Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Arthropathy of Knee
  • Knee Osteoarthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: participants, outcome assessors, data analysts and chief investigators are masked during the study procedure.Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 80 years
Gender
Both males and females

Description

Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and limited function in the elderly, and thus affects participants' quality of life. Total knee arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage osteoarthritic joint pain a...

Knee Osteoarthritis (KOA) is a common chronic disease, which often leads to joint pain and limited function in the elderly, and thus affects participants' quality of life. Total knee arthroplasty (TKA) has been developed as a mature surgical procedure to relieve end-stage osteoarthritic joint pain and improve limb function. Although more than 80% of the patients reported in the literature are satisfied with the postoperative efficacy of TKA, there are still a large number of patients whose daily life is affected by persistent knee pain and limited function after the operation of the affected limb. The IPFP is a fat mass located behind the patellar ligament, between the lower part of the patella and the tibial tubercle. The function of IPFP is controversial at present. It is reported that IPFP can provide blood supply for anterior cruciate ligament, patella and patellar ligament through the arterial network of the knee joint. In addition, it can fill the joint gap to lubricate the surface of the joint, reduce friction and absorb impulse so as to play a physiological protective role. On the contrary, studies have pointed out that abnormal IPFP could produce various pro-inflammatory cytokines such as interleukin (IL)-1?, tumour necrosis factor (TNF)-?, IL-6 and IL-8, as well as adipokines such as leptin and resistin, and thus might play a detrimental role in knee OA. Traditionally, the IPFP has been removed in order to improve surgical exposure and to prevent interposition during baseplate implantation. Despite the significant evolution of TKA technology which no longer requires the resection of IPFP for better surgical access, IPFP is still partially or totally resected in around 88% of TKAs. The investigators' previous population-based cohort study revealed that IPFP maximal area and volume were associated with reduced knee pain, decreased loss of cartilage volume and reduced risks of cartilage defect progression, indicating a beneficial effect of IPFP size. On the other hand, the investigators' further investigation demonstrated that IPFP signal intensity alteration was negatively associated with maximum area of IPFP, and moreover, associated with increased knee cartilage defects, subchondral bone marrow lesion (BML) and knee pain, suggesting IPFP with abnormal quality may play a detrimental role in knee OA. Based on these findings, the investigators proposed that IPFP with normal quality should be preserved or not damaged during TKA, while IPFP with abnormal quality should be resected. This multicentre randomised controlled trial is designed to test the investigators' hypotheses: in patients with normal IPFP quality, preservation of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP resection during TKA procedures; in patients with abnormal IPFP quality, resection of IPFP during TKA procedure will reduce postoperative knee symptoms and improve joint function, comparing with IPFP preservation during TKA procedures. The results would provide evidence-based recommendations on clinical practice to improve OA patients' postoperative outcomes. Three hundred and sixty eligible participants will be recruited and identified as having normal IPFP quality (signal intensity alteration score ? 1) or abnormal IPFP quality (signal intensity alteration score ? 2). Participants in each site will be randomly allocated to IPFP resection group or preservation group using computer-generated block randomisation.

Tracking Information

NCT #
NCT03763448
Collaborators
  • Peking Union Medical College Hospital
  • Peking University People's Hospital
  • Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Anhui Medical University
  • First Affiliated Hospital of Jinan University
  • Anhui Provincial Hospital
  • Tianjin Hospital
  • Affiliated Hospital of Youjiang Medical University for Nationalities
Investigators
Principal Investigator: Changhai Ding, MD Clinical Research Center of Zhujiang Hospital,Southern Medical University Principal Investigator: Jianhao Lin, MD Peking University People's Hospital Principal Investigator: Xisheng Weng, MD Peking Union Medical College Hospital Principal Investigator: Guanghua Lei, MD Xiangya Hospital of Central South University Principal Investigator: Zongsheng Yin, MD The First Affiliated Hospital of Anhui Medical University Principal Investigator: Zhengang Zha, MD First Affiliated Hospital of Jinan University Principal Investigator: Jing Tian, MD Zhujiang Hospital Principal Investigator: Xifu Shang, MD Anhui Provincial Hospital Principal Investigator: Yujin Tang, MD Affiliated Hospital of Youjiang Medical University for Nationalities Principal Investigator: Jun Liu, MD Tianjin Hospital