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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ultrasound: before surgery, 3 and 6 months post-surgery, samples: intra-operatively
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate the benefits of performing synovectomy during total knee arthroplasty (TKA) in patients with severe joint pain caused by synovitis. Synovectomy involves removing
Who is the study for?
This trial is for men and women over 40 with knee osteoarthritis, scheduled for their first total knee replacement. They must have moderate to severe joint inflammation as shown by ultrasound. Participants are being accepted from a specific hospital's Pre-Admission Clinic.
What is being tested?
The study tests if removing the inflamed tissue lining during knee replacement surgery (synovectomy) can reduce pain after the operation. Patients will be randomly assigned to receive either standard surgery or surgery with synovectomy, and their pain levels and quality of life will be compared before and after.
What are the potential side effects?
Potential side effects may include typical surgical risks like infection or bleeding, increased pain initially post-surgery due to the additional procedure, and possibly delayed healing or recovery time.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ultrasound: before surgery, 3 and 6 months post-surgery, samples: intra-operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ultrasound: before surgery, 3 and 6 months post-surgery, samples: intra-operatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Patients' self-reported level of pain
Secondary study objectives
Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)
Inflammation
Joint function - 30-Second Sit to Stand Test
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Total knee replacement with partial synovectomyExperimental Treatment1 Intervention
Patients in this arm will undergo partial synovectomy during total knee replacement surgery.
Group II: Total knee replacement without partial synovectomyActive Control1 Intervention
Patients in this arm will not undergo partial synovectomy during total knee replacement surgery.
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
421,633 Total Patients Enrolled
21 Trials studying Osteoarthritis
5,505 Patients Enrolled for Osteoarthritis
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