Clinical Application of the Apex of the Deep Cartilage in Evaluating the Femoral Tunnel of the ACL Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

Clinical Application of the Apex of the Deep Cartilage in Evaluating the Position of the Femoral Tunnel of the Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953546
• Other study ID #: M2021212
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Weili Shi, Doctor
• Phone: 18046529457
• Email: shiweilixmu[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the apex of the deep cartilage (ADC) as the symbol, the consistency of the two methods in the postoperatively computed tomography (CT) and microscopic evaluation of the position of the femoral tract of the anterior cruciate ligament (ACL) was studied.Expected results:P1 and P2, D1 and D2 were positively correlated, and the linear relationship was significant. Bland-Altman diagram shows a good consistency.

Description:

Objectives:

With the apex of the deep cartilage (ADC) as the symbol, the consistency of the two methods in the postoperatively computed tomography (CT) and microscopic evaluation of the position of the femoral tract of the anterior cruciate ligament (ACL) was studied.

Methods:

Prospective cohort study.

Fifty-two patients requiring arthroscopic anterior cruciate ligament reconstruction were enrolled in the Sports Medicine Department of Peking University Third Hospital.

Collect patients' basic information and preoperative conditions. During the operation, the patient's knee was bent 90°, and the center point was positioned according to the intact femoral stump. The horizontal distance from the ADC to the anterior bone margin (L1) and the horizontal distance from the center point of the bone tract (L1) were measured by the master, the first aid and the second aid, and the distance from the center point of the bone tract to the lower bone margin (D1) was measured, and the ratio of L1 /L1 was calculated (P1).

The horizontal distance from the ADC to the anterior bone margin (L2) and the horizontal distance from the center of the bone tract (L2) were measured by three investigators on postoperative CT films, and the distance from the center of the bone tract to the lower bone margin (D2) was also measured, and the ratio of L2 /L2 was calculated (P2).

Linear regression, Pearson correlation and Bland-Altman analysis were used to compare the consistency between the endoscopic assessment and CT assessment.

Expected results:

P1 and P2, D1 and D2 were positively correlated, and the linear relationship was significant. Bland-Altman diagram shows a good consistency.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.

• With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).

• All participants have no known disorders or diseases other than ACL rupture.

Exclusion Criteria:

• Other injuries affecting movement performance.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Other:
• No Intervention
This is an observation study, with no intervention

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The horizontal distance from the ADC to the anterior bone margin	The patients were measured microscopically at the time of surgery and again on CT after surgery.	On the 1 day of enrollment.
Primary	the horizontal distance from the center point of the bone tract	The patients were measured microscopically at the time of surgery and again on CT	On the 1 day of enrollment.
Primary	the distance from the center point of the bone tract to the lower bone margin	The patients were measured microscopically at the time of surgery and again on CT	On the 1 day of enrollment.