The Medially Pedicled IPFP flap in TKA

Launched by FIRST AFFILIATED HOSPITAL OF FUJIAN MEDICAL UNIVERSITY · Nov 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two different surgical approaches for patients undergoing total knee arthroplasty (TKA) due to knee osteoarthritis (OA). Specifically, the trial compares a method where a part of the knee tissue, called the IPFP, is preserved during surgery (the "medially pedicled IPFP flap" group) versus a method where this tissue is completely removed (the "complete IPFP removal" group). The goal is to see which approach leads to better recovery and knee function after surgery.

To participate in the trial, individuals must be between 40 and 80 years old and have a confirmed diagnosis of primary knee osteoarthritis. They should not have any history of previous knee surgeries or other serious health issues that could complicate the surgery. Participants will be randomly assigned to one of the two groups without knowing which one they are in and will be followed up at several points after the surgery to assess their knee function and overall recovery. Before joining the study, all participants will need to sign an informed consent form, ensuring they understand what the study involves.

Gender

ALL

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