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Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial.

ABSTRACT: INTRODUCTION:The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure. However, our previous studies have suggested that IPFP size was protective against, while IPFP signal intensity alteration was detrimental on knee symptoms and structural abnormalities. We hypothesise that an IPFP with normal qualities, rather than abnormal qualities, should be preserved during TKA. The aim of this study is to compare, over a 1-year period, the postoperative clinical outcomes of IPFP preservation versus resection after TKA in patients with normal or abnormal IPFP signal intensity alteration on MRI. METHODS AND ANALYSIS:Three hundred and sixty people with end-stage knee osteoarthritis and on the waiting list for TKA will be recruited and identified as normal IPFP quality (signal intensity alteration score ?1) or abnormal IPFP quality (signal intensity alteration score ?2). Patients in each hospital will then be randomly allocated to IPFP resection group or preservation group. The primary outcomes are the summed score of self-reported Knee Injury and Osteoarthritis Outcome Score (KOOS), KOOS subscales assessing function in daily activities and function in sport and recreation. Secondary endpoints will be included: KOOS subscales (pain, symptoms and quality of life), Knee Society Score, 100?mm Visual Analogue Scale (VAS) Pain, timed up-and-go test, patellar tendon shortening, 100?mm VAS self-reported efficacy of reduced pain and increased quality of life, and Insall-Salvati index assessed on plain X-ray. Adverse events will be recorded. Intention-to-treat analyses will be used. ETHICS AND DISSEMINATION:The study is approved by the local Medical Ethics Committee (Zhujiang Hospital Ethics Committee, reference number 2017-GJGBK-001) and will be conducted according to the principle of the Declaration of Helsinki (64th, 2013) and the Good Clinical Practice standard, and in compliance with the Medical Research Involving Human Subjects Act . Data will be published in peer-reviewed journals and presented at conferences, both nationally and internationally. TRIAL REGISTRATION NUMBER:This trial was registered at Clinicaltrial.gov website on 19 October 2018 with identify number NCT03763448.

SUBMITTER: Zhu Z

PROVIDER: S-EPMC7590360 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial.

Zhu Zhaohua Z Han Weiyu W Lu Ming M Lin Jianhao J Yin Zongsheng Z Shang Xifu X Weng Xisheng X Zha Zhengang Z Tian Jin J Lei Guanghua G Hunter David J DJ Ding Changhai C

BMJ open 20201023 10

<h4>Introduction</h4>The infrapatellar fat pad (IPFP) is commonly resected during total knee arthroplasty (TKA) for better exposure. However, our previous studies have suggested that IPFP size was protective against, while IPFP signal intensity alteration was detrimental on knee symptoms and structural abnormalities. We hypothesise that an IPFP with normal qualities, rather than abnormal qualities, should be preserved during TKA. The aim of this study is to compare, over a 1-year period, the pos ...[more]

PMID: 33099502

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Project description:Background Infrapatellar fat pad (IPFP) quality has been implicated as a marker for predicting knee osteoarthritis (KOA); however, no valid quantification for subtle IPFP abnormalities has been established. Purpose To investigate whether MRI-based three-dimensional texture analysis of IPFP abnormalities could help predict incident radiographic KOA. Materials and Methods In this prospective nested case-control study, 690 participants whose knees were at risk for KOA were included from the Pivotal Osteoarthritis Initiative MRI Analyses incident osteoarthritis cohort. All knees had a Kellgren-Lawrence grade of 1 or less at baseline. During the 4-year follow-up, case participants were matched 1:1 to control participants, with incident radiographic KOA as the outcome. MRI scans were segmented at the incident time point of KOA (hereafter, P0), 1 year before P0 (hereafter, P-1), and baseline. MRI-based three-dimensional texture analysis was performed to extract IPFP texture features. Least absolute shrinkage and selection operator and multivariable logistic regressions were applied in the development cohort and evaluated in the test cohort. The area under the receiver operating characteristic curve (AUC) was used to evaluate the discriminative value of the clinical score, IPFP texture score, and MRI Osteoarthritis Knee Score. Results Participants were allocated to development (n = 500, 340 women; mean age, 60 years) and test (n = 190, 120 women; mean age, 61 years) cohorts. In both cohorts, IPFP texture scores (AUC ≥0.75 for all) showed greater discrimination than clinical scores (AUC ≤0.69 for all) at baseline, P-1, and P0, with significant differences in pairwise comparisons (P ≤ .002 for all). Greater predictive and concurrent validities of IPFP texture scores (AUC ≥0.75 for all) compared with MRI Osteoarthritis Knee Scores (AUC ≤0.66 for all) were also demonstrated (P < .001 for all). Conclusion MRI-based three-dimensional texture of the infrapatellar fat pad was associated with future development of knee osteoarthritis. ClinicalTrials.gov registration no.: NCT00080171 © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Fischer in this issue.

Project description:BackgroundThe infrapatellar fat pad (IPFP) plays an important role in the incidence of knee osteoarthritis (OA). Magnetic resonance (MR) signal heterogeneity of the IPFP is related to pathologic changes. In this study, we aimed to investigate whether the IPFP radiomic features have predictive value for incident radiographic knee OA (iROA) 1 year prior to iROA diagnosis.MethodsData used in this work were obtained from the osteoarthritis initiative (OAI). In this study, iROA was defined as a knee with a baseline Kellgren-Lawrence grade (KLG) of 0 or 1 that further progressed to KLG ≥2 during the follow-up visit. Intermediate-weighted turbo spin-echo knee MR images at the time of iROA diagnosis and 1 year prior were obtained. Five clinical characteristics-age, sex, body mass index, knee injury history, and knee surgery history-were obtained. A total of 604 knees were selected and matched (302 cases and 302 controls). A U-Net segmentation model was independently trained to automatically segment the IPFP. The prediction models were established in the training set (60%). Three main models were generated using (I) clinical characteristics; (II) radiomic features; (III) combined (clinical plus radiomic) features. Model performance was evaluated in an independent testing set (remaining 40%) using the area under the curve (AUC). Two secondary models were also generated using Hoffa-synovitis scores and clinical characteristics.ResultsThe comparison between the automated and manual segmentations of the IPFP achieved a Dice coefficient of 0.900 (95% CI: 0.891-0.908), which was comparable to that of experienced radiologists. The radiomic features model and the combined model yielded superior AUCs of 0.700 (95% CI: 0.630-0.763) and 0.702 (95% CI: 0.635-0.763), respectively. The DeLong test found no statistically significant difference between the receiver operating curves of the radiomic and combined models (P=0.831); however, both models outperformed the clinical model (P=0.014 and 0.004, respectively).ConclusionsOur results demonstrated that radiomic features of the IPFP are predictive of iROA 1 year prior to the diagnosis, suggesting that IPFP radiomic features can serve as an early quantitative prediction biomarker of iROA.

Dataset Information

Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial.

Publications

Effects of infrapatellar fat pad preservation versus resection on clinical outcomes after total knee arthroplasty in patients with knee osteoarthritis (IPAKA): study protocol for a multicentre, randomised, controlled clinical trial.

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