Comparing two surgical techniques for knee replacement
The Medially Pedicled Infrapatellar Fat Pad (IPFP) flap in Total Knee Arthroplasty (TKA)
NA · First Affiliated Hospital of Fujian Medical University · NCT06704776
This study is testing two different surgical methods for knee replacement to see which one helps people with knee osteoarthritis recover better and have less pain.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University (other) |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06704776 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of two different surgical techniques during total knee arthroplasty (TKA) for patients with knee osteoarthritis. Patients will be randomly assigned to either the experimental group, which uses a medially pedicled infrapatellar fat pad (IPFP) flap, or the control group, which involves complete removal of the IPFP. The study will assess knee function and other outcomes at multiple time points post-surgery, including intraoperative bleeding and pain levels. The research aims to determine which technique provides better prognostic outcomes for patients undergoing TKA.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40-80 with a clinical diagnosis of primary knee osteoarthritis eligible for unilateral total knee arthroplasty.
Not a fit: Patients with previous knee surgeries, other types of arthritis, or severe osteoarthritis complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and pain management for patients undergoing knee replacement surgery.
How similar studies have performed: While similar approaches have been explored, this specific technique of using a medially pedicled IPFP flap in TKA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University, — Fuzhou, Fujian, China (RECRUITING)
Study contacts
- Study coordinator: Xinyu Fang, MD
- Email: 9738006@qq.com
- Phone: 18084768503 Ext. 86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Knee Arthroplasty, Knee Osteoarthritis, Total knee arthroplasty, IPFP, Knee osteoarthritis