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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05893875
Collaborator
(none)
200
1
34.9
5.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Exploring the Changes of Inflammatory Factors in Joint Fluid of Patients With Sports Injury for 1-year Postoperative Rehabilitation and Clinical Treatment
    Actual Study Start Date :
    Jan 31, 2021
    Anticipated Primary Completion Date :
    Dec 28, 2023
    Anticipated Study Completion Date :
    Dec 28, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Score for pain (VAS) [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;

    2. Lysholm score [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;

    3. Tegner sacle [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yatsen Memorial Hospital Guang Zhou City Guang Dong Province China 510120

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    ClinicalTrials.gov Identifier:
    NCT05893875
    Other Study ID Numbers:
    • SYSKY-2022-553-01
    First Posted:
    Jun 8, 2023
    Last Update Posted:
    Jun 8, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2023