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Anterior Cruciate Ligament RuptureNCT06858930

Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction

A study testing ACL footprint localization after preoperative navigation executed by robotic arm and ACL footprint localization after preoperative navigation executed by rmanual execution in people with Anterior Cruciate Ligament Rupture, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The ACL surgery robot features a preoperative navigation system that enhances the precision of bone tunnel placement. As the first dual-bundle reconstruction surgical robot developed in China, it integrates advanced technology to ensure accurate anatomical alignment. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anterior Cruciate Ligament Rupture
What is being tested?
ACL footprint localization after preoperative navigation executed by robotic arm and ACL footprint localization after preoperative navigation executed by rmanual execution
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteChina
Study dates
24 Jan 2025to 24 Jan 2029
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Preoperatively, the participant or guardian is willing and able to sign the informed consent form;
  • Patients aged 18 to 80 years (inclusive of 18 and 80 years), regardless of gender;
  • Patients who meet the diagnostic criteria for anterior cruciate ligament (ACL) tear and have no contraindications for implantation;
  • Patients with mature skeletons;
  • Good compliance and willingness and ability to participate in follow-up observations as required.

Who cannot join

  • (1) Participants who have previously participated in other clinical studies of drugs, biological agents, or medical devices but did not meet the primary study endpoint within the specified timeframe; (2) Patients with a known allergy to one or more implanted materials; (3) Patients who are physically frail or unable to tolerate surgery due to other systemic diseases; (4) Presence of active infectious lesions in the knee joint or other parts of the body; (5) Obesity with a BMI > 35; (6) Patients with severe diabetes (acute complications of diabetes, preoperative random blood glucose ≥ 16.7 mmol/L with or without altered consciousness, such as diabetic ketoacidosis, suspected diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis; chronic complications of diabetes leading to severe target organ damage requiring urgent treatment, such as acute cardiovascular and cerebrovascular diseases, renal insufficiency, severe vision loss due to retinal disease, intermittent claudication and ischemic symptoms due to peripheral vascular disease, diabetic foot); (7) Women who are pregnant or breastfeeding; (8) Drug users and substance abusers; (9) Patients who are mentally incapacitated or unable to understand the requirements for participating in the study, making cooperation difficult; (10) Those expected to have poor compliance, unwilling or unable to follow postoperative therapy and/or rehabilitation program instructions; (11) Other comorbid conditions that limit participation in the study, hinder compliance with follow-up, or affect the scientific integrity of the study; (12) Other conditions judged by the investigator to be unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiakuo Yu, Tenured professor at Tsinghua contact

+86 13331031448

yujiakuo@126.com

China1 site, 1 recruiting
  • Beijing Tsinghua Chang Gung Hospital.

    Beijing, Beijing Municipality, 10000

    Recruiting

Other trials in China

About this study

The ACL surgery robot features a preoperative navigation system that enhances the precision of bone tunnel placement. As the first dual-bundle reconstruction surgical robot developed in China, it integrates advanced technology to ensure accurate anatomical alignment. This multi-center study aims to evaluate the robot's effectiveness in improving surgical outcomes and reducing complications, demonstrating the potential of domestic innovations in orthopedic surgery. With its high accuracy in locating bone tunnel footprints, this robot represents a significant advancement in ACL reconstruction techniques.

The trial is designed as a randomized controlled trial (RCT) led by a prospective randomized cohort. The study is initiated by Tsinghua University's long-term professor, Yu Jiakuo, and the product has received China's Class III clinical registration certificate.

Being tested
ACL footprint localization after preoperative navigation executed by robotic arm, ACL footprint localization after preoperative navigation executed by rmanual execution
Keywords
Anterior cruciate ligament rupture, ACL reconstruction, Surgical Navigation, Robotic Surgery, Bone Tunnel Footprint Localization Accuracy
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.

  • ACL footprint localization after preoperative navigation executed by robotic armProcedure or surgery

    Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.

  • ACL footprint localization after preoperative navigation executed by rmanual executionProcedure or surgery

    Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.

Study groups in NCT06858930
Study groupRoleWhat they receive
Robotic Surgery after Preoperative NavigationExperimentalAfter planning the preoperative bone tunnel using the navigation system from Naton Robotics, robotic surgery will be performed on the day of the operation.
Receives: Procedure: ACL footprint localization after preoperative navigation executed by robotic arm
Traditional Arthroscopic Surgery after Preoperative NavigationActive comparatorAfter planning the preoperative bone tunnel using the navigation system from Naton Robotics, a senior physician will perform traditional arthroscopic surgery on the day of the operation.
Receives: Procedure: ACL footprint localization after preoperative navigation executed by rmanual execution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of Bone Tunnel Footprint Localization Accuracy

