The Medially Pedicled IPFP flap in TKA

Not Applicable

Recruiting

• Conditions: Total Knee Arthroplasty; Knee Osteoarthritis (OA)

• Registration Number: NCT06704776
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-29
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-01-29
• Study Completion: 2026-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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.
Intraoperative bleeding	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.
Postoperative visual analogue scale (VAS) scores at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA	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.
Total Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA	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.
Total morphine consumption during hospitalization	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.

Secondary Outcome Measures

Name	Time	Method
American Knee Society Knee Score (KSS)	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.
Insall-Salvati Ratio (ISR)	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.
Range of motion (ROM)	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University,; 🇨🇳 Fuzhou, Fujian, China