Anterior Cruciate Ligament RuptureNCT06961292
The Clinical Efficacy of Anterolateral Complex Augmentation in Patients With ACL Rupture Combined With Excessive Internal Tibial Rotation Subluxation: A Bidirectional Cohort Study
An observational study of Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- How many people
- 335 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients who underwent primary anterior cruciate ligament reconstruction at our institution and fulfilled the predefined inclusion and exclusion criteria.
Who may be able to join
- Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation [IRTS] > 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study.
Who cannot join
- Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on preoperative MRI. The study population will consist of patients with primary ACL rupture, and high-risk individuals will be identified based on the presence of EIRTS on preoperative knee MRI. The exposure group will undergo ACLR combined with ALC augmentation, while the control group will receive standard ACLR. Observational indicators will include all baseline patient characteristics and postoperative clinical outcomes.
Read the detailed description
Anterior cruciate ligament (ACL) rupture is one of the most common sports injuries in the field of sports medicine and significantly impairs athletic function. Autologous hamstring tendon single-bundle ACL reconstruction (ACLR) is the standard surgical technique for treating ACL rupture. Although most patients can return to sports postoperatively, a subset still experiences graft re-rupture, residual rotational instability of the knee, and other cases of reconstruction failure. Recent studies suggest that concomitant injury to the anterolateral complex (ALC) of the knee may be an important contributing factor. However, there is currently a lack of clinical evidence regarding the diagnosis of ALC injuries and the surgical indications for their treatment. Therefore, whether ALC should be augmented (diagnostic and surgical indications) in addition to routine ACLR, and how it should be augmented (surgical techniques), has become a key focus of current research.
This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on preoperative MRI. The study population will consist of patients with primary ACL rupture, and high-risk individuals will be identified based on the presence of EIRTS on preoperative knee MRI. The exposure group will undergo ACLR combined with ALC augmentation, while the control group will receive standard ACLR. Observational indicators will include all baseline patient characteristics and postoperative clinical outcomes.
The study includes two follow-up time points: 2 years and 5 years postoperatively. Follow-up will be conducted via outpatient visits and telephone interviews. Based on the follow-up outcomes, multivariate regression models will be used to analyze the association between exposure and clinical outcomes.
This cohort study aims to address treatment strategies for high-risk ACL rupture patients with preoperative EIRTS, thereby improving perioperative management and clinical decision-making in ACL injuries. It will provide important clinical evidence for establishing surgical indications for ALC augmentation and contribute to the development of long-term clinical prediction models for graft failure after ACLR. The findings will support innovation in ACL reconstruction techniques, optimization of perioperative strategies, reduction in postoperative graft failure rates, and improvement in return-to-sport rates. This study holds significant implications for advancing clinical research in the field of sports medicine.
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- anterior cruciate ligament, anterolateral complex, ateral extra-articular tenodesis, internal rotational tibial subluxation, tibiofemoral position, magnetic resonance imaging, bidirectional cohort study
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients who underwent primary anterior cruciate ligament reconstruction at our institution and met the following criteria: A. Inclusion Criteria: Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation [IRTS] > 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study. B. Exclusion Criteria: Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery. | |
| ALC augmentation group | Patients who underwent anterior cruciate ligament reconstruction combined with anterolateral complex augmentation using lateral extra-articular tenodesis (LET) and met the following criteria: A. Inclusion Criteria: Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation [IRTS] > 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study. B. Exclusion Criteria: Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Failure Rate
Graft failure was identified based on physical examination findings and postoperative MRI scans at the designated follow-up time points.
Measured: At 2 and 5 years postoperatively
Return to Pivoting Sports: Rate and Time
The rate and timing of return to pivoting sports were recorded at each follow-up time point.
Measured: At 2 and 5 years postoperatively
Secondary outcomes (4)
Patient-Reported Outcome Measures
Patient-reported outcome measures (PROMs) were collected at each follow-up time point using standardized questionnaires, including the Visual Analogue Scale for Pain (VAS), Tegner Activity Score, modified Lysholm Knee Scoring Scale, and the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form.
Measured: At 2 and 5 years postoperatively
Physical Examinations
Physical examinations were performed at each follow-up visit, including the anterior drawer test, Lachman test, pivot-shift test, and KT-2000 arthrometer assessment.
Measured: At 2 and 5 years postoperatively
Muscle Strength
Isokinetic muscle strength testing of the knee extensors and flexors was performed using the Biodex system.
Measured: At 2 and 5 years postoperatively
MRI Measurements
Postoperative MRI scans were scheduled for all patients to assess tibiofemoral position, osteoarthritis progression, and ACL graft signal intensity as indicators of graft healing, including anterior tibial subluxation (ATS), internal rotational tibial subluxation (IRTS), cartilage thickness and the signal-to-noise quotient (SNQ).
