Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty(IPAKA)
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Trial details
- Who runs it
- Zhujiang Hospital
- Trial code
- NCT03763448
- Record updated
- 5 December 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Participants diagnosed with knee osteoarthritis by X-ray plain film (Kellgren-Lawrence score of ≥ 2); The need for TKA was confirmed after evaluation by the orthopedic surgeon; One week before surgery, knee pain 100mm pain visual analogue scale score was greater than 20mm; Understanding of the study requirements and willing to participate in this study.
Exclusion: Rheumatoid arthritis,psoriatic arthritis,lupus,malignant tumor; Suffering from somatic disease, psychiatric or cognitive disorders, neurological disorders that will compromise the safety, compliance, consent, participation, follow-up and the interpretation of the results; Requiring contralateral TKA within one year; The visual analogue score of 100mm of knee pain before operation was less than 20mm; Having a possible or planned pregnancy; With poor compliance; Severe knee valgus; Contraindications with TKA or MRI.