    The localization of bone tunnels is evaluated by comparing the deviation of each tunnel's position from its preoperative planned position at one week post-surgery (hereinafter referred to as "bone tunnel deviation value"). At one week post-surgery, each participant undergoes CT three-dimensional imaging of the knee joint on the surgical side, and the bone tunnel positions of the reconstructed ACL on the femur and tibia are measured. The measurement of the femoral tunnel uses the Bernard and Hertel method, measuring the ratio of the center point of the femoral tunnel relative to the Blumensaat line in terms of the horizontal length and height of the lateral femoral condyle. The measurement of the tibial tunnel uses the Stäubli and Rauschning method, measuring the ratio of the center point of the tibial tunnel in relation to the anterior-posterior and medial-lateral dimensions of the tibial plateau. Each research center has designated researchers review the images, and each tunnel cente

    Measured: One week post-surgery

Secondary outcomes (6)
  1. Lysholm score

    At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers assess the Lysholm score of the affected knee joint for each participant.The Lysholm knee score, published in 1982 and revised in 1985, has a total score of 100 points. This scale primarily evaluates daily living and athletic function, scoring eight aspects: limping, pain, support, locking, swelling, instability, stair climbing, and squatting. Among these, pain and instability together account for 50 points. The highest score is 100 points, while the lowest is 0 points.

    Measured: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

  2. Relative Anterior Translation of the Tibia

    At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers measure the anterior translation distance of the tibia for both the affected and healthy knee joints of the participants. Each side is measured three times, and the average of these three measurements is taken as the final measurement value for the anterior translation distance of the tibia. The relative anterior translation distance is calculated as the affected tibial anterior translation distance minus the healthy tibial anterior translation distance. Measurements are performed using the Kneelaxity arthrometer.

    Kneelaxity arthrometer is a device used to assess knee joint stability by measuring the anterior translation of the tibia relative to the femur, providing objective data on knee laxity and aiding in the evaluation of knee injuries and surgical outcomes.

    Measured: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

  3. Knee Flexion and Extension Angle (Range of Motion)

    At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers use a goniometer to measure the flexion and hyperextension angles of the affected knee joint. Each angle is measured three times, and the average of these three measurements is taken as the final measurement value for each angle.

    Measured: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

  4. International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)

    At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, researchers assess the IKDC score for the affected knee joint of each participant. Responses to each item are scored using an ordinal scale, where the answer representing the lowest functional level or highest symptom level receives 0 points. For example, the first item relates to performing the highest level of activity without significant pain; if the response is "I cannot perform any of the above activities due to knee pain," it receives 0 points; if the response is "very vigorous activities, such as jumping or rotating in basketball or soccer games," it also receives 0 points. The second item pertains to the frequency of pain over the past four weeks, where "constant pain" receives 0 points and "no episodes" receives 10 points.

    The scoring method for the IKDC subjective knee function evaluation form involves summing the scores of the above items (the 10th item, "What was your knee function b

    Measured: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

  5. Tegner Knee Activity Scale

    The researchers assess the Tegner Knee Activity Scale for the affected knee joint of each participant at preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

    Tegner Knee Activity Scale is a scoring system used to evaluate knee function and activity level. The scale scores patients based on the intensity of various activities they have been able to perform over a specific period. The score ranges from 0 to 10, where 0 indicates the inability to perform any activities, and 10 indicates the ability to engage in high-intensity sports, such as competitive-level activities. The Tegner score helps clinicians understand the functional status of the patient's knee and its impact on daily life and sports activities.

    Measured: *At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

  6. Visual Analog Scale (VAS) Score

    The researchers assess the VAS pain score for each participant at preoperative, 1 week postoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months, and calculate the improvement rate of the VAS score at 1 week, 6 weeks, and 3 months postoperative.

    Visual Analog Scale (VAS) is a subjective scale used to assess pain intensity. The VAS typically consists of a horizontal or vertical line, usually 10 centimeters long, with endpoints labeled "no pain" (0 points) and "worst imaginable pain" (10 points). Patients score their pain intensity by marking a point on this line.

    Measured: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2025
  2. Study start24 Jan 2025
  3. Primary completion24 Jan 2025
  4. Study completion24 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Robotic Surgery after Preoperative Navigation vs Traditional Arthroscopic Surgery after Preoperative Navigation
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06858930
Sponsor's protocol ID
24751-0-02
Status last verified
Feb 2025
First submitted
28 Feb 2025
Last updated
5 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Results of the Excel table for primary and secondary indicators, with personal information of each patient concealed.

Questions about this trial

What is this clinical trial studying?

A study testing ACL footprint localization after preoperative navigation executed by robotic arm and ACL footprint localization after preoperative navigation executed by rmanual execution in people with Anterior Cruciate Ligament Rupture, run by Beijing Tsinghua Chang Gung 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 5 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: looking for participants now, as of the sponsor's last update on 5 Mar 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?

Contact Jiakuo Yu, Tenured professor at Tsinghua (+86 13331031448, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Bone Tunnel Footprint Localization Accuracy (time frame: One week post-surgery). 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 5 Mar 2025.

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