A Prospective Controlled Study on Robot-Assisted Versus Conventional Arthroscopic Anterior Cruciate Ligament Reconstruction
Phase: NA
Conditions: Anterior Cruciate Ligament
Sponsor: Chunyan Jiang

Official Title:
Robot-Assisted Arthroscopic Anterior Cruciate Ligament Reconstruction: A Prospective
Randomized Controlled Trial
NCT Number:
[To be filled after registration]
Document Date:
March 25, 2025

Study Design and Methods
1. Type of Study
This is an interventional trial.
2. Study Hypothesis
This study adopts a randomized controlled trial design. The experimental group will receive
robot-assisted ACL reconstruction, while the control group will undergo conventional ACL
reconstruction. The hypothesis is that both groups will achieve similar clinical outcomes;
however, the femoral tunnel position in the experimental group will more closely
approximate the anatomical point as measured by the Bernard quadrant method, and the
graft isometry will be superior.
3. Study Protocol
Experimental Group: Patients will undergo ACL reconstruction with a dedicated robotic
system. Preoperative CT and MRI will be used to plan femoral and tibial tunnel positions.
The robot will assist in assessing the feasibility of the planned trajectory, predict graft
isometry and impingement risks, aid in tunnel drilling, and perform quantitative axial shift
testing.
Control Group: Patients will receive standard arthroscopic ACL reconstruction using
manual techniques. Femoral tunnels will be created with offset guides, and tibial tunnels
with traditional ACL aiming devices. Graft fixation and assessments will be performed
manually.
4. Study Population
Inclusion Criteria: Patients aged >14 years with ACL rupture, closed growth plates, full
cognitive capacity, signed informed consent.
Exclusion Criteria: Combined ligament injuries, bilateral ACL injuries, poor skin/soft tissue
condition, active infection, or systemic diseases requiring priority treatment.

Withdrawal Criteria: Patient-requested withdrawal, study termination, unacceptable risk as
judged by the investigator, or other circumstances requiring withdrawal.
Elimination Criteria: Subjects not meeting eligibility criteria, or who withdraw early, or
exhibit poor compliance. Case elimination is discussed and confirmed prior to data analysis
by the PI and statistician.
5. Outcome Measures and Follow-Up Plan
Primary Outcome: Side-to-side difference measured by KT-1000 at 2 years post-op.
Secondary Outcomes: Lysholm, Kujala, and Tegner scores preoperatively and at 2 years; CT
and MRI imaging at discharge and 2 years; physical examinations at the same time points.
Follow-Up Schedule: At baseline and 2 years post-op, conducted face-to-face.
6. Sample Size Calculation
Based on Lysholm scores from prior navigation-assisted studies, the experimental group is
expected to score 87.6±16.0 and control 77.4±15.0. Using α=0.05, β=0.1, and a 1:1 allocation
ratio, each group requires 49 patients. Accounting for 20% loss to follow-up, 60 patients per
group will be enrolled.
7. Statistical Methods
Software: SPSS 22.0.

Continuous Variables: Normal distribution: mean±SD, analyzed using ANOVA with
Bonferroni post-hoc if variances are equal, or Dunnett T3 if not. Non-normal data: median
and IQR, analyzed via Kruskal-Wallis test.
Categorical Variables: Chi-square or Fisher’s exact test.
Repeated Measures: Paired t-test or repeated measures ANOVA for continuous variables;
Cochran’s Q test for categorical variables. P<0.05 is considered significant.
8. Experimental Procedures
Preoperative Planning Module: Enables surgeon-robot collaboration via 3D CT/MRI
reconstruction. Tunnels are planned using Bernard quadrant method, IDEAL positioning,
anatomical landmarks, and contralateral MRI as reference. The module predicts graft path
and impingement risk.
Intraoperative Module (Motion Tracking): Integrates surgeon guidance with robotic
precision. The robot acts as an extension of the surgeon’s arm, enabling precise tunnel
drilling without changing habitual surgical behavior. The robot tracks limb motion and
adjusts accordingly.
Biomechanical Evaluation: Quantifies axial shift via a 6-degree-of-freedom optical tracking
system. This approach represents a novel, domestically developed technique with leading
international potential.

9. Data Management and Quality Assurance
Standardized training for research staff on eligibility criteria.
Implementation of standardized workflow and staff training.
Independent blinded evaluators trained at study initiation.
Dedicated personnel assigned to verify the accuracy and completeness of study data.