Losartan for Total Knee Replacement Complications
Recruiting in Palo Alto (17 mi)
Overseen ByScott Tashman, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Steadman Philippon Research Institute
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.
Is the drug Losartan a promising treatment for complications after total knee replacement?The provided research articles do not mention Losartan as a treatment for complications after total knee replacement, so there is no information to suggest it is promising for this purpose.1491113
What safety data is available for Losartan in knee replacement complications?The provided research does not contain specific safety data for Losartan, Cozaar, or Hyzaar in the context of total knee replacement complications. The studies focus on general adverse events and complications related to total knee arthroplasty, but do not mention Losartan or its equivalents.125814
What data supports the idea that Losartan for Total Knee Replacement Complications is an effective drug?The available research does not provide specific data on Losartan's effectiveness for Total Knee Replacement Complications. The studies focus on identifying risk factors for complications, outcomes after knee arthroplasty in specific populations, and other related topics, but do not mention Losartan as a treatment for these complications. Therefore, there is no direct evidence from the provided information to support the idea that Losartan is effective for this purpose.3671012
Do I need to stop taking my current medications to join the trial?You must stop taking Losartan, medications in the same drug class, Warfarin, related anticoagulants, and opioid analgesics (unless prescribed post-surgery). If you're on any medication that interacts with Losartan, you may also need to stop. The protocol doesn't specify other medications, so check with the study team.
Eligibility Criteria
This trial is for adults over 18 who are planning to have a knee replacement surgery on one knee and can consent to the study. They should not be hypotensive, pregnant, or planning pregnancy; nor should they have had previous knee replacements or surgeries planned during the study. They must not take opioids recently or certain medications like Losartan.Inclusion Criteria
I can make my own medical decisions and agree to follow the study's requirements.
I am 18 years old or older.
I am scheduled for a total knee replacement on one knee.
Exclusion Criteria
My knee arthritis is due to an autoimmune disease.
I am not planning any leg surgery other than knee replacement in the study leg.
I do not have any conditions besides knee osteoarthritis that affect my walking or daily activities.
I have taken opioid painkillers in the last 8 weeks and am not willing to stop during the study.
I am taking medication that interacts badly with Losartan.
I have had knee replacement surgery on the knee being studied.
I am planning to have knee replacement surgery on my other knee during the study.
I am currently taking Losartan or similar blood pressure medication, and Warfarin or a similar blood thinner.
Participant Groups
The trial is testing if taking Losartan before and after knee replacement surgery can prevent arthrofibrosis (stiffness) and improve outcomes. Participants will either receive Losartan or a placebo without knowing which one they're getting.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Losartan (investigational)Experimental Treatment1 Intervention
Losartan 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).
Group II: Placebo (control)Placebo Group1 Intervention
Losartan Placebo 12.5 mg, PO, BID, for four weeks post-TKA surgery (on Days 1 through 28, starting the day after surgery).
Losartan is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cozaar for:
- Hypertension
- Diabetic nephropathy
- Stroke prevention in hypertension and left ventricular hypertrophy
🇪🇺 Approved in European Union as Cozaar for:
- Hypertension
- Diabetic nephropathy
- Heart failure
🇨🇦 Approved in Canada as Cozaar for:
- Hypertension
- Diabetic nephropathy
- Heart failure
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
The Steadman ClinicVail, CO
Loading ...
Who is running the clinical trial?
Steadman Philippon Research InstituteLead Sponsor
References
Complications of total knee replacement. [2016]The records and radiographs of 162 patients with 224 total knee replacements were reviewed for evidence of complications. Early complications included cardiovascular abnormalities, in particular deep vein thrombosis (3%), and limitation of motion requiring manipulation under anesthesia (7%). Late problems included patellofemoral arthritis (11%), heterotopic bone formation (10%), loosening (7%), deformity (4%), fracture (3%), and infection (2%). Patellofemoral pain and arthritis is the most common and often the most disabling complication.
Adverse events after total knee arthroplasty: a national Medicare study. [2009]Adverse events from 2033 total knee arthroplasty patients were documented by nonphysician abstractors. The annual rate of adverse events from 2002 to 2004 was 9.2%, 6.4%, and 5.8%, respectively. Congestive heart failure (odds ratio, 2.1; 95% confidence interval, 1.2-3.5; P
Long-term Results of Hybrid Total Knee Arthroplasty: Minimum 10-years Follow-up. [2021]To evaluate the survival rate and long term clinical outcomes of hybrid total knee arthroplasty (TKA).
Acute kidney injury in the setting of knee arthroplasty: a case report and discussion investigating Angiotensin-converting enzyme inhibitors as the culprit. [2021]Total knee arthroplasty (TKA) has become the predominant treatment modality for severe degenerative joint disease. With recent advancements in surgical and anesthetic technique, patients with severe comorbidities are able to have this procedure; they would have been precluded from TKA only a matter of years ago. Although many studies have investigated risk factors and the causes of perioperative morbidity and mortality in the arthroplasty patient, few have linked risk factors with specific outcomes. We present a case report that illustrates the link between the use of angiotensin-converting enzyme inhibitors and the development of postoperative acute kidney injury. While this relationship has been extensively studied in cardiac and gastric bypass patient populations, it has never been examined in the setting of joint replacement.
Rheumatoid Arthritis Does Not Increase Risk of Short-term Adverse Events after Total Knee Arthroplasty: A Retrospective Case-control Study. [2022]More adverse events (AE) are reported after total knee arthroplasty (TKA) for patients with rheumatoid arthritis (RA) than for patients with osteoarthritis (OA). This study evaluates 6-month postoperative AE in a high-volume center in a contemporary RA cohort.
How Do Previous Solid Organ Transplant Recipients Fare After Primary Total Knee Arthroplasty? [2018]Total knee arthroplasty (TKA) has been proven to increase knee outcome scores after solid organ transplantation (SOT), but many authors are concerned about a higher complication rate. The purpose of this study is to evaluate the complication profile of TKA after previous SOT.
Identification of high-risk groups for complication after arthroplasty: predictive value of patient's related risk factors. [2020]Total joint arthroplasty (TJA) benefit patients with osteoarthritis (OA) and rheumatoid arthritis (RA). However, a specific approach to detect patients at higher risk of prosthetic joint infection (PJI) and mechanical complications is absent. The aim of this study is to identify groups at higher risk for infections and mechanical complications after TJA in patients with RA and OA based on their most significant predictors.
The Feasibility of Outpatient Revision Total Knee Arthroplasty in Selected Case Scenarios. [2022]As total knee arthroplasty (TKA) continues moving to the outpatient arena, the demand for revision surgery will subsequently increase which draws into question the feasibility for some revision scenarios as an outpatient. The purpose of this study is to report on the safety of outpatient revision knee arthroplasty.
Amputation as a Complication after Total Knee Replacement, is it a Real Concern to be Discussed?: A Systematic Review. [2021]Total knee replacement (TKR) is a growing attractive treatment for a degenerative knee disease. However, there remain some certain devastating complications to be discussed with patients preoperatively, including limb amputation. This systematic review aimed to determine the rate of amputation following TKR. In this study, the literature was searched up to 2019. The papers were included in which knee amputation was reported following TKR. The primary search concluded the articles from EMBASE, SCOPUS, PubMed, Web of Science, MEDLINE, OvidSP, CINAHL, EBSCO, Web of Science™, and CENTRAL. After screening and excluding case reports, 40 papers were included in the present study. The present review showed that amputation is a real end result of knee replacements either in primary or revision knee arthroplasties, which needs to be discussed with patients for their decision-making. Prevalence of amputation in terms of failure or complications after TKR procedures was estimated between 0.1-10% in different studies , with 5.1% amputation rate in infected TKR and 0.025% amputation rate in primary TKR as a result of infection in our review. Deep infection was the main cause of amputation. Vascular complications and fractures associated with bone loss and compartment syndrome were other reasons for amputation.
Extended length of stay and postoperative complications in octogenarians with hypertension following revision total knee arthroplasty. [2023]Prior studies have shown hypertensive patients to be at an increased risk of postoperative complications following various surgeries, including revision total knee arthroplasty (rTKA). However, whether these risks are compounded in octogenarian patients has not yet been well explored. The purpose of this study was to analyze whether hypertensive octogenarians, aged 80 to 89, undergoing rTKA are at an increased risk of postoperative complications relative to the younger hypertensive geriatric population aged 65 to 79.
Possible Risk Factors for Severe Complications Occurring after Primary Total Knee Arthroplasty. [2023]Objective Total knee arthroplasty is one of the most common orthopedic surgeries. Readmission due to severe complications after total knee arthroplasty is a grave concern to surgeons. In this study, we evaluated the risk factors for severe complications after primary total knee arthroplasty. Methods We retrospectively collected clinical data of 2,974 patients who underwent primary total knee arthroplasty from July 2013 to June 2019 in our hospital. Postoperative complication ≥ grade Ⅲ was defined as severe complication according to Clavien-Dindo classification system. Binary logistic regression was used to identify the predictive risk factors for severe complications. Results The complication rate after primary total knee arthroplasty was 6.8% and severe complication rate was 2.5%. Male (OR = 2.178, 95%CI: 1.324-3.585, P= 0.002), individuals above 75 years old (OR = 1.936, 95%CI: 1.155-3.244, P= 0.012), arrhythmia (OR = 2.913, 95%CI: 1.350-6.285, P= 0.006) and cerebrovascular disease (OR = 2.804, 95%CI: 1.432-5.489, P= 0.003) were predictive risk factors for severe complications after primary total knee arthroplasty. Conclusion Advanced age, male, arrhythmia, and cerebrovascular disease might be patients-related risk factors for postoperative severe complications after primary total knee arthroplasty. Special attention should be paid to patients with risk factors.
Study of femoral component malrotation as a cause of pain after total knee arthroplasty. [2023]The total knee arthroplasty (TKA) has been shown to be a successful and cost-benefit procedure in terms of pain improvement in patient with symptomatic knee osteoarthritis. However, almost a 20% of the patients are not satisfied with the result of the surgery.
Trend Shift in the Cause of Revision Total Knee Arthroplasty over 17 Years. [2023]The number of revision total knee arthroplasty (TKA) has been increasing. Although many studies have analyzed the causes of revision TKA in Western countries, a limited number of studies have analyzed changes in causes of or trends in revision TKA in Asia. This study analyzed and determined the frequency and causes of failures after TKA in our hospital. We also analyzed the differences and trends over the past 17 years.
Clinical outcomes and survival comparison between NexGen all-poly and its metal-backed equivalent in total knee arthroplasty. [2023]This study aims to compare total knee replacement (TKA) with NexGen All-Poly (APT) and NexGen Metal-Backed (MBT) in terms of implant survivorship, reasons leading to implant failure and functional results of defined age categories.