Infrapatellar Fat Pad Preservation Versus Resection on Clinical Outcomes After Total Knee Arthroplasty(IPAKA)

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.

Conditions

• Knee Osteoarthritis
• Arthropathy of Knee

Interventions

PROCEDURE

Infrapatellar Fat Pad preservation

In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.

PROCEDURE

Infrapatellar Fat Pad resection

In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.

Sponsors & Collaborators

• Peking University People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Tianjin Hospital

  collaborator OTHER

• Youjiang Medical College for Nationalities

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Zhujiang Hospital

  lead OTHER

Principal Investigators

• Changhai Ding, MD · Clinical Research Center of Zhujiang Hospital,Southern Medical University

• Jianhao Lin, MD · Peking University People's Hospital

• Xisheng Weng, MD · Peking Union Medical College Hospital

• Guanghua Lei, MD · Xiangya Hospital of Central South University

• Zongsheng Yin, MD · The First Affiliated Hospital of Anhui Medical University

• Zhengang Zha, MD · First Affiliated Hospital of Jinan University

• Jing Tian, MD · Zhujiang Hospital

• Xifu Shang, MD · Anhui Provincial Hospital

• Yujin Tang, MD · Youjiang Medical College for Nationalities

• Jun Liu, MD · Tianjin Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-17

Primary Completion

2024-05-13

Completion

2024-05-13

Countries

• China

Study Locations