NCT06704776

The Medially Pedicled IPFP flap in TKA

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Fujian Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center prospective cohort study in which patients were evaluated by inclusion and exclusion criteria before total knee arthroplasty (TKA). This study aims to recruit 200 patients across a single centre over 1 year. Eligible patients will be included in this study after signing the informed consent form. Before TKA, the patients will be randomly assigned to either an experimental group ("The medially pedicled IPFP flap" group) or a control group ("complete IPFP removal" group) and administered different management of the IPFP during surgery. 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 primary outcomes are the intraoperative bleeding, the visual analogue scale (VAS) score and Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include American Knee Society Knee Score (KSS), Insall-Salvati Ratio (ISR) and knee joint range of motion (ROM). All patients voluntarily participated in the study and signed informed consent. During the treatment period, all prospective patients underwent clinical evaluation at the end of total knee arthroplasty and 3 weeks, 3 months, 6 months and 12 months later, aimed at comparing the postoperative pain and inflammatory response between "The medially pedicled IPFP flap" group and "complete IPFP removal" group, to explore the optimal perioperative analgesic modality for TKA. Statistical analyses utilizing regression models and survival analysis will be conducted to assess the relationships between the management of the IPFP and postoperative efficacy.

Conditions

• Total Knee Arthroplasty
• Knee Osteoarthritis (OA)

Interventions

Type	Name	Description
PROCEDURE	"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.
PROCEDURE	"Complete IPFP removal" group	The entire IPFP was resected from below the patellar tendon prior to femoral preparation.

Timeline

• Start date: 2024-01-29
• Primary completion: 2025-01-29
• Completion: 2026-01-29
• First posted: 2024-11-26
• Last updated: 2024-11-29

Locations

1 site across 1 country: China