Multicenter Clinical Study on Robotic-Assisted Surgical Management of Posterior Cruciate Ligament Tibial Avulsion Fractures

May 4, 2026 updated by: YujiakuoTHU, Beijing Tsinghua Chang Gung Hospital
The primary objective of this clinical trial is to evaluate the efficacy of robotic-assisted surgery in the management of posterior cruciate ligament (PCL) avulsion fractures involving the tibial insertion site of the cruciate ligament. Specifically, the study seeks to determine: (1) whether robotic-assisted surgery yields superior anatomical reduction accuracy-particularly in restoring the native position of the tibial avulsion fragment-compared with conventional open reduction and internal fixation (ORIF); and (2) whether such improved precision translates into enhanced long-term functional recovery of the knee joint.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients diagnosed with posterior cruciate ligament (PCL) tibial avulsion fractures-confirmed according to established radiographic and clinical diagnostic criteria-were prospectively enrolled from three geographically distinct regional medical centers. Prior to enrollment, all participants received comprehensive oral and written information detailing the study's objectives, methodology, potential risks and benefits, and the two comparative surgical interventions: robotic-assisted fixation and conventional open reduction and internal fixation (ORIF). Written informed consent was obtained from each participant following a mandatory reflection period and prior to randomization or any study-related procedures. All enrolled patients underwent standardized preoperative imaging, including anteroposterior and lateral radiographs of the knee, computed tomography (CT), and magnetic resonance imaging (MRI). Imaging interpretation was performed independently by two board-certified musculoskeletal radiologists blinded to group allocation; consensus adjudication resolved discrepancies. Radiological assessment confirmed diagnosis, classified fracture morphology using the Meyers-McKeever classification , and verified adherence to prespecified inclusion and exclusion criteria. Participants were then allocated in a 1:1 ratio to either the robotic-assisted surgery group (intervention group) or the ORIF group (control group) via centralized, stratified randomization-stratified by ageand fracture type . Baseline demographic, clinical, and functional assessments-including physical examination and validated patient-reported outcome measures (e.g., IKDC subjective score)-were completed preoperatively. All surgical procedures were performed by senior orthopedic surgeons with subspecialty expertise in knee trauma, either directly or under their immediate supervision, to ensure procedural fidelity and minimize interoperator variability. Primary and secondary outcomes were assessed at prespecified time points using objective, validated, and reproducible metrics. Radiographic evaluation of reduction accuracy entailed measurement of maximal sagittal displacement of the avulsed fragment on postoperative CT scans acquired within 72 ± 24 hours after surgery. The IKDC subjective score was collected at 24 weeks (±2 weeks) and 12 months (±1 month) postoperatively. Fracture union was determined radiologically using CT criteria and knee range of motion (ROM) was measured using a standard goniometer at 12 weeks (±1 week) and 24 weeks (±2 weeks). Intraoperative process metrics-including operative duration, intraoperative fluoroscopic exposure count, estimated blood loss (measured gravimetrically and volumetrically), and incidence of adverse events (e.g., surgical site infection, neurovascular injury, implant-related complications, or unplanned reoperation)-were systematically documented and compared between groups. Randomization was implemented using a computer-generated, permuted-block randomization sequence managed centrally and stratified as noted above. Statistical analyses adhered to a prespecified analysis plan: normality of continuous variables was assessed using the Shapiro-Wilk test; normally distributed data are presented as mean ± standard deviation and compared using independent-samples t-tests; non-normally distributed data are reported as median (interquartile range) and analyzed using the Mann-Whitney U test. Missing data were addressed via multiple imputation , followed by sensitivity analyses using complete-case and worst-case scenarios. Categorical variables are expressed as frequency (percentage) and compared using the chi-square test or Fisher's exact test, as appropriate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102218
        • Beijing Tsinghua Changgung Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years

    • Acute closed tibial avulsion fracture, with surgery performed within 3 weeks of injury ③ Radiographically confirmed Meyers-McKeever classification Type II or III fracture ④ Absence of absolute contraindications to surgical intervention ⑤ Provision of voluntary, written informed consent prior to enrollment

Exclusion Criteria:

  • Pathological fractures or complex ipsilateral injuries, including concomitant fractures at other anatomical sites.

    • Prior ipsilateral knee joint surgery. ③. Significant vascular or neurological compromise.

      • Acute meniscal tears, acute anterior cruciate ligament (ACL) ruptures, or acute injuries to the medial or lateral collateral ligaments.

        • Compromised local soft tissue integrity, including open fractures. ⑥. Withdrawal from the study or loss to follow-up despite having provided written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Experimental group
Perform surgical robot-assisted arthroscopic surgery
Procedure: Surgical robot-assisted arthroscopic surgery
Experimental group: Robot-assisted arthroscopic surgery
Other: Control group
Traditional posterior incision reduction and internal fixation surgery is performed
Procedure: Open reduction and internal fixation surgery
Control group: incisional reduction and internal fixation surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the quality of surgical reduction
Time Frame: 72 hours (±24 hours) after the surgery
In the CT scan images obtained approximately 72 hours (±24 hours) after the surgery, the maximum distance between the fracture fragments was measured on the sagittal plane.
72 hours (±24 hours) after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tsinghua Chang Gung Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yu Jia-kuo, Beijing Tsinghua Changgeng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26490-4-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The original dataset will be made available to the collaborating research team no later than 12 months following the completion of the clinical trial. Subsequently, de-identified data will be shared via a secure, encrypted transmission protocol. Any use of the data is strictly contingent upon prior written approval from the principal investigator and formal authorization by the institutional ethics review board, and shall be limited exclusively to peer-reviewed scientific research activities.

IPD Sharing Time Frame

The original data will be transferred to the collaborating research team within 12 months following the completion of the clinical trial and will remain accessible to them for a period of two years.

IPD Sharing Access Criteria

Within a defined timeframe following the conclusion of the trial, the collaborative research team may access the data repository and share de-identified data-including treatment records, follow-up assessments, and laboratory results-via secure data transmission methods. Any use of such data requires prior written agreement from the Principal Investigator and formal approval from the relevant Ethics Committee, and is strictly limited to scientific research purposes.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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