Measured: At 2 and 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (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 RuptureStudies 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
- Other
- Enrolment
- 335 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
- NCT06961292
- Sponsor's protocol ID
- M2024140; M2024141
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Anterolateral Complex Augmentation in Patients With ACL Rupture Combined With Excessive Internal Tibial Rotation Subluxation: A Bidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT06961292
- Acronym / sponsor ID
- M2024140; M2024141
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- anterior cruciate ligament, anterolateral complex, ateral extra-articular tenodesis, internal rotational tibial subluxation, tibiofemoral position, magnetic resonance imaging, bidirectional cohort study
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 335 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 May 2025 (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.
This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on preoperative MRI. The study population will consist of patients with primary ACL rupture, and high-risk individuals will be identified based on the presence of EIRTS on preoperative knee MRI. The exposure group will undergo ACLR combined with ALC augmentation, while the control group will receive standard ACLR. Observational indicators will include all baseline patient characteristics and postoperative clinical outcomes.
Detailed description
Anterior cruciate ligament (ACL) rupture is one of the most common sports injuries in the field of sports medicine and significantly impairs athletic function. Autologous hamstring tendon single-bundle ACL reconstruction (ACLR) is the standard surgical technique for treating ACL rupture. Although most patients can return to sports postoperatively, a subset still experiences graft re-rupture, residual rotational instability of the knee, and other cases of reconstruction failure. Recent studies suggest that concomitant injury to the anterolateral complex (ALC) of the knee may be an important contributing factor. However, there is currently a lack of clinical evidence regarding the diagnosis of ALC injuries and the surgical indications for their treatment. Therefore, whether ALC should be augmented (diagnostic and surgical indications) in addition to routine ACLR, and how it should be augmented (surgical techniques), has become a key focus of current research.
This project aims to establish a high-quality, large-scale, single-center bidirectional cohort study to evaluate the postoperative clinical efficacy of ACLR combined with ALC augmentation in a specific high-risk population-patients with ACL rupture exhibiting excessive internal tibial rotation subluxation (EIRTS) on preoperative MRI. The study population will consist of patients with primary ACL rupture, and high-risk individuals will be identified based on the presence of EIRTS on preoperative knee MRI. The exposure group will undergo ACLR combined with ALC augmentation, while the control group will receive standard ACLR. Observational indicators will include all baseline patient characteristics and postoperative clinical outcomes.
The study includes two follow-up time points: 2 years and 5 years postoperatively. Follow-up will be conducted via outpatient visits and telephone interviews. Based on the follow-up outcomes, multivariate regression models will be used to analyze the association between exposure and clinical outcomes.
This cohort study aims to address treatment strategies for high-risk ACL rupture patients with preoperative EIRTS, thereby improving perioperative management and clinical decision-making in ACL injuries. It will provide important clinical evidence for establishing surgical indications for ALC augmentation and contribute to the development of long-term clinical prediction models for graft failure after ACLR. The findings will support innovation in ACL reconstruction techniques, optimization of perioperative strategies, reduction in postoperative graft failure rates, and improvement in return-to-sport rates. This study holds significant implications for advancing clinical research in the field of sports medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Patients who underwent primary anterior cruciate ligament reconstruction at our institution and met the following criteria: A. Inclusion Criteria: Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation [IRTS] > 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study. B. Exclusion Criteria: Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery. |
| ALC augmentation group | – | –Patients who underwent anterior cruciate ligament reconstruction combined with anterolateral complex augmentation using lateral extra-articular tenodesis (LET) and met the following criteria: A. Inclusion Criteria: Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation [IRTS] > 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study. B. Exclusion Criteria: Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent primary anterior cruciate ligament reconstruction at our institution and fulfilled the predefined inclusion and exclusion criteria.
Key inclusion criteria (1 listed)
- Age ≥ 18 years; Primary unilateral ACL rupture; Preoperative knee MRI completed at our institution; Diagnosis of excessive internal tibial rotation subluxation (EIRTS) based on preoperative MRI measurements (i.e., internal rotation tibial subluxation [IRTS] > 5.8 mm); Patient has been informed of the study details and has provided written informed consent to participate in this cohort study.
Key exclusion criteria (1 listed)
- Concomitant injury to the medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL); History of contralateral knee injury; History of patellar dislocation; History of prior knee surgery.
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
Graft Failure Rate
Time frame: At 2 and 5 years postoperatively
Graft failure was identified based on physical examination findings and postoperative MRI scans at the designated follow-up time points.
Return to Pivoting Sports: Rate and Time
Time frame: At 2 and 5 years postoperatively
The rate and timing of return to pivoting sports were recorded at each follow-up time point.
4 secondary outcomes
Patient-Reported Outcome Measures
Time frame: At 2 and 5 years postoperatively
Physical Examinations
Time frame: At 2 and 5 years postoperatively
Muscle Strength
Time frame: At 2 and 5 years postoperatively
MRI Measurements
Time frame: At 2 and 5 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rupture, 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: enrolling by invitation, as of the sponsor's last update on 7 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Graft Failure Rate (time frame: At 2 and 5 years postoperatively). The study lists 2 primary outcomes in all. 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 7 May 2025.