Anterior Cruciate LigamentNCT07086417
Robot-Assisted Versus Conventional Arthroscopic ACL Reconstruction: A Prospective Comparative Study
A study testing Robot-Assisted Arthroscopic ACL Reconstruction and Conventional Arthroscopic ACL Reconstruction in people with Anterior Cruciate Ligament, run by Chunyan Jiang.
Trial summary
This study aims to evaluate the clinical efficacy and biomechanical accuracy of a newly developed robot-assisted system for anterior cruciate ligament (ACL) reconstruction. ACL injuries are among the most common sports-related injuries in active individuals and athletes, and reconstruction surgery is considered the… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anterior Cruciate Ligament
- What is being tested?
- Robot-Assisted Arthroscopic ACL Reconstruction and Conventional Arthroscopic ACL Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to Dec 2027
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age over 16 years old; Primary anterior cruciate ligament (ACL) rupture confirmed by physical examination and MRI; Surgery scheduled within 3 months of injury; Patients eligible for autograft ACL reconstruction using 8S-ST/G technique; Normal range of motion in the contralateral knee; Willingness to participate and sign informed consent.
Who cannot join
- Previous surgery on either knee; Multi-ligament injuries or complex injuries requiring additional procedures; History of rheumatologic or systemic inflammatory joint diseases; Moderate to severe osteoarthritis (Kellgren-Lawrence grade ≥ 2); Poor general health or contraindications to surgery; Refusal to participate or inability to follow up.
About this study
Official title: A Prospective Controlled Study on Robot-Assisted Versus Conventional Arthroscopic Anterior Cruciate Ligament Reconstruction
This study aims to evaluate the clinical efficacy and biomechanical accuracy of a newly developed robot-assisted system for anterior cruciate ligament (ACL) reconstruction. ACL injuries are among the most common sports-related injuries in active individuals and athletes, and reconstruction surgery is considered the gold standard for treatment. However, failure rates remain substantial-up to 10.3% in the general population and as high as 40% among high-demand patients, such as young athletes. One of the key technical factors contributing to graft failure is improper placement of the femoral and tibial bone tunnels during surgery, which affects graft isometry, kinematics, and long-term function.
This prospective, randomized, controlled clinical trial will include 120 adult patients with confirmed ACL rupture. Subjects will be randomly assigned to two groups: an experimental group undergoing robot-assisted arthroscopic ACL reconstruction, and a control group receiving traditional arthroscopic ACL reconstruction. The investigational robot system is a custom-designed platform that integrates three primary modules: (1) preoperative planning, (2) intraoperative surgical assistance, and (3) biomechanical evaluation. The robot is designed to support precise tunnel positioning using CT/MRI fusion, dynamic motion tracking during surgery, and post-placement assessment of graft trajectory, potential impingement, and mechanical stability.
Read more
Preoperative planning includes 3D reconstruction from CT and MRI imaging to identify optimal anatomical positions for the femoral and tibial tunnels. During surgery, the robot allows the surgeon to perform the procedure in a semi-active "cooperative control" mode, combining robotic precision with the surgeon's decision-making and dexterity. Unlike existing robotic platforms, this system enables limited patient limb movement and real-time position tracking, making it uniquely suited for arthroscopic procedures.
The primary endpoint of the study is anterior tibial translation at 2 years postoperatively, measured using the KT-1000 arthrometer to compare surgical and contralateral knees. Secondary endpoints include subjective knee function scores (Lysholm, Kujala, and Tegner), CT and MRI evaluation of tunnel placement and graft integration, and physical examination results. Follow-up will occur preoperatively and at 2 years postoperatively via in-person visits.
Sample size was calculated based on differences in Lysholm scores from prior navigation-assisted studies. With an alpha level of 0.05, a power of 0.90, and a 20% expected loss to follow-up, 60 patients will be enrolled in each group. Data will be analyzed using SPSS v22.0. Parametric and non-parametric tests will be applied as appropriate, including ANOVA, Bonferroni post-hoc comparisons, and Cochran's Q for repeated categorical variables. A p-value <0.05 will be considered statistically significant.
This study is conducted by the Department of Sports Medicine at Beijing Jishuitan Hospital, a leading orthopedic and trauma care center in China, affiliated with Capital Medical University. The project is supported by the Capital Clinical Special Diagnosis and Treatment Technology Research and Translational Application Program and involves collaboration with Beijing Tiansing Bomed Medical Devices Co., Ltd., which is responsible for the robotic platform development and maintenance.
Ethical approval has been obtained from the Institutional Review Board of Beijing Jishuitan Hospital. All patients will provide written informed consent before enrollment. The study complies with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and local regulations.
Expected outcomes of this study include evidence of improved tunnel placement accuracy, enhanced functional recovery, and potentially reduced failure rates with robot-assisted ACL reconstruction. If successful, this research may contribute to broader adoption of robotic technology in arthroscopic sports medicine surgery and support future innovations in orthopedic surgical robotics.
