The Correlation Between Femoral Component Implanting Flexion Angle and Posterior Condyle Offset in Cruciate Retaining Total Knee Arthroplasty

July 27, 2022 updated by: RenJi Hospital
The main aim and scope is making measurement and comparison about the femoral component posterior offset under different femoral component implanting flexion angle in cruciate retaining total knee arthroplasty. The results may identify the influence of the flexion component implanting flexion angle on the femoral component posterior offset.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients were treated with primary total knee arthroplasty in Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine.

Description

Inclusion Criteria:

  • The patients undertaken the primary cruciate retaining total knee arthroplasty;
  • using the curiate retaining total knee arthroplasty prothesis from Biomet and Smith&Nephew;
  • Complete surgery documents and radiologic data,such as standard X-ray postoperative both at antirior-posterior position and medial-lateral position(overlap of the medial and lateral femoral condyle).

Exclusion Criteria:

  • The patients without standard X-ray postoperative both at antirior-posterior position and medial-lateral position(poor overlap of the medial and lateral femoral condyle);
  • Complex primary total knee arthroplasty, using extra component such as trabecular metal,stem or et al.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
The group that the sagittal flexion angle of the femoral component less than 4°
The patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component less than 4° were categorized into this group.
Procedure: total knee arthroplasty
The surgeries were performed under general anesthesia. The medial parepatellar incision was introduced during the TKA. The femoral component size was selected according to the intro-operative measurement. The osteotomy was done according to the intramedullary guide and the cutting guide. After the proximal tibial osteotomy was finished, the cruciate-retaining Total Knee System was used. The lateral rotation of the femoral component was determined by the gap-balancing technique.
The group that the sagittal flexion angle of the femoral component over 4°
The patients' knees were taken on the X-ray examination after the total knee arthroplasty on the medial-lateral position. The flexion (positive degree) or extension (negative degree) angle of the femoral component according to the anterior femoral cortex was measured. The patients with the sagittal flexion angle of the femoral component over 4° were categorized into this group.
Procedure: total knee arthroplasty
The surgeries were performed under general anesthesia. The medial parepatellar incision was introduced during the TKA. The femoral component size was selected according to the intro-operative measurement. The osteotomy was done according to the intramedullary guide and the cutting guide. After the proximal tibial osteotomy was finished, the cruciate-retaining Total Knee System was used. The lateral rotation of the femoral component was determined by the gap-balancing technique.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Posterior Femoral Offset
Time Frame: 1 week after the surgery
The posterior femoral offset was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex on the medial-lateral position of the X-ray examination.
1 week after the surgery
Posterior Femoral Offset Ratio
Time Frame: 1 week after the surgery
The posterior femoral offset ratio was defined as the maximal thickness of the posterior condyle projecting posteriorly to a straight line drawn as the extension of the posterior femoral shaft cortex, divided by the maximal thickness of the posterior condyle projecting posterior to a straight line drawn as the extension of the anterior femoral shaft contex on the medial-lateral position of the X-ray examination.
1 week after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT-2022-0048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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