Anterior Cruciate Ligament InjuriesNCT04956536
Anterior Tibial Subluxation in the Setting of ACL-injury and After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Injuries, run by Peking University Third Hospital at 1 site in China.
Trial summary
To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Demographic data and MRI images were extracted and analyzed
- How many people
- 297 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ACL-injured patients that had suffered from ACL injury and underwent primary ACL reconstruction between January 1, 2013 and December 31, 2015.
Who may be able to join
- Diagnosed anterior cruciate ligament injuries
- Available preoperative MRI images at our hospital
Who cannot join
- Patients were excluded in the case of under 18 years of age
- Bilateral anterior cruciate ligament injuries
- Concomitant posterior cruciate ligament injuries
- Concomitant collateral ligament injuries
- No access to the preoperative MRI scan at our hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Injury and After Anterior Cruciate Ligament Reconstruction
To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images.
Read the detailed description
Demographic data and MRI images of anterior cruciate ligament-injured patients were retrospectively analyzed. Anterior tibial subluxation was measured and factors were examined via univariate and multivariate analysis.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Demographic data and MRI images were extracted and analyzed
- Keywords
- anterior tibial subluxation
- 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.
Demographic data and MRI images were extracted and analyzedOther
Demographic data and MRI images were extracted and analyzed. Related factors for anterior tibial subluxation were examined in anterior cruciate ligament-injured patients.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Anterior cruciate ligament-injured patients Receives: Other: Demographic data and MRI images were extracted and analyzed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior tibial subluxation
Anterior tibial subluxation was measured preoperatively.
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Dec 2020
- Primary completion1 Jan 2021
- Study completion1 Jul 2026 (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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng Wang, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956536
- Sponsor's protocol ID
- M2020433
- Status last verified
- Nov 2023
- First submitted
- 30 Jun 2021
- Last updated
- 22 Nov 2023
- Results posted
- 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 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Injury and After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04956536
- Acronym / sponsor ID
- M2020433
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior tibial subluxation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 297 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 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.
To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images.
Detailed description
Demographic data and MRI images of anterior cruciate ligament-injured patients were retrospectively analyzed. Anterior tibial subluxation was measured and factors were examined via univariate and multivariate analysis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Demographic data and MRI images were extracted and analyzedAnterior cruciate ligament-injured patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACL-injured patients that had suffered from ACL injury and underwent primary ACL reconstruction between January 1, 2013 and December 31, 2015.
Key inclusion criteria (2 listed)
- Diagnosed anterior cruciate ligament injuries
- Available preoperative MRI images at our hospital
Key exclusion criteria (5 listed)
- Patients were excluded in the case of under 18 years of age
- Bilateral anterior cruciate ligament injuries
- Concomitant posterior cruciate ligament injuries
- Concomitant collateral ligament injuries
- No access to the preoperative MRI scan at our hospital
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 |
|---|---|---|
| Demographic data and MRI images were extracted and analyzedDemographic data and MRI images were extracted and analyzed. Related factors for anterior tibial subluxation were examined in anterior cruciate ligament-injured patients. | Other | Group 1 |
Primary outcome
Anterior tibial subluxation
Time frame: Preoperatively
Anterior tibial subluxation was measured preoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
Cheng Wang, M.D. 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 2 inclusion and 5 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 22 Nov 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior tibial subluxation (time frame: Preoperatively). 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 22 Nov 2023.