The Medially Pedicled IPFP flap in TKA

November 26, 2024 updated by: Xinyu Fang, First Affiliated Hospital of Fujian Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xinyu Fang, MD
  • Phone Number: 18084768503 Ext. 86
  • Email: 9738006@qq.com

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. clinical diagnosis of primary KOA confirmed by imaging (KL classification >=2)
  2. Surgeon's opinion of eligibility for primary unilateral total knee arthroplasty (TKA) based on standard evaluation procedures
  3. Age: 40-80 years, male and female
  4. 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.
  5. Patients understand the study requirements and are willing to co-operate with the study instructions.

Exclusion Criteria:

  1. History of previous surgical knee surgery or surgical knee infection
  2. Patients with a diagnosis other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis)
  3. Severe osteoarthritis (including flexion contracture >30 or inversion/eversion deformity >30, and use of non-traditional restrictive joint prosthesis due to complex joint pathology)
  4. presence of neuromuscular dysfunction on the operated side
  5. The surgeon considers that other surgical modalities (UKA, HTO, revision surgery) are appropriate for treatment according to the standard assessment process
  6. The patient decides to use other partial IPFP preservation options
  7. Poor overall health conditions, including but not limited to a glycated haemoglobin level exceeding 12%, blood pressure exceeding 170/110 mmHg, myocardial infarction, stroke, transient ischaemic attack, acute congestive heart failure, or any acute coronary events within the past 6 months, severe hepatic or renal dysfunction, pregnancy, lactation and possible or planned pregnancy, history of psoriatic arthritis, lupus or cancer and psychiatric, cognitive and/or neurological disorders
  8. Concurrent participation in a clinical trial other than this trial
  9. Patients who, in the judgement of the investigator, no longer meet the criteria for the study due to adherence issues

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Procedure: "Complete IPFP removal" group
The entire IPFP was resected from below the patellar tendon prior to femoral preparation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative bleeding
Time Frame: 4 days postoperatively
Intraoperative bleeding will be estimated by subtracting the preoperative hemoglobin level from the hemoglobin level measured 24 hours postoperatively and the preoperative hemoglobin level from the hemoglobin level measured 4 days postoperatively.
4 days postoperatively
Postoperative visual analogue scale (VAS) scores at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Time Frame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
VAS scores are the most commonly used indicator for assessing the intensity of patient pain. The scale ranges from "0" to "10", where "0" indicates no pain and "10" represents the most severe pain that is unbearable. Patients will rate their pain based on subjective perceptions. In this trial, VAS scores will be recorded once before TKA. The VAS scores will be assessed separately for the resting and flexion states. If the patient's hospitalization period is shorter than 72 hours, the VAS score at discharge will be recorded instead of that at 72 hours. The results will be used to evaluate whether "IPFP flap with pedicle medial attachment " can reduce pain after TKA.
1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Total Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Time Frame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
The KOOS is a patient-reported questionnaire for the knee that includes 42 items in five separately analysed subscales for pain, other symptoms, function in daily living, sport and recreational function and knee-related quality of life.Scores from 0-100 will be converted to the appropriate scale, with 0 representing severe knee problems and 100 representing no problems.The KOOS has been validated for use in TKA and has been shown to be a valid and reliable assessment measure.
1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales for pain at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Time Frame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
The KOOS is a patient-reported questionnaire for the knee that includes 42 items in five separately analysed subscales for pain, other symptoms, function in daily living, sport and recreational function and knee-related quality of life.Scores from 0-100 will be converted to the appropriate scale, with 0 representing severe knee problems and 100 representing no problems.The KOOS has been validated for use in TKA and has been shown to be a valid and reliable assessment measure.
1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Total morphine consumption during hospitalization
Time Frame: through study completion, an average of 6 months
It will be converted to total morphine equivalents and will include both the postoperative routine pain management regimen and extra analgesia.
through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
American Knee Society Knee Score (KSS)
Time Frame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
The KSS score is a comprehensive scoring system consisting of two components: the knee score and the functional score. The knee score includes ratings of pain, mobility, and stability, with a subtraction for knee deformity. The functional score includes ratings of walking ability and ability to walk up and down stairs. Both scores range from 0-100, with higher scores being associated with better function.The KSS has been used to document and report postoperative functional outcomes of TKA worldwide.
1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Insall-Salvati Ratio (ISR)
Time Frame: 3 weeks, 3 months, 6 months and 12 months after TKA
The Insall-Salvati Ratio (ISR) is used to assess changes in patellar tendon length at baseline and at 3 weeks, 3 months, 6 months, and 12 months postoperatively. Experienced radiographers will use standardised radiography to take lateral photographs of the knee flexed at approximately 30° The numerator of the ISR is the length of the patellar tendon (the distance from the inferior aspect of the patella to the superior aspect of the tibial tuberosity on the lateral radiograph) The denominator of the ISR is the longest dimension of the patella on the lateral radiograph.
3 weeks, 3 months, 6 months and 12 months after TKA
Range of motion (ROM)
Time Frame: 3 weeks, 3 months, 6 months and 12 months after TKA
The range of motion (ROM) will be measured with a protractor thrice daily at 6-hour intervals, and the best value on each day will be used in the analysis. The range of motion (ROM) is from 0 to 180 degrees. The larger the angle, the more satisfactory the recovery of joint function.
3 weeks, 3 months, 6 months and 12 months after TKA

