- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04937517
ADC in Assessing Femoral Tunnel Position
June 16, 2021 updated by: Peking University Third Hospital
The Role of the Apex of the Deep Cartilage in Assessing Femoral Tunnel Position for Anterior Cruciate Ligament Reconstruction
To examine the consistency between postoperative CT scan and intraoperative arthroscopic measurement in evaluating femoral tunnel position for anterior cruciate ligament (ACL)reconstruction,both using the apex of the deep cartilage(ADC)as the marker.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The position of the center of femoral tunnel was decided in the complete femoral stub.
Then the length from the ADC to the anterior cartilage margin(L1)and to the center of femoral tunnel(l1),as well as the center to the distal cartilage margin(D1)were measured under arthroscopy and on post-operative CT scan(L2,l2 and D2).
Moreover,P1 and P2 were calculated through l1/L1 and l2/L2.
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
- Name: Yong Ma, M.D.
- Phone Number: 13581945087
- Email: huidong01@sina.com
Study Contact Backup
- Name: Weili Shi, M.D.
- Phone Number: 18046529457
- Email: shiweilixmu@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100000
- Recruiting
- Ma Yong
-
Contact:
- Weili Shi, M.D.
- Phone Number: +8618046529457
- Email: shiweilixmu@126.com
-
-
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adults aged 18-55 who need and suitable anterior cruciate ligament reconstruction
Description
Inclusion Criteria:
- Adults aged 18-55 who need anterior cruciate ligament reconstruction
Exclusion Criteria:
- Volunteers unsuitable for anterior cruciate ligament reconstruction
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: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
length from ADC to anterior cartilage margin (L1) under arthroscopy
Time Frame: during operation
|
length from ADC to anterior cartilage margin (L1) under arthroscopy
|
during operation
|
length from ADC to the center of femoral tunnel (l1) under arthroscopy
Time Frame: during operation
|
length from ADC to the center of femoral tunnel (l1) under arthroscopy
|
during operation
|
length from the center of femoral tunnel to the distal cartilage margin(D1) under arthroscopy
Time Frame: during operation
|
length from the center of femoral tunnel to the distal cartilage margin(D1) under arthroscopy
|
during operation
|
length from ADC to anterior cartilage margin (L2) on CT
Time Frame: 1 day after operation
|
length from ADC to anterior cartilage margin (L2) on CT
|
1 day after operation
|
length from ADC to the center of femoral tunnel (l1) on CT
Time Frame: 1 day after operation
|
length from ADC to the center of femoral tunnel (l1) on CT
|
1 day after operation
|
length from the center of femoral tunnel to the distal cartilage margin(D1) on CT
Time Frame: 1 day after operation
|
length from the center of femoral tunnel to the distal cartilage margin(D1) on CT
|
1 day after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hofbauer M, Muller B, Murawski CD, van Eck CF, Fu FH. The concept of individualized anatomic anterior cruciate ligament (ACL) reconstruction. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):979-86. doi: 10.1007/s00167-013-2562-4. Epub 2013 Jun 6. Review.
- Inderhaug E, Larsen A, Strand T, Waaler PA, Solheim E. The effect of feedback from post-operative 3D CT on placement of femoral tunnels in single-bundle anatomic ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2016 Jan;24(1):154-60. doi: 10.1007/s00167-014-3355-0. Epub 2014 Oct 2.
- Hart A, Han Y, Martineau PA. The Apex of the Deep Cartilage: A Landmark and New Technique to Help Identify Femoral Tunnel Placement in Anterior Cruciate Ligament Reconstruction. Arthroscopy. 2015 Sep;31(9):1777-83. doi: 10.1016/j.arthro.2015.03.026. Epub 2015 May 15.
- Shi W, Zhang J, Meng Q, Chen N, Shen Q, Li S, Cao Z, Ao Y, Ma Y. The apex of the deep cartilage is a stable landmark to evaluate the femoral tunnel position in ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2022 Aug 13. doi: 10.1007/s00167-022-07090-4. Online ahead of print.
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)
May 25, 2021
Primary Completion (Anticipated)
July 31, 2021
Study Completion (Anticipated)
July 31, 2021
Study Registration Dates
First Submitted
June 16, 2021
First Submitted That Met QC Criteria
June 16, 2021
First Posted (Actual)
June 24, 2021
Study Record Updates
Last Update Posted (Actual)
June 24, 2021
Last Update Submitted That Met QC Criteria
June 16, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Publication of academic papers
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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