditions: Pain, Osteoarthritis, Knee, Arthrofibrosis.
What interventions are being tested in trial NCT04082533?
The interventions under investigation include: Hydrocortisone (DRUG), Dextrose 5% in water (D5W) (DRUG).
Who is sponsoring clinical trial NCT04082533?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04082533 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04082533's enrollment target sits among peer trials
132 125th of 374 higher than 249 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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