ACL InjuryNCT04937517
ADC in Assessing Femoral Tunnel Position
An observational study of ACL Injury, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2021to 31 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults aged 18-55 who need and suitable anterior cruciate ligament reconstruction
Who may be able to join
- Adults aged 18-55 who need anterior cruciate ligament reconstruction
Who cannot join
- Volunteers unsuitable for anterior cruciate ligament reconstruction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ma Yong
Beijing, Beijing Municipality, 100000
Weili Shi, M.D., +8618046529457, shiweilixmu@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- ACL Injury
- Keywords
- femoral tunnel, apex of the deep cartilage（ADC）
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
length from ADC to anterior cartilage margin (L1) under arthroscopy
length from ADC to anterior cartilage margin (L1) under arthroscopy
Measured: 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
Measured: 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
Measured: during operation
length from ADC to anterior cartilage margin (L2) on CT
length from ADC to anterior cartilage margin (L2) on CT
Measured: 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
Measured: 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
Measured: 1 day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start25 May 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies 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
- Case only
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937517
- Sponsor's protocol ID
- ADC
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of academic papers
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.
PubMed 23740328Inderhaug 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.
PubMed 25274095Hart 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.
PubMed 25980920Shi 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.
PubMed 35962841
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Apex of the Deep Cartilage in Assessing Femoral Tunnel Position for Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04937517
- Acronym / sponsor ID
- ADC
- Conditions
- ACL Injury
- Keywords
- femoral tunnel, apex of the deep cartilage（ADC）
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 24 Jun 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults aged 18-55 who need and suitable anterior cruciate ligament reconstruction
Key inclusion criteria (1 listed)
- Adults aged 18-55 who need anterior cruciate ligament reconstruction
Key exclusion criteria (1 listed)
- Volunteers unsuitable for anterior cruciate ligament reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
length from ADC to anterior cartilage margin (L1) under arthroscopy
Time frame: during operation
length from ADC to anterior cartilage margin (L1) under arthroscopy
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Background: PubMed 23740328Hofbauer 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.
- Background: PubMed 25274095Inderhaug 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.
- Background: PubMed 25980920Hart 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.
- Derived from this study: PubMed 35962841Shi 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.
- Individual participant dataSharing planned: Yes. Publication of academic papers
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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.
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 ACL Injury, 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 1 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 24 Jun 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 Yong Ma, M.D. (13581945087, huidong01@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length from ADC to anterior cartilage margin (L1) under arthroscopy (time frame: during operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937517, which also lists 4 linked publications.
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 24 Jun 2021.