Anterior Cruciate Ligament InjuriesNCT04944693
Relationship Between Anterior Tibial Subluxation and the Prognosis of Anterior Cruciate Ligament 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 improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Different ATS values.
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: anterior cruciate ligament-injured patients that had suffered from anterior cruciate ligament injury.
Inclusion Criteria: (1) Diagnosed anterior cruciate ligament injuries; (2) available preoperative MRI scans at our hospital.
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Exclusion Criteria: 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, and no access to the preoperative MRI scan at our hospital.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Reconstruction With 2-year Follow-up
To identify the improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images.
Read the detailed description
The value of preoperative anterior tibial subluxation (ATS) was used for the division of anterior cruciate ligament-injured patients in 2 groups. ATS was measured on pre- and postoperative MRI images. Patients were followed up 2 years after anterior cruciate ligament reconstruction, and patient reported outcomes (i.e. Lysholm score, etc.) were collected for further analysis.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Different ATS values.
- 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.
Different ATS values.Other
Observational, different ATS values were measured on MRI images and were regarded as "interventions" for different cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Anterior cruciate ligament-injured patients with excessive ATS Receives: Other: Different ATS values. | |
| Cohort 2 | Anterior cruciate ligament-injured patients with minimal ATS Receives: Other: Different ATS values. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients reported outcomes
(i.e. Lysholm score, etc.)
Measured: at least 1-year postoperatively
Secondary outcomes (1)
MRI images
Anterior tibial subluxation were measured on postoperative MRI images
Measured: at least 1-year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Mar 2021
- Primary completion1 Jul 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT04944693
- Sponsor's protocol ID
- M2020384
- Status last verified
- Nov 2023
- First submitted
- 27 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 Prospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Reconstruction With 2-year Follow-up
- ClinicalTrials.gov ID
- NCT04944693
- Acronym / sponsor ID
- M2020384
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- anterior tibial subluxation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 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 identify the improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images.
Detailed description
The value of preoperative anterior tibial subluxation (ATS) was used for the division of anterior cruciate ligament-injured patients in 2 groups. ATS was measured on pre- and postoperative MRI images. Patients were followed up 2 years after anterior cruciate ligament reconstruction, and patient reported outcomes (i.e. Lysholm score, etc.) were collected for further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Different ATS values.Anterior cruciate ligament-injured patients with excessive ATS |
| Cohort 2 | – | Other: Different ATS values.Anterior cruciate ligament-injured patients with minimal ATS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- anterior cruciate ligament-injured patients that had suffered from anterior cruciate ligament injury.
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 |
|---|---|---|
| Different ATS values.Observational, different ATS values were measured on MRI images and were regarded as "interventions" for different cohorts. | Other | Cohort 1, Cohort 2 |
Primary outcome
Patients reported outcomes
Time frame: at least 1-year postoperatively
(i.e. Lysholm score, etc.)
1 secondary outcome
MRI images
Time frame: at least 1-year postoperatively
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
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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.
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.
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?
Patients reported outcomes (time frame: at least 1-year postoperatively). 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.