The Medially Pedicled IPFP flap in TKA

NCT06704776 | Unknown

• 1 other identifier: MRCTA, ECFAH of FMU|2023]376
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Knee Osteoarthritis (OA)

Keywords

Total knee arthroplasty; IPFP; Knee osteoarthritis (OA)

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Secondary Outcomes (3)

• American Knee Society Knee Score (KSS)

  1-5 days, 3 weeks, 3 months, 6 months and 12 months after TKA

• Insall-Salvati Ratio (ISR)

  3 weeks, 3 months, 6 months and 12 months after TKA

• Range of motion (ROM)

  3 weeks, 3 months, 6 months and 12 months after TKA

Other Outcomes (11)

• Complete blood count

  1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA

• C-reactive protein (CRP)

  1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA

• Erythrocyte sedimentation rate (ESR)

  1 day, 4 days, 3 weeks, 3 months, 6 months and 12 months after TKA

Study Arms (2)

"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.

Procedure: "The medially pedicled IPFP flap" group

"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.

Procedure: "Complete IPFP removal" group

Interventions

"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.

"The medially pedicled IPFP flap" group

"Complete IPFP removal" group PROCEDURE

The entire IPFP was resected from below the patellar tendon prior to femoral preparation.

"Complete IPFP removal" group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of previous surgical knee surgery or surgical knee infection
• Patients with a diagnosis other than osteoarthritis (including rheumatoid arthritis, traumatic arthritis, septic arthritis and haemophilic arthritis)
• Severe osteoarthritis (including flexion contracture \>30 or inversion/eversion deformity \>30, and use of non-traditional restrictive joint prosthesis due to complex joint pathology)
• presence of neuromuscular dysfunction on the operated side
• The surgeon considers that other surgical modalities (UKA, HTO, revision surgery) are appropriate for treatment according to the standard assessment process
• The patient decides to use other partial IPFP preservation options
• 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
• Concurrent participation in a clinical trial other than this trial
• Patients who, in the judgement of the investigator, no longer meet the criteria for the study due to adherence issues

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University,

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wenming Zhang, MD

  First Affiliated Hospital of Fujian Medical University

  STUDY DIRECTOR

Central Study Contacts

Xinyu Fang, MD

CONTACT

18084768503 Ext. 86; 9738006@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: January 29, 2024
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-01

Locations

CN (1)