An observational study in Anterior Cruciate Ligament Rupture, sponsored by Peking University Third Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Peking University Third Hospital · Observational
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Among 33 studies in Anterior Cruciate Ligament Injuries by Peking University Third Hospital — 11 open to participants now, 12 under way, none of them phase 3. Anterior Cruciate Ligament Injuries · Peking University Third Hospital.
Among the 33 studies in Anterior Cruciate Ligament Injuries by Peking University Third Hospital, this one is the 2nd largest by planned enrollment of the 14 observational ones that give a count, is one of 3 that started in 2024, is one of 14 observational ones, reaches primary completion later than 6 of the 11 other live ones, and was the 27th registered.
625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.
Browse Anterior Cruciate Ligament Injuries studies →11 of the 33 studies in Anterior Cruciate Ligament Injuries by Peking University Third Hospital are open now, in 1 country. Recruiting first, the newest first:
Peking University Third Hospital · Sites in China
Ages 18–45 · Healthy volunteers
Peking University Third Hospital · Sites in China
Ages 18–45 · Healthy volunteers
Peking University Third Hospital · Sites in China
Ages 18–45
Peking University Third Hospital · Sites in China
Ages 18–40
Peking University Third Hospital · Sites in China
Ages 18–45
By country, each count listing its studies:
Of the 122 Anterior Cruciate Ligament Injuries studies recruiting now, 27 (22%) set no upper age limit and 92 (75%) stop at 75 or younger; 46 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 3 started in 2024.
This study's planned enrollment of 335 is above the median of 98 across 153 observational studies indexed under Anterior Cruciate Ligament Injuries.
Median enrollment 84 across the 19 interventional studies, 115 across the 14 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Peking University Third Hospital is the lead sponsor of 755 studies on the registry; 276 are open to participants now.
5 of the studies in Anterior Cruciate Ligament Injuries by Peking University Third Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06961292Peking University Third HospitalThe Clinical Efficacy of Anterolateral Complex Augmentation in Patients With ACL Rupture Combined With Excessive Internal Tibial Rotation Subluxation: A Bidirectional Cohort Study | 2026-12-31 |
| NCT07243860Peking University Third HospitalNeuromuscular Rehab for ACL Reconstruction: Knee Function & Brain Plasticity | 2027-03 |
| NCT07904949Peking University Third HospitalEffect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction | 2027-06-01 |
| NCT07833189Peking University Third HospitalMotor Imagery-Enhanced Rehabilitation Modulates Cortical Plasticity and Functional Recovery After ACL Reconstruction | 2027-08-10 |
| NCT07306221Peking University Third HospitalEffect of Visual-Guided Balance Training on Knee Motor Function and Biomechanical Characteristics After ACL Reconstruction | 2027-08-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 33 studies in Anterior Cruciate Ligament Injuries by Peking University Third Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Patients who underwent primary anterior cruciate ligament reconstruction at our institution and fulfilled the predefined inclusion and exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Graft Failure Rate
Graft failure was identified based on physical examination findings and postoperative MRI scans at the designated follow-up time points.
Time frame: 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.
Time frame: At 2 and 5 years postoperatively
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.
Time frame: 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.
Time frame: At 2 and 5 years postoperatively
Muscle Strength
Isokinetic muscle strength testing of the knee extensors and flexors was performed using the Biodex system.
Time frame: 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).
Time frame: At 2 and 5 years postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.
Of 73 non-industry observational studies under Anterior Cruciate Ligament Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 167. This study's planned 35 months is close to that.
Counting every sponsor, half of 82 studies reached it within 37 months; a quarter within 13 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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