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Trial record 3 of 620 for:    orthopedic

Post-operative Methylprednisolone Taper Course for Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT03661645
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Gottschalk, Emory University

Brief Summary:

The clinical trial is a prospective randomized control trial of a group of patients undergoing surgical management of common orthopedic pathologies including fractures of the upper extremity and shoulder arthroplasty; patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.

Patients will be assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group, IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (Active Group).

The purpose of this study is to study the efficacy of a post-operative course of glucocorticoids (GCs like Methylprednisolone) on pain, nausea and range of motion after surgical management of common orthopedic upper extremity pathologies, including fractures of the upper extremity and shoulder arthroplasty and patients undergoing total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee.


Condition or disease Intervention/treatment Phase
Orthopedic Surgeries Drug: 10 mg IV dexamethasone & 6 day oral methylprednisolone taper Other: 10 mg IV dexamethasone Phase 4

Detailed Description:

Reducing pain and improving function is of great importance in the immediate period after surgery. Many orthopaedic procedures result in fluid build-up around the surgical site which results in pain and decreased healing. Glucocorticoids are drugs that block the inflammatory process which can decrease this pain and fluid build-up. Furthermore, glucocorticoids are safe if given in low doses and for a short period of time. To help address this gap, the study intend to give patients glucocorticoids after various upper extremity orthopedic procedures; total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee, assessing their pain and range of motion post-operatively. The study hypothesize that glucocorticoids will result in less inflammation around the surgical site, leading to pain relief, greater healing ability, and improvements in range of motion of the injured joint.

The study aims to enroll 1000 subjects that are assigned randomly to one of two treatment arms: (1) single intraoperative dose of 10 mg intravenous dexamethasone (control group), IV dexamethasone is standard of care) or (2) single intraoperative dose of 10 mg intravenous dexamethasone followed with a 6-day oral methylprednisolone taper course (active group). Subjects will be followed up in clinic 2, 6, and 12 weeks postoperatively that is a standard of care for upper extremity fractures, shoulder arthroplasty, total hip arthroplasty for osteoarthritis of the hip or total knee arthroplasty for osteoarthritis of the knee


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized Controlled study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-operative Methylprednisolone Taper Course for Orthopedic Surgery
Actual Study Start Date : September 7, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Active Comparator: Methylprednisolone Treated Group
Subjects in this group will receive single intraoperative course of 10 mg IV dexamethasone & 6 day oral methylprednisolone taper that is 10 mg Intravenous IV dexamethasone and 6 day oral methylprednisolone taper course
Drug: 10 mg IV dexamethasone & 6 day oral methylprednisolone taper

Drug: 6-day oral methylprednisolone (glucocorticoid) taper course The oral methylprednisolone taper course will begin on the day of surgery and will include 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day.

Drug:10 mg intravenous (IV) dexamethasone

Other Names:
  • Medrol, Depo-Medrol, Solu-Medrol, A-Methapred
  • Decadron, Dexasone, Diodex, Hexadrol, Maxidex

Control Group
Subjects in this group will receive single intraoperative dose of 10 mg IV dexamethasone; that is 10 mg Intravenous (IV) dexamethasone
Other: 10 mg IV dexamethasone
Drug:10 mg intravenous (IV) dexamethasone
Other Name: Decadron, Dexasone, Diodex, Hexadrol, Maxidex




Primary Outcome Measures :
  1. Change in post-operative pain scores using numeric verbal analogue scores (VAS-Pain) during follow up in the methylprednisolone treated group compared to the control group [ Time Frame: Post Operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    Pain assessment will be assessed before performing the injection, at the time of injection, and at each subsequent follow up visit using the Visual Analog Pain Scale (VAS-pain). The pain VAS is self‐completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance (mm) on the 10‐cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. Pain will be assessed at rest and active movement of the affected joint. Cut points for VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Normative values are not available.

  2. Change in post-operative nausea scores using numeric verbal analogue scores (VAS-Nausea) during follow up in the methylprednisolone treated group compared to the control group [ Time Frame: Post Operative day (1-7), 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    The (VAS-Nausea) questionnaire is self‐completed by the subject. Subject is asked to place a line perpendicular to the VAS line at the point that represents their nausea severity.Subjects will rate their nausea severity on a 10-cm visual analog scale. The scale is ranked from 0 (least severe) to 10 (most severe).

  3. Change in Range of Motion (ROM) prior to surgery and during follow up in the methylprednisolone treated group compared to the control group [ Time Frame: Pre operatively, 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    ROM assessment will take place at each clinic follow up with a hand-held goniometer. . This will be done by assessing the total flexion-extension arc of the wrist, elbow, shoulder, knee, or hip; the total pronation-supination arc at the wrist; and the adduction-abduction arc of the wrist, shoulder, and hip. ROM will be assessed on the contralateral side prior to surgery.


Secondary Outcome Measures :
  1. Change in post operative Patient-Rated Wrist Evaluation (PRWE) scores during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0.Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100).

  2. Change in postoperative American Shoulder and Elbow Surgeons Shoulder Score (ASES) during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability).

  3. Change in Short Form Health Survey (SF-12) scores during follow up in the methylprednisolone treated group compared to the control group [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.

  4. Change in postoperative Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) scores during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.

  5. Change in postoperative handgrip strength during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for upper extremity injuries [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    Handgrip strength and handgrip endurance will be assessed using a digital hand dynamometer. After verbal instruction, subjects will perform 5 maximal handgrips - separated by 30 second pauses - with their injured hand. This test will be administered in a seated position with the upper arm vertically aligned and slightly abducted to avoid upper body contact. The highest value will be used of the 5 maximal hand grips will be used to express handgrip strength in newtons (N). The patient will also perform an endurance handgrip where a subject is told to hold for as long as possible, and time will be recorded (in seconds) for the force to decrease by 50% of starting force.

  6. Change in postoperative KOOS during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for for knee injury or posttraumatic osteoarthritis (OA) injuries [ Time Frame: Pre operatively, 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    Knee injury and Osteoarthritis Outcome Score (KOOS) consists of 5 subscales; Pain, other Symptoms, Activities of Daily Living (ADL), Sport and Recreation Function (Sport/Rec) and knee-related Quality of Life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  7. Change in postoperative HHS during follow up in the methylprednisolone treated group compared to the control group among subjects that underwent surgical management for total hip arthroplasty [ Time Frame: 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    The Harris Hip Score (HHS) was developed for the assessment of the results of hip surgery, and to evaluate various hip disabilities and methods of treatment.The function domain consists of daily activities (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.There are 10 items. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0 - 44 points), function (7 items, 0 - 47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70 - 80 is considered fair, 80 -90 is good, and 90 -100 is an excellent result. No normative values are available

  8. Change in subject's pain control and satisfaction with the procedure and whether it meets or exceeds their expectations in the methylprednisolone treated group compared to the control group [ Time Frame: Pre operatively, 2 weeks, 6 weeks, and 12 weeks postoperatively ]
    Patients will be asked about their pain control and satisfaction with the procedure and whether it meets or exceeds their expectations The questionnaire is study specific that is intended to measure change in pain and patients satisfaction from baseline to after the procedure. The questionnaire is numeric questionnaire and does not have sub scales or sub scores. The scale is rated for Pain as a range from 1-10, with 10 being the worst possible pain and for patient satisfaction 1-10, 10 being most satisfied. These scores will also be assessed pre-operatively and 2 weeks, 6 weeks, and 12 weeks postoperatively. The preoperative scores will be compared to the postoperative scores at 2 weeks, 6 weeks, and 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of Emory Hand Surgeons undergoing surgery for an upper extremity fracture who are willing to participate in the study will be included in the study (Including American Orthopedic(AO) and American Orthopaedic Trauma Association (OTA) AO/OTA Classification 1, 2, and 7 +/- Type A, B, C).
  • Patients of Emory Hand Surgeons undergoing Total Shoulder Arthroplasty or Reverse Shoulder Arthroplasty who are willing to participate in the study will be included in the study (Walsh Classification A-D).
  • Patients undergoing total hip arthroplasty for osteoarthritis of the hip
  • Patients undergoing total knee arthroplasty for osteoarthritis of the knee
  • Between the ages of 18 years and 95 years.
  • Patients willing and able to provide written and informed consent

Exclusion Criteria:

  • Patients with concurrent and significant injuries to other bones or organs.
  • Patients with local infections.
  • Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study.
  • History of alcohol or medical abuse, allergies to glucocorticoids, daily use of glucocorticoids or chronic opioid use prior to the injury (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nico morphine, oxycodone, and meperidine), history of severe heart disease ( New York Heart Association (NYHA 2)), renal failure, or liver dysfunction, active peptic ulcer disease, diabetic neuropathy, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception.
  • Women who are pregnant
  • Patients with pre-existing immune suppression, where further immune suppression with GCs could warrant unwarranted or unneeded risk.
  • Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661645


Contacts
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Contact: Michael Gottschalk, MD 404-727-5658 michael.gottschalk@emoryhealthcare.org
Contact: Kevin Farley, MD 404-727-5658 kevin.xavier.farley@emory.edu

Locations
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United States, Georgia
Emory Clinic A, Clifton Road Clinic Recruiting
Atlanta, Georgia, United States, 30322
Contact: Michael Gottschalk, MD    404-727-5658    michael.gottschalk@emoryhealthcare.org   
Principal Investigator: Michael Gottschalk, MD         
12 Executive Park Drive Recruiting
Atlanta, Georgia, United States, 30329
Contact: Michael Gottschalk, MD    404-727-5658    michael.gottschalk@emoryhealthcare.org   
Principal Investigator: Michael Gottschalk, MD         
Emory Healthcare Orthopaedics and Spine Center Recruiting
Atlanta, Georgia, United States, 30329
Contact: Michael Gottschalk, MD    404-727-5658    michael.gottschalk@emoryhealthcare.org   
Principal Investigator: Michael Gottschalk, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Michael Gottschalk, MD Emory University

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Responsible Party: Michael Gottschalk, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03661645     History of Changes
Other Study ID Numbers: IRB00104310
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Michael Gottschalk, Emory University:
Glucocorticoids(GS)
injection

Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Glucocorticoids
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents