Clinical trial NCT06858930: Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction
Official title: Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior cruciate ligament rupture
ACL reconstruction
Surgical Navigation
Robotic Surgery
Bone Tunnel Footprint Localization Accuracy
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
Collaborators: name: Nanyang Orthopedic Hospital
name: Weifang Yidu Central Hospital
First posted: 2025-03-05
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Robotic Surgery after Preoperative Navigation vs Traditional Arthroscopic Surgery after Preoperative Navigation
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* (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.

Primary outcomes:
measure: Evaluation of Bone Tunnel Footprint Localization Accuracy
timeFrame: One week post-surgery
Secondary outcomes:
measure