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

Pain Clinical Trial

Official title:

Effect of Intravenous Hydrocortisone on Range of Motion After Total Knee Arthroplasty: A Randomized Placebo-Controlled Trial With Nested Case-Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04082533
• Other study ID #: 2018-0660
• Status: Recruiting
• Phase: Phase 4
• Start date: July 24, 2019
• Est. completion date: May 23, 2024

Study information

• Verified date: August 2023
• Source: Hospital for Special Surgery, New York
• Contact: Marla Sharp, MPH, MA
• Phone: (646) 797-8419
• Email: sharpm[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

TKA is the standard of care for treating patients suffering from end-stage knee arthritis and other disabling knee injuries. Indications have increased to ever younger patients and, combined with the aging US population, nearly 700,000 Americans receive TKAs each year. In spite of surgery, many patients experience persistent pain, stiffness or instability that negatively impacts their quality of life; up to 5% experience TKA failure in the first 10 years. Presently, IV stress dose steroids is an accepted practice for bilateral knee replacement (BTKR) leading to decreased pain 24 hours after surgery and improved range of motion (ROM) on postoperative day 2 (POD2). These benefits are likely due to suppression of inflammation immediately after surgery. It is not clear if IV stress dose steroids improve ROM at later time points. Moreover, it is not clear if IV hydrocortisone improves clinical outcomes in unilateral TKA, where pain and joint stiffness remain significant challenges weeks after surgery. The investigators hypothesize that IV hydrocortisone will increase ROM at 6 weeks following surgery. This study will enroll 132 patients that will be followed for up to 2 years. By integrating cell and molecular biology, biomechanics, and imaging technologies (including a CT scan at 1 year), this study is designed to comprehensively examine the long term effects of IV hydrocortisone on joint stiffness, pain, clinically relevant inflammatory states, and the synovium following unilateral TKA. Because subjects with variable ROMs will be enrolled in the study and followed over time, the findings may enable the development of biomarker prediction tools and the targeting of appropriate prevention and management measures for patients at highest risk of joint stiffness and subsequent surgical intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: May 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 83 Years

Eligibility

Inclusion Criteria:

• Elective primary unilateral total knee arthroplasty
• Osteoarthritis (OA) within the affected joint
• Patients of surgeons who have agreed to participate in the study
• Age =18 to 83 years
• American Society of Anesthesiologists (ASA) Physical Status 1-3
• Neuraxial Anesthesia
• Adductor canal block (ACB), Interspace between the popliteal artery and capsule of the posterior knee (IPACK) block (unless valgus knee patient), and Periarticular Injection (PAI) for postoperative pain

Exclusion Criteria:

• Contraindication to regional anesthesia, non-steroidal anti-inflammatory drugs, or steroids
• Pre-operative oral steroid use in the past 3 months
• Body mass index (BMI) greater than or equal to 45
• Intraarticular steroid injections within two months of scheduled surgery in affected joint
• Non-English speaking
• Pre-existing diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
• Active infection
• History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids within one year
• Pregnant women
• Previous study participants in this study
• Type II Diabetes on insulin
• History of refractory postoperative nausea and vomiting (PONV) or PONV after sedation (can include if nausea only after general anesthesia)
• Previous hardware in affected joint
• Open Reduction and Internal Fixation (ORIF) surgery to affected joint
• Cementless total knee arthroplasty (TKA)

Related Conditions & MeSH terms

• Arthrofibrosis
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• Hydrocortisone
Patients will be receiving 100 mg intravenous hydrocortisone every 8 hours, starting in the holding area roughly 2 hours prior to first incision.
• Dextrose 5% in water (D5W)
Patients will be receiving a matched volume of D5W every 8 hours, starting in the holding area roughly 2 hours prior to first incision.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Range of Motion (ROM)	The primary outcome is range of motion at patients' 6 week (±2 weeks) postoperative surgeon appointment.	6 weeks postoperative (±2 weeks)
Secondary	Postoperative Stiffness	The rate of stiffness at the patients' 6 week postoperative surgeon appointment. Stiffness is defined as flexion < 100 degrees or extension lag > 10 degrees.	6 weeks postoperative (±2 weeks)
Secondary	Numeric Rating Scale (NRS)	Patient reported pain level on a scale from 0 (no pain at all) to 10 (worst pain imaginable).	baseline (preoperative), postoperative day (POD) 1, POD2, 6 weeks postop, 1 year postop, 2 years postop
Secondary	PainDETECT Neuropathic Pain Score	Patient reported PainDETECT neuropathic pain scores. Scores from 0-12 indicate no neuropathic pain, 13-18 indicates unclear neuropathic pain, 19-38 indicates positive neuropathic pain. The PainDETECT questionnaire asks numerous questions regarding the type of pain patients are experiencing and answers are scored never (0), hardly noticed (1), slightly (2), moderately (3), strongly (4), and very strongly (5).	baseline (preoperative), 6 weeks postop, 1 year postop, 2 years postop
Secondary	Opioid consumption	Patient reported opioid consumption information at pre-surgical screening appointment, in the holding area before surgery, on postoperative day 1, postoperative day 2, 6 weeks, 6 months, 1 year and 2 years postoperatively	pre-surgical screening (PSS and holding area), day of surgery (DOS), POD1, POD2 at 6 weeks, 6 months 1 year and 2 years postoperatively,
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS Jr.)	Knee injury and Osteoarthritis Outcome Score (KOOS Jr.) scores measured at baseline, 6 weeks, 6 months and 1 year and 2 years postoperatively. The KOOS Jr. survey involves 7 questions scored from 0 to 4 for a total score of 0 to 28. A score of 0 correlates to complete loss of knee function, whereas 28 correlates to completely healthy knee function.	Preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative
Secondary	Lower extremity Activity Survey (LEAS) scores	Lower extremity Activity Survey (LEAS) scores at baseline, 6 weeks, 6 months and 1 year and 2 years postoperatively. The LEAS contains 20 questions regarding a person's ability to perform everyday function. Each question is scored from 0-4. A score of 0 correlates to no function and complete inability to perform every day tasks to 80 correlating to normal function.	preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative
Secondary	Veterans Rand 12-item health survey (VR-12) score	The Veterans Rand 12-item health survey (VR-12) scores at baseline, 6 weeks, 6 months and 1 year and 2 years postoperatively. The VR-12 questionnaire is a series of 12 questions that evaluate a patient's physical and emotional health status. It is scored from 0 to 50, with 50 correlating to healthy mental and physical status.	preoperative, 6 weeks, 6 months, 1 year, 2 years postoperative
Secondary	TIme to physical therapy goals completion	Time to attainment of physical therapy (PT) goals (Ambulation 100 meters, independent transfer) measured during inpatient stay.	postoperative day 0-3
Secondary	Inflammatory state (via protein, ribonucleic acid (RNA), cellular, and tissue level analyses	Day of surgery (pre-operative), POD 1 , and postoperative week 6 (±2 weeks) inflammatory state (via protein, ribonucleic acid (RNA), cellular, and tissue level analyses)	Day of surgery (preoperative), postoperative day 1, postoperative week 6 (±2 weeks)
Secondary	MRI Findings	MRI Findings (pre-operative, 1 yr, 2yr ). MRIs of the knee will be reviewed by the radiology department and their findings and changes noted and logged.	preoperative, 1 year, 2 years
Secondary	Biomechanical findings	Biomechanical findings as assessed by EOS® imaging (pre-op, 6 weeks, 1 year)	preoperative, 6 weeks, 1 year