NCT05893875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2023

Enrollment Period

2.9 years

First QC Date

May 27, 2023

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yatsen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2023

First Posted

June 8, 2023

Study Start

January 31, 2021

Primary Completion

December 28, 2023

Study Completion

December 28, 2023

Last Updated

June 8, 2023

Record last verified: 2023-05

Locations