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

July 7, 2021 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ACL group
According to the previous clinical diagnosis, volunteers who has suffered the ACL injury.
This is an observation study, with no intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yong Ma, Doctor, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 8, 2021

Last Update Submitted That Met QC Criteria

July 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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