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The Medially Pedicled IPFP flap in TKA

NCT ID: NCT06704776

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-01-29

Brief Summary

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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.

Detailed Description

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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). 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.

Conditions

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Total Knee Arthroplasty Knee Osteoarthritis (OA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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"The medially pedicled IPFP flap" group

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.

Group Type EXPERIMENTAL

"The medially pedicled IPFP flap" group

Intervention Type 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.

"Complete IPFP removal" group

In the "Complete IPFP removal" group, the entire IPFP was resected from below the patellar tendon prior to femoral preparation.

Group Type ACTIVE_COMPARATOR

"Complete IPFP removal" group

Intervention Type PROCEDURE

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

Interventions

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"The medially pedicled IPFP flap" group

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.

Intervention Type PROCEDURE

"Complete IPFP removal" group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xinyu Fang

Deputy chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenming Zhang, MD

Role: STUDY_DIRECTOR

First Affiliated Hospital of Fujian Medical University

Locations

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The First Affiliated Hospital of Fujian Medical University,

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinyu Fang, MD

Role: CONTACT

[email protected]
18084768503 Ext. 86

Facility Contacts

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Fang, MD

Role: primary

[email protected]
18084768503 Ext. 86

Other Identifiers

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MRCTA, ECFAH of FMU|2023]376

Identifier Type: -

Identifier Source: org_study_id