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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893875
• Other study ID #: SYSKY-2022-553-01
• Status: Recruiting
• Start date: January 31, 2021
• Est. completion date: December 28, 2023

Study information

• Verified date: May 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 28, 2023
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Athletic Injuries
• Wounds and Injuries

Locations

Country	Name	City	State
China	Sun Yatsen Memorial Hospital	Guang Zhou City	Guang Dong Province

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Score for pain (VAS)	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
Primary	Lysholm score	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
Primary	Tegner sacle	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