- Conditions
- Anterior Cruciate Ligament
- Being tested
- Robot-Assisted Arthroscopic ACL Reconstruction, Conventional Arthroscopic ACL Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Arthroscopic ACL ReconstructionProcedure or surgery
This intervention involves the use of a customized robotic surgical system to assist in arthroscopic anterior cruciate ligament (ACL) reconstruction. The system integrates preoperative planning with CT/MRI fusion imaging, intraoperative surgical guidance for femoral and tibial tunnel creation, and real-time biomechanical evaluation. The robot provides enhanced precision in tunnel positioning and graft placement compared to conventional techniques.
Conventional Arthroscopic ACL ReconstructionProcedure or surgery
This intervention uses standard arthroscopic techniques for ACL reconstruction without robotic assistance. Tunnel positions are determined manually using surgical landmarks and guides. Graft placement, tensioning, and isometry assessment are performed by the surgeon using conventional methods.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted ACL Reconstruction | Experimental | Participants in this group will undergo arthroscopic anterior cruciate ligament (ACL) reconstruction using a custom-designed robotic surgical system. The system includes preoperative planning, intraoperative guidance, and biomechanical evaluation modules. Tunnel positions are planned based on CT and MRI fusion images, and the robot assists the surgeon with precise femoral and tibial tunnel drilling. Biomechanical assessments such as graft isometry and impingement risk are evaluated intraoperatively. Receives: Procedure: Robot-Assisted Arthroscopic ACL Reconstruction |
| Conventional Arthroscopic ACL Reconstruction | Active comparator | Participants in this group will receive conventional arthroscopic ACL reconstruction. Femoral and tibial tunnels are created manually using standard guides and instrumentation. Graft placement and tensioning are performed according to traditional techniques, and isometry and impingement are assessed manually during surgery. Receives: Procedure: Conventional Arthroscopic ACL Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Tibial Translation Measured by KT-1000
Anterior tibial translation will be measured using the KT-1000 arthrometer to assess knee joint stability. The difference in anterior translation between the operated and contralateral knees will be recorded. This outcome is intended to evaluate the functional success of ACL reconstruction and the accuracy of tunnel positioning.
Measured: At 24 months post-operation
Secondary outcomes (3)
Lysholm Knee Score
Lysholm score will be used to assess knee function and stability. Patients will complete the questionnaire before surgery and at 24 months postoperatively. Scores range from 0 to 100, with higher scores indicating better function.
Measured: Baseline and 24 months post-operation
Kujala Anterior Knee Pain Score
The Kujala score evaluates anterior knee pain and function during activities such as walking, squatting, and climbing stairs. It will be administered preoperatively and 24 months after surgery. Higher scores indicate fewer symptoms.
Measured: Baseline and 24 months post-operation
MRI Evaluation of Graft Position and Integrity
MRI will be used to assess the position of the femoral and tibial tunnels and the integrity of the ACL graft. Imaging will be performed immediately after surgery and at 24 months postoperatively.
Measured: Immediate postoperative period and 24 months post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunyan Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- Star Sports Medicine Co., Ltd
- Responsible party
- Sponsor-investigator, Chunyan Jiang, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086417
- Sponsor's protocol ID
- Z221100007422004
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Controlled Study on Robot-Assisted Versus Conventional Arthroscopic Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07086417
- Acronym / sponsor ID
- Z221100007422004
- Conditions
- Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chunyan JiangUniversity, hospital or other
- Collaborators
- Star Sports Medicine Co., Ltd
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Jul 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 study aims to evaluate the clinical efficacy and biomechanical accuracy of a newly developed robot-assisted system for anterior cruciate ligament (ACL) reconstruction. ACL injuries are among the most common sports-related injuries in active individuals and athletes, and reconstruction surgery is considered the gold standard for treatment. However, failure rates remain substantial-up to 10.3% in the general population and as high as 40% among high-demand patients, such as young athletes. One of the key technical factors contributing to graft failure is improper placement of the femoral and tibial bone tunnels during surgery, which affects graft isometry, kinematics, and long-term function.
This prospective, randomized, controlled clinical trial will include 120 adult patients with confirmed ACL rupture. Subjects will be randomly assigned to two groups: an experimental group undergoing robot-assisted arthroscopic ACL reconstruction, and a control group receiving traditional arthroscopic ACL reconstruction. The investigational robot system is a custom-designed platform that integrates three primary modules: (1) preoperative planning, (2) intraoperative surgical assistance, and (3) biomechanical evaluation. The robot is designed to support precise tunnel positioning using CT/MRI fusion, dynamic motion tracking during surgery, and post-placement assessment of graft trajectory, potential impingement, and mechanical stability.
Preoperative planning includes 3D reconstruction from CT and MRI imaging to identify optimal anatomical positions for the femoral and tibial tunnels. During surgery, the robot allows the surgeon to perform the procedure in a semi-active "cooperative control" mode, combining robotic precision with the surgeon's decision-making and dexterity. Unlike existing robotic platforms, this system enables limited patient limb movement and real-time position tracking, making it uniquely suited for arthroscopic procedures.
