Steroids in Total Knee Arthroplasty

NCT02219581 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00066081
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.

Conditions

Postoperative Pain; Inflammation; Osteoarthritis

Keywords

Osteoarthritis; Postoperative pain; Total knee arthroplasty; Orthopaedics; Inflammation

Outcome Measures

Primary Outcomes (2)

• Pain Score

  Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= "No hurt", to a crying face at 10= "Hurts worst". The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain.

  Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively

• Opioid Analgesic Usage

  The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine.

  1 day post-operatively

Secondary Outcomes (10)

• Soft Tissue Swelling

  1 day post-operatively

• Range of Motion (ROM)

  Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively

• Post-operative Day of Physical Therapy Clearance

  Up to 3 days post-operatively

• Antiemetic Dose Administered

  Post-operative Days 1 and 2

• Blood Glucose

  Baseline, Post-operative Day 1

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of placebo intravenously in addition to a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty. The first dose of placebo will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.

Drug: Standard multimodal pain management regimen; Drug: Placebo

Dexamethasone 10 mg

EXPERIMENTAL

Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 10 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.

Drug: Dexamethasone 10 mg; Drug: Standard multimodal pain management regimen

Dexamethasone 20 mg

EXPERIMENTAL

Subjects undergoing primary total joint arthroplasty of the knee will receive two doses of 20 mg dexamethasone. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting. Additionally, subjects will also receive a standard multimodal postoperative pain management regimen typically used for total knee arthroplasty.

Drug: Dexamethasone 20 mg; Drug: Standard multimodal pain management regimen

Interventions

Dexamethasone 10 mg DRUG

Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.

Also known as: Decadron

Dexamethasone 10 mg

Dexamethasone 20 mg DRUG

Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.

Also known as: Decadron

Dexamethasone 20 mg

Standard multimodal pain management regimen DRUG

The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following: Preoperative: * Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group) Intraoperative: * Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg) * Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. The dose is 15 mg for older patients or if creatinine clearance (CrCl) is low. Postoperative * Tylenol: 1000mg po q 8hr (scheduled) * Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid * IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain * Morphine patient-controlled analgesia (PCA): only for failure of the above * Morphine Sulfate (MS) Contin: Use as backup prn pain

Dexamethasone 10 mg; Dexamethasone 20 mg; Placebo

Placebo DRUG

Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.

Placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary total joint arthroplasty of the knee
• Adult patients ages 18-100 years
• Patients must have smart phone and/or device for app usage

You may not qualify if:

• Current chronic steroid use
• Patients undergoing revision knee surgery
• Patients ambulating preoperatively with assistive devices
• Patients with avascular necrosis of the operative knee
• Patients with a history of an adverse reaction to glucocorticoid steroids
• Patients unable to provide informed consent
• Patients with inflammatory arthritis
• Prisoners
• Current smokers
• Patients \<18 years of age
• Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study.
• Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee.
• Patients with diabetes.
• Patients that have an intolerance to Toradol.
• Patients that do not have smart phone and/or device for app usage

Sponsors & Collaborators

• Thomas L Bradbury: lead

Study Sites (1)

Emory Orthopedic and Spine Hospital

Tucker, Georgia, 30084, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Inflammation; Osteoarthritis

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

There are limitations of the study results due to termination of the study and a small number of study participants.

Results Point of Contact

• Title: Thomas L. Bradbury, MD
• Organization: Emory University

tombradburymd@gmail.com

404-759-3912

Study Officials

• Thomas L Bradbury, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 19, 2014
• Study Start: October 16, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 4, 2022
• Results First Posted: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)