Treatment for Total Knee Arthroplasty (TKA)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Columbia University Irving Medical Center, New York, NY
Total Knee Arthroplasty (TKA)
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a dose of dexamethasone can reduce postoperative opioid consumption and pain, improve postoperative nausea and vomiting, and minimize postoperative complications.

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Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 6 secondary outcomes in patients with Total Knee Arthroplasty (TKA). Measurement will happen over the course of Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale..

48-hours postoperative (after surgical intervention)
Opioid consumption
Day 30
Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention
Day 1
Postoperative pain scores at rest and with activity
Day 1
Sleeplessness/insomnia
Day 1
Postoperative nausea and vomiting
Day 30
Postoperative Blood glucose levels and insulin use
Day 30
Length of stay

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

3 Treatment Groups

Group 2
1 of 3
Group 1
1 of 3
Group 3
1 of 3
Active Control

This trial requires 429 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Group 2
Drug
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Group 1
Drug
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Group 3
Drug
16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery for reporting.

Who is running the study

Principal Investigator
C. J. D. V.
Prof. Craig J Della Valle, MD
Rush University Medical Center

Closest Location

Columbia University Irving Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I am over 18 years old. show original
Primary total knee arthroplasty
are twice as likely to get an infection as those going home the same day show original

Patient Q&A Section

Have there been other clinical trials involving treatment?

"The most common therapy in randomized clinical trials is surgery with or without a biological or mechanical prosthesis. It seems unlikely that a biological or mechanical prosthesis will replace whole joint arthroplasty." - Anonymous Online Contributor

Unverified Answer

Can total knee arthroplasty (tka) be cured?

"Total knee arthroplasty does not invariably restore knee function to that of the unaffected limb. Although patient satisfaction is acceptable, surgeons and the broader orthopaedic community must consider other factors including the physical limitations and functional outcome of a limb, which may not be improved on TKA." - Anonymous Online Contributor

Unverified Answer

What causes total knee arthroplasty (tka)?

"There was a wide range in the reasons for tka, but many reasons did not appear to be related to patient age, gender, ethnicity, or type of tka used." - Anonymous Online Contributor

Unverified Answer

How many people get total knee arthroplasty (tka) a year in the United States?

"For total knee and hip replacement procedures, the rates of tka are rising dramatically. The use of patient and insurance characteristics in the determination of these changes likely plays a significant role in the increase in tka. Further studies are needed to determine whether the increase in the use of tka in the United States is being due to better surgical technique, or to increased indications for tka for people who would benefit from it." - Anonymous Online Contributor

Unverified Answer

What is total knee arthroplasty (tka)?

"TKA is a common operation that can be done to rehabilitate patients with knee osteoarthritis. TKA is now an important and rewarding procedure in which the results can not only last a lifetime, but be durable and functional. TKA is a safe and versatile operation that can be performed on patients of all ages. TKA would be a safe and effective measure to alleviate pain and disability in millions of people every year." - Anonymous Online Contributor

Unverified Answer

What are the signs of total knee arthroplasty (tka)?

"tka is a highly effective surgical treatment with a success rate of 80-90%. Many patients have post-operative deficits because of their age, illness or concomitant injuries. Some patients also have tka after an injury.\nCurrently most clinical signs of TKA are based on the American Orthopaedic Association's (AO) Joint Committee on Standards of Clinical Radiology's (COJOS) Criteria. These criteria are defined as the five following signs:\n\n- a. Any pain in the area of the knee or swelling above and below the knee\n- b. A lump in the same area\n- c." - Anonymous Online Contributor

Unverified Answer

What are common treatments for total knee arthroplasty (tka)?

"TKA can be effectively and effectively performed, resulting in excellent subjective function and a stable revision rate of 11%. Patient age and gender are independent factors that may influence outcome following a revision TKA." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for total knee arthroplasty (tka)?

"Patients with lower activity levels (e.g. those in a wheelchair who have an activity limitation), those who were younger, white, and female may be candidates for clinical trials to prevent TKA recurrence or revision. Given the limitations in the data analyzed, prospective trials are needed to provide more information on which patients should or should not participate in a clinical trial of TKA." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"The current study corroborates the notion that combined meniscal and cartilage surgery is an effective treatment for most patients with OA, but the results did not reach statistical significance." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of total knee arthroplasty (tka)?

"The primary causes of TKA are pain, deformity (such as malalignment or subluxation), and poor function. Deformity and malalignment occur in about one-third to one-half of patients. The primary causes of pain are instability of the knee, and most common causes of pain are osteoarthritis, osteoarthritis of the patella, bicompartmental cartilage damage, patellar resurfacing, and acute or chronic chondritis. Degenerative changes are the most common cause of bone loss in the knee." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"The majority of patients treated for tKA were discharged home. We found few patients were discharged to rehabilitation or long-term inpatient care. This result suggested patients may not follow the expected course of treatment after tKA. Other findings include differences in patients' baseline knee function, which can be used by clinicians to counsel patients about expected outcomes and care plans for the period after tKA." - Anonymous Online Contributor

Unverified Answer

How serious can total knee arthroplasty (tka) be?

"Total knee arthroplasty can be lifesaving and durable. Most patients can expect to live 20 years or more. TKA has significant short-term complications and requires significant blood loss. Arthroscopic surgery can address a multitude of other knee problems. To minimize the risk of complications or increase the time to resolution, a multidisciplinary approach is important." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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