The Medially Pedicled Infrapatellar Fat Pad (IPFP) flap in Total Knee Arthroplasty (TKA)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). Eligible patients will be included in this study after signing the informed consent form. These patients will be randomly assigned to an experimental group (The medially pedicled IPFP flap group) and a control group (complete IPFP removal group). Patients were unaware of their grouping and were operated on by the same experienced surgeon. The surgical steps are identical except for the different management of the IPFP. Assessment of knee function will be performed at baseline, preoperatively, and during the 3 weeks, 3 months, 6 months and 12 months postoperative follow-up periods to evaluate the patients' prognostic outcomes. The study will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting parallel group randomised trials. Ethical approval will be obtained from each institution. Written informed consent will be obtained from all participants to ensure their voluntary participation and understanding of the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• clinical diagnosis of primary KOA confirmed by imaging (KL classification \>=2)

• Surgeon's opinion of eligibility for primary unilateral total knee arthroplasty (TKA) based on standard evaluation procedures

• Age: 40-80 years, male and female

• The patient volunteers to participate in the study by signing an informed consent form for either the 'medial attachment tipped IPFP flap' or the 'complete resection of the IPFP' approach.

• Patients understand the study requirements and are willing to co-operate with the study instructions.

Locations
Other Locations
China
The First Affiliated Hospital of Fujian Medical University,
RECRUITING
Fuzhou
Contact Information
Primary
Xinyu Fang, MD
9738006@qq.com
18084768503 Ext. 86
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2026-01-29
Participants
Target number of participants: 200
Treatments
Experimental: The medially pedicled IPFP flap group
In the The medially pedicled IPFP flap group, the IPFP was exposed and separated, and the lateral side was left intact and the medial side was tipped to form a complete medially tipped IPFP flap, and the IPFP flap was clipped and draped over the medial side to avoid interference of the IPFP with the operative field. After successful implantation of the prosthesis, the IPFP was fixed with in situ sutures.
Active_comparator: Complete IPFP removal group
In the Complete IPFP removal group, the entire IPFP was resected from below the patellar tendon prior to femoral preparation.
Sponsors
Leads: First Affiliated Hospital of Fujian Medical University

This content was sourced from clinicaltrials.gov