The primary endpoint of the study is anterior tibial translation at 2 years postoperatively, measured using the KT-1000 arthrometer to compare surgical and contralateral knees. Secondary endpoints include subjective knee function scores (Lysholm, Kujala, and Tegner), CT and MRI evaluation of tunnel placement and graft integration, and physical examination results. Follow-up will occur preoperatively and at 2 years postoperatively via in-person visits.
Sample size was calculated based on differences in Lysholm scores from prior navigation-assisted studies. With an alpha level of 0.05, a power of 0.90, and a 20% expected loss to follow-up, 60 patients will be enrolled in each group. Data will be analyzed using SPSS v22.0. Parametric and non-parametric tests will be applied as appropriate, including ANOVA, Bonferroni post-hoc comparisons, and Cochran's Q for repeated categorical variables. A p-value <0.05 will be considered statistically significant.
This study is conducted by the Department of Sports Medicine at Beijing Jishuitan Hospital, a leading orthopedic and trauma care center in China, affiliated with Capital Medical University. The project is supported by the Capital Clinical Special Diagnosis and Treatment Technology Research and Translational Application Program and involves collaboration with Beijing Tiansing Bomed Medical Devices Co., Ltd., which is responsible for the robotic platform development and maintenance.
Ethical approval has been obtained from the Institutional Review Board of Beijing Jishuitan Hospital. All patients will provide written informed consent before enrollment. The study complies with the Declaration of Helsinki, Good Clinical Practice (GCP) guidelines, and local regulations.
Expected outcomes of this study include evidence of improved tunnel placement accuracy, enhanced functional recovery, and potentially reduced failure rates with robot-assisted ACL reconstruction. If successful, this research may contribute to broader adoption of robotic technology in arthroscopic sports medicine surgery and support future innovations in orthopedic surgical robotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted ACL Reconstruction | Experimental | Procedure: Robot-Assisted Arthroscopic ACL ReconstructionParticipants in this group will undergo arthroscopic anterior cruciate ligament (ACL) reconstruction using a custom-designed robotic surgical system. The system includes preoperative planning, intraoperative guidance, and biomechanical evaluation modules. Tunnel positions are planned based on CT and MRI fusion images, and the robot assists the surgeon with precise femoral and tibial tunnel drilling. Biomechanical assessments such as graft isometry and impingement risk are evaluated intraoperatively. |
| Conventional Arthroscopic ACL Reconstruction | Active comparator | Procedure: Conventional Arthroscopic ACL ReconstructionParticipants in this group will receive conventional arthroscopic ACL reconstruction. Femoral and tibial tunnels are created manually using standard guides and instrumentation. Graft placement and tensioning are performed according to traditional techniques, and isometry and impingement are assessed manually during surgery. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age over 16 years old; Primary anterior cruciate ligament (ACL) rupture confirmed by physical examination and MRI; Surgery scheduled within 3 months of injury; Patients eligible for autograft ACL reconstruction using 8S-ST/G technique; Normal range of motion in the contralateral knee; Willingness to participate and sign informed consent.
Key exclusion criteria (1 listed)
- Previous surgery on either knee; Multi-ligament injuries or complex injuries requiring additional procedures; History of rheumatologic or systemic inflammatory joint diseases; Moderate to severe osteoarthritis (Kellgren-Lawrence grade ≥ 2); Poor general health or contraindications to surgery; Refusal to participate or inability to follow up.
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 |
|---|---|---|
| Robot-Assisted Arthroscopic ACL ReconstructionThis intervention involves the use of a customized robotic surgical system to assist in arthroscopic anterior cruciate ligament (ACL) reconstruction. The system integrates preoperative planning with CT/MRI fusion imaging, intraoperative surgical guidance for femoral and tibial tunnel creation, and real-time biomechanical evaluation. The robot provides enhanced precision in tunnel positioning and graft placement compared to conventional techniques. | Procedure or surgery | Robot-Assisted ACL Reconstruction |
| Conventional Arthroscopic ACL ReconstructionThis intervention uses standard arthroscopic techniques for ACL reconstruction without robotic assistance. Tunnel positions are determined manually using surgical landmarks and guides. Graft placement, tensioning, and isometry assessment are performed by the surgeon using conventional methods. | Procedure or surgery | Conventional Arthroscopic ACL Reconstruction |
Primary outcome
Anterior Tibial Translation Measured by KT-1000
Time frame: At 24 months post-operation
Anterior tibial translation will be measured using the KT-1000 arthrometer to assess knee joint stability. The difference in anterior translation between the operated and contralateral knees will be recorded. This outcome is intended to evaluate the functional success of ACL reconstruction and the accuracy of tunnel positioning.
3 secondary outcomes
Lysholm Knee Score
Time frame: Baseline and 24 months post-operation
Kujala Anterior Knee Pain Score
Time frame: Baseline and 24 months post-operation
MRI Evaluation of Graft Position and Integrity
Time frame: Immediate postoperative period and 24 months post-operation
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 25 Jul 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Arthroscopic ACL Reconstruction and Conventional Arthroscopic ACL Reconstruction in people with Anterior Cruciate Ligament, run by Chunyan Jiang.
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: opening soon, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Anterior Tibial Translation Measured by KT-1000 (time frame: At 24 months post-operation). 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 25 Jul 2025.