Exploring the Changes of Inflammatory Factors in Joint Fluid of Patients With Sports Injury for 1-year Postoperative Rehabilitation and Clinical Treatment

June 7, 2023 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
This study intends to use a prospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department from January 2020 to January 2022. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Detailed Description

This study intends to use a retrospective study design method to continuously collect immune cell and inflammatory factor data of 5ml peripheral blood and 10ml joint fluid from 200 patients who met the inclusion and exclusion criteria in our department starting from January 2021. The aim is to analyze the impact of changes in inflammatory factors before and after surgery on postoperative recovery. The indicators of postoperative rehabilitation for patients were objectively evaluated using three scales: Lysholm scale, VAS scale, and Tegner scale. Among them, the Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery; The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain; The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery.

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 (Estimated)

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guang Dong Province
      • Guang Zhou City, Guang Dong Province, China, 510120

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

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who underwent anterior cruciate ligament reconstruction surgery at the Sports Medicine Department of Sun Yat sen Memorial Hospital and required joint effusion extraction due to postoperative treatment

Description

Inclusion Criteria:

  • Those with healthy diet and regular exercise habits;
  • Sports injury patients(Satisfy one of the following conditions): Anterior cruciate ligament injury or meniscus injury

Exclusion Criteria:

  • Existence of underlying diseases related to the immune system;
  • Trauma leading to knee joint fracture;
  • Blood pressure, heart rate, vital capacity, muscle tension and other indicators are obviously abnormal;
  • Significant abnormalities in blood routine, infection indicators, heart, lung, liver, and kidney function tests, insufficient compensatory function of important organs, or severe systemic diseases;
  • Patients with neurological or psychiatric disorders, pregnant women, or a history of related illnesses combined with severe organic diseases

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

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
Visual Analog Score for pain (VAS)
Time Frame: Change from 2 weeks, 1 month, 3 months, 6 months, and 1 Year after ACLR operation
The VAS scale mainly evaluates the postoperative pain score of patients, with values ranging from 0 to 10. The higher the value, the more severe the pain;
Change from 2 weeks, 1 month, 3 months, 6 months, and 1 Year after ACLR operation
Lysholm score
Time Frame: Change from 6 months and 1 Year after ACLR operation
The Lysholm scale mainly evaluates the postoperative recovery of knee joint function in patients, with values ranging from 0 to 100. The higher the value, the better the recovery;
Change from 6 months and 1 Year after ACLR operation
Tegner sacle
Time Frame: Change from 6 months and 1 Year after ACLR operation
The Tegner scale is also mainly used to evaluate the postoperative recovery of knee joint function in patients, with values ranging from 0 to 10. The higher the value, the better the recovery
Change from 6 months and 1 Year after ACLR operation

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.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 (Actual)

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.
January 31, 2021

Primary Completion (Estimated)

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.
December 28, 2023

Study Completion (Estimated)

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.
December 28, 2023

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).
May 27, 2023

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.
June 7, 2023

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.
June 8, 2023

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.
June 8, 2023

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.
June 7, 2023

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.
May 1, 2023

More Information

Terms related to this study

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.
  • SYSKY-2022-553-01

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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