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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04082533
The ClinicalTrials.gov registry entry for NCT04082533 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (57% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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