NCT04937517

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 16, 2021

Last Update Submit

June 16, 2021

Conditions

ACL Injury

Keywords

femoral tunnelapex of the deep cartilage（ADC）

Outcome Measures

Primary Outcomes (6)

  • length from ADC to anterior cartilage margin (L1) under arthroscopy

    length from ADC to anterior cartilage margin (L1) under arthroscopy

    during operation

  • 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

  • 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

  • length from ADC to anterior cartilage margin (L2) on CT

    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

    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

    length from the center of femoral tunnel to the distal cartilage margin(D1) on CT

    1 day after operation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18-55 who need and suitable anterior cruciate ligament reconstruction

You may qualify if:

  • Adults aged 18-55 who need anterior cruciate ligament reconstruction

You may not qualify if:

  • Volunteers unsuitable for anterior cruciate ligament reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ma Yong

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23740328BACKGROUND

  • 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.

    PMID: 25274095BACKGROUND

  • 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.

    PMID: 25980920BACKGROUND

  • 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. 2023 Jan;31(1):256-263. doi: 10.1007/s00167-022-07090-4. Epub 2022 Aug 13.

    PMID: 35962841DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Yong Ma, M.D.

CONTACT

13581945087huidong01@sina.com

Weili Shi, M.D.

CONTACT

18046529457shiweilixmu@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 24, 2021

Study Start

May 25, 2021

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

Publication of academic papers

Locations

CN(1)