IV Hydrocortisone for Post-Knee Replacement Recovery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Hospital for Special Surgery, New York

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults aged 18 to 83 undergoing elective knee replacement surgery without a history of certain joint treatments or conditions like rheumatic diseases. Participants must not have had steroid injections recently, be on long-term opioids, or have a BMI over 45. They should be able to communicate in English and not have an active infection.

Inclusion Criteria

I am receiving specific nerve blocks and injections for post-surgery pain.

I have osteoarthritis in my joint.

I am scheduled for a knee replacement surgery on one knee.

See 4 more

Exclusion Criteria

Pregnant women

Previous study participants in this study

You have had previous implants or devices placed in the joint being studied.

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Treatment Details

Interventions

Hydrocortisone (Corticosteroid)

Trial OverviewThe study tests if IV hydrocortisone can improve outcomes after knee replacement surgery. Patients are grouped by pre-surgery stiffness and then randomly get either hydrocortisone or placebo postoperatively. Follow-ups occur from the day after surgery up to two years, with blood tests at key intervals.

Participant Groups

4Treatment groups

Active Control

Placebo Group

Group I: Non-stiff Intravenous HydrocortisoneActive Control1 Intervention

Total knee replacement patients without preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of 100mg intravenous hydrocortisone every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.

Group II: Stiffness Intravenous HydrocortisoneActive Control1 Intervention

Total knee replacement patients with preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of 100mg intravenous hydrocortisone every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.

Group III: Non-stiff Intravenous placeboPlacebo Group1 Intervention

Total knee replacement patients without preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of matched volume diluent every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.

Group IV: Stiffness Intravenous PlaceboPlacebo Group1 Intervention

Total knee replacement patients with preoperative knee stiffness (defined as flexion \< 100 degrees or extension lag \> 10 degrees) receive 3 doses of matched volume diluent every 8 hours. The first dose is given in the holding area approximately 2 hours prior to first incision.