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NCT06704776 | RECRUITING | Total Knee Arthroplasty

The Medially Pedicled IPFP flap in TKA
Sponsor:

First Affiliated Hospital of Fujian Medical University

Information provided by (Responsible Party):

X in language fang

Brief 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.

Condition or disease

Total Knee Arthroplasty

Osteoarthritis (OA)

Intervention/treatment

"The medially pedicled IPFP flap" group

"Complete IPFP removal" group

Phase

NA

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 : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : DOUBLE
Masking Description : The researchers, outcome assessors and statisticians will be blinded to the group assignments and will not be involved in the trial operations. The patients will also be blinded to the group assignments. Due to the impossibility of blinding the surgeons, they will not be involved in any outcome assessments. Allocation results will be placed in sealed envelopes before the surgery. The envelopes will be opened prior to surgery after the administration of general anaesthesia.
Primary Purpose : TREATMENT
Official Title : The Medially Pedicled Infrapatellar Fat Pad (IPFP) flap in Total Knee Arthroplasty (TKA)
Actual Study Start Date : 2024-01-29
Estimated Primary Completion Date : 2025-01-29
Estimated Study Completion Date : 2026-01-29

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
The Medially Pedicled IPFP flap in TKA

Location Details

NCT06704776

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Locations

RECRUITING

China, Fujian

The First Affiliated Hospital of Fujian Medical University,

F U-axis, Fujian, China,