Clinical trial NCT03661645: Post-operative Methylprednisolone Taper Course for Orthopedic Surgery
Official title: Post-operative Methylprednisolone Taper Course for Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Orthopedic Surgeries
Keywords: Glucocorticoids(GS)
injection
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized Controlled study
Primary purpose: TREATMENT

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; arthritis surgeries (ex. carpometacarpal arthroplasty), release of compressive neuropathies (ex. carpal tunnel surgery), tendon procedures (ex. tendon repair), 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.

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 500 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

Eligibility 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 of Emory Hand Surgeons undergoing surgery for upper extremity arthritis (ex. carpometacarpal arthroplasty)
* Patients of Emory Hand Surgeons undergoing release for upper extremity compressive neuropathies (ex. carpal tunnel surgery)
* Patients of Emory Hand Surgeons undergoing procedures for upper extremity tendon pathologies (ex. tendon repair)
* 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.

Primary outcomes:
measure: 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
timeFrame: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
measure: 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
timeFrame: Post Operative day (1-15), 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
measure: Change in Range of Motion (ROM) prior to surgery and during follow up in the methylprednisolone treated group compared to the control group
timeFrame: Pre operatively, 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
measure: 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
timeFrame: 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
measure: 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
timeFrame: 2 weeks, 6 weeks, 12 weeks, and 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic A, Clifton Road Clinic
state: Georgia
city: Atlanta
country: United States
facility: 21 Ortho Lane
state: Georgia
city: Atlanta
country: United States
facility: Emory Healthcare Orthopaedics and Spine Center
state: Georgia
Study officials:
affiliation: Emory University
name: Michael Gottschalk, MD
role: PRINCIPAL_INVESTIGATOR
References: