- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04953546
Clinical Application of the Apex of the Deep Cartilage in Evaluating the Femoral Tunnel of the ACL Reconstruction
Clinical Application of the Apex of the Deep Cartilage in Evaluating the Position of the Femoral Tunnel of the Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Weili Shi, Doctor
- Phone Number: 18046529457
- Email: shiweilixmu@126.com
Study Locations
-
-
-
Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
Contact:
- Yong Ma, Doctor
- Phone Number: 13581945087
- Email: huidong01@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Study Chair: Yong Ma, Doctor, Peking University Third Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2021212
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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