At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty in Patients With Knee Osteoarthritis - A Multicenter Randomized Controlled Clinical Trial
In Brief
A clinical study evaluating Infrapatellar Fat Pad preservation and Infrapatellar Fat Pad resection for Knee Osteoarthritis and Arthropathy of Knee. Completed, enrolled 377 participants across 1 site.
Detailed Summary
This study aims to compare the postoperative clinical outcomes of Infrapatellar Fat Pad (IPFP) preservation versus resection after total knee arthroplasty (TKA) in patients with knee osteoarthritis. Participants will be identified as normal IPFP or abnormal IPFP based on MRI findings before randomization. The primary outcome is the change from baseline to 12 months in the mean score on five Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS5), covering pain, symptoms, activities of daily life, sport \& recreation, knee-related quality of life, with scores ranging from 0 (worst) to 100 (best). The secondary endpoints will be included: KOOS subscales, Knee Society Score (KSS), 100 mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, depression, patellar tendon shortening, 100 mm VAS self-reported efficacy of reduced pain and increased quality of life. Adverse events will be recorded. Primary and secondary outcomes will be evaluated or reported blindly at baseline and at postoperative 3 months, 6 months, and 1 year. Intention-to-treat analyses will be used.
Study Details
Timeline
Interventions
In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.
In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.