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete blood count
Time Frame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
A complete blood count (CBC) can reflect the patient's postoperative inflammatory status. It measures various components of the blood, including white blood cells, red blood cells, and platelets, which can indicate the presence of inflammation or infection. An elevated white blood cell count, for example, is often associated with an inflammatory response.
1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
C-reactive protein (CRP)
Time Frame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
C-reactive protein (CRP) can reflect the patient's postoperative inflammatory status.
1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Erythrocyte sedimentation rate (ESR)
Time Frame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Erythrocyte sedimentation rate (ESR) can reflect the patient's postoperative inflammatory status.
1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Interleukin-6 (IL-6)
Time Frame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Interleukin-6 (IL-6) can reflect the patient's postoperative inflammatory status.
1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
Massachusetts Medical Imaging (MRI)
Time Frame: 3 months and 12 months after TKA
MRI can be used to assess the position of the prosthesis and the status of the surrounding soft tissues after TKA.
3 months and 12 months after TKA
Age
Time Frame: through study completion, an average of 1 year
Age in years will be obtained from the electronic medical records system.
through study completion, an average of 1 year
Sex
Time Frame: through study completion, an average of 1 year
Sex (male or female) will be obtained from the electronic medical records system.
through study completion, an average of 1 year
Operative site
Time Frame: through study completion, an average of 1 year
Operative site (left or right) will be obtained from the electronic medical records system.
through study completion, an average of 1 year
BMI
Time Frame: through study completion, an average of 1 year
Weight (kg) and height (m) will be combined to report BMI in kg/m^2, which will be obtained from the electronic medical records system. This information will be collected by the same evaluator and used to calculate the age-corrected Charlson Comorbidity Index (aCCI), baseline ROM, HSS score and VAS score for these patients.
through study completion, an average of 1 year
Time to discharge
Time Frame: through study completion, an average of 1 year
Time to discharge will be sourced from the electronic medical records system and used to evaluate the impacts of PSIA and PLIA on the surgical process and postoperative recovery.
through study completion, an average of 1 year
Incidence of Adverse events (AEs)
Time Frame: through study completion, an average of 1 year
Adverse events (AEs) are adverse medical events that occur in clinical trial subjects after receiving treatment. In this study, total AEs will be mainly categorized into local AEs and systemic AEs. Local AEs include but are not limited to prolonged wound drainage (wound drainage persists on postoperative day 3, and the drainage area of the wound dressing is greater than 2×2 cm , poor wound healing and prosthetic joint infection. Systemic AEs include but are not limited to deep vein thrombosis events, systemic infection and serious adverse events such as pulmonary embolism and death.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Fujian Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Wenming Zhang, MD, First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 29, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MRCTA, ECFAH of FMU|2023]376

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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