Clinical trial NCT06704776: The Medially Pedicled IPFP ﬂap in TKA
Official title: The Medially Pedicled Infrapatellar Fat Pad (IPFP) ﬂap in Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Knee Osteoarthritis (OA)
Keywords: Total knee arthroplasty
IPFP
Knee osteoarthritis (OA)
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial employs a random allocation method. A randomization table will be generated using SPSS 26.0 software. Treatment groups will be selected based on patients' random numbers, ensuring that this clinical institution stratifies the subjects into an "The medially pedicled IPFP flap" group and a "Complete IPFP removal" group at a 1:1 ratio.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Intraoperative bleeding
timeFrame: 4 days postoperatively
measure: Postoperative visual analogue scale (VAS) scores at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
timeFrame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Total Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
timeFrame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: 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
timeFrame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Total morphine consumption during hospitalization
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: American Knee Society Knee Score (KSS)
timeFrame: 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Insall-Salvati Ratio (ISR)
timeFrame: 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Range of motion (ROM)
timeFrame: 3 weeks, 3 months, 6 months and 12 months after TKA
Other outcomes:
measure: Complete blood count
timeFrame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: C-reactive protein (CRP)
timeFrame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Interleukin-6 (IL-6)
timeFrame: 1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA
measure: Massachusetts Medical Imaging (MRI)
timeFrame: 3 months and 12 months after TKA
measure: Age
timeFrame: through study completion, an average of 1 year
measure: Sex
timeFrame: through study completion, an average of 1 year
measure: Operative site
timeFrame: through study completion, an average of 1 year
measure: BMI
timeFrame: through study completion, an average of 1 year
measure: Time to discharge
timeFrame: through study completion, an average of 1 year
measure: Incidence of Adverse events (AEs)
timeFrame: through study completion, an average of 1 year
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University,
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Wenming Zhang, MD
role: STUDY_DIRECTOR
References: