Anterior Cruciate Ligament InjuriesNCT04953546
Clinical Application of the Apex of the Deep Cartilage in Evaluating the Femoral Tunnel of the ACL Reconstruction
An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion Criteria: Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
Who may be able to join
- 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.
Who cannot join
- Other injuries affecting movement performance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Yong Ma, Doctor, 13581945087, huidong01@sina.com
About this study
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
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- No Intervention
- Keywords
- anterior cruciate ligament, computed tomography, the apex of the deep cartilage, microscopic evaluation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an observation study, with no intervention
| Study group | Role | What they receive |
|---|---|---|
| ACL group | According to the previous clinical diagnosis, volunteers who has suffered the ACL injury. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the 1 day of enrollment.
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
Measured: On the 1 day of enrollment.
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
Measured: On the 1 day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jun 2021
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Ma, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953546
- Sponsor's protocol ID
- M2021212
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04953546
- Acronym / sponsor ID
- M2021212
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior cruciate ligament, computed tomography, the apex of the deep cartilage, microscopic evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL group | – | Other: No InterventionAccording to the previous clinical diagnosis, volunteers who has suffered the ACL injury. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion Criteria: Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Other injuries affecting movement performance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is an observation study, with no intervention | Other | ACL group |
Primary outcome
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yong Ma, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Shi, Doctor (18046529457, shiweilixmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The horizontal distance from the ADC to the anterior bone margin (time frame: On the 1 day of enrollment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2021.