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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04937517
Other study ID # ADC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date July 31, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact Yong Ma, M.D.
Phone 13581945087
Email huidong01@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Adults aged 18-55 who need anterior cruciate ligament reconstruction Exclusion Criteria: - Volunteers unsuitable for anterior cruciate ligament reconstruction

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Ma Yong Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary length from ADC to anterior cartilage margin (L1) under arthroscopy length from ADC to anterior cartilage margin (L1) under arthroscopy during operation
Primary length from ADC to the center of femoral tunnel (l1) under arthroscopy length from ADC to the center of femoral tunnel (l1) under arthroscopy during operation
Primary length from the center of femoral tunnel to the distal cartilage margin(D1) under arthroscopy length from the center of femoral tunnel to the distal cartilage margin(D1) under arthroscopy during operation
Primary length from ADC to anterior cartilage margin (L2) on CT length from ADC to anterior cartilage margin (L2) on CT 1 day after operation
Primary length from ADC to the center of femoral tunnel (l1) on CT length from ADC to the center of femoral tunnel (l1) on CT 1 day after operation
Primary length from the center of femoral tunnel to the distal cartilage margin(D1) on CT length from the center of femoral tunnel to the distal cartilage margin(D1) on CT 1 day after operation
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