Clinical trial NCT04953546: Clinical Application of the Apex of the Deep Cartilage in Evaluating the Femoral Tunnel of the ACL Reconstruction
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Injuries
Keywords: anterior cruciate ligament
computed tomography
the apex of the deep cartilage
microscopic evaluation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria: Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The horizontal distance from the ADC to the anterior bone margin
timeFrame: On the 1 day of enrollment.
measure: the horizontal distance from the center point of the bone tract
timeFrame: On the 1 day of enrollment.
measure: the distance from the center point of the bone tract to the lower bone margin
timeFrame: On the 1 day of enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Yong Ma, Doctor
role: STUDY_CHAIR
References: