Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

Principal Investigators: Raymond Kim, MD and Johnny Huard, PhD

This study is being conducted at The Steadman Clinic and Steadman Philippon Research Institute. The purpose of the study is to evaluate the efficacy of a post-operative antifibrotic agent (Losartan) for reducing or preventing arthrofibrosis and improving patient-reported outcomes after total knee arthroplasty (TKA) in a randomized, placebo-controlled clinical trial. 

For additional information, please visit www.clinicaltrials.gov and search for: NCT06108063

Primary Objectives:

To evaluate between study arms:
 

1. Postoperative arthrofibrosis of the Study Knee at 3 months;
2. Postoperative function as assessed by physical assessment at 3 months.

Procedures Include:

• Review of medical record
• Collection of demographic information, medical history, current medications, and smoking status
• Pregnancy test if you are a woman of child-bearing age
• Collection of vital signs (blood pressure, heart rate)
• Blood draw
• Questionnaires
• Assessment of knee range of motion
• Assessment of knee strength
• Ultrasound of knee
• Administration of Losartan, an investigational study medication, or Placebo
• Recording of study drug doses in a log between visits

Eligibility Criteria:

Inclusion

Subjects may be included if all of the following criteria are met:
 

1. Planned primary total knee arthroplasty of a single knee;
2. Male or female ≥ 18 years of age;
3. Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments.

Exclusion

Subjects will be excluded if any of the following criteria are met:
 

1. Breastfeeding, pregnant, or planning to become pregnant during participation in the study; 
2. Diagnosed with inflammatory or other arthritis caused by autoimmune disease affecting the study knee;
3. Previous knee arthroplasty on the study knee;
4. Previous infection affecting the study knee;
5. Planned total knee arthroplasty of contralateral knee to occur at any point during the study participation period;
6. Are hypotensive as confirmed by Principal Clinical Investigator or appropriate designee;
7. Planned lower-extremity surgery (other than TKA in the study leg) for the duration of Study participation;
8. Any condition other than knee OA that significantly impairs ability to walk or perform other activities of daily living;
9. Currently taking Losartan or other medication in the same drug class; Warfarin or related anticoagulants;
10. Opioid analgesics taken in the past 8 weeks and are not willing to discontinue these medications through the duration of the study (except as prescribed as standard of care in the immediate post-operative period); 
11. Allergic to any active or inactive ingredient of Losartan;
12. Taking medication with known adverse Losartan interaction;
13. Subjects that have any medical condition, including malignancies, laboratory findings, and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation, or prevent the patient from fully participating in all aspects of the study.

If you would like more information about the study, please contact us at clinicaltrials@sprivail.org or 970-409-7566.