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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "The medially pedicled IPFP flap" group | Experimental | 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. |
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| "Complete IPFP removal" group | Active Comparator | In the "Complete IPFP removal" group, the entire IPFP was resected from below the patellar tendon prior to femoral preparation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "The medially pedicled IPFP flap" group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative bleeding | 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 | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| American Knee Society Knee Score (KSS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete blood count | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Fang, MD | Contact | 18084768503 Ext. 86 | 9738006@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenming Zhang, MD | First Affiliated Hospital of Fujian Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Fujian Medical University, | Recruiting | Fuzhou | Fujian | China |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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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.
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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.
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| "Complete IPFP removal" group | Procedure | The entire IPFP was resected from below the patellar tendon prior to femoral preparation. |
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| 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA |
| Total morphine consumption during hospitalization | 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 |
| 1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA |
| Insall-Salvati Ratio (ISR) | 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) | 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 |
| C-reactive protein (CRP) | 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) | 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) | 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) | 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 | Age in years will be obtained from the electronic medical records system. | through study completion, an average of 1 year |
| Sex | Sex (male or female) will be obtained from the electronic medical records system. | through study completion, an average of 1 year |
| Operative site | Operative site (left or right) will be obtained from the electronic medical records system. | through study completion, an average of 1 year |
| BMI | 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 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) | 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 |
| D012216 |
| Rheumatic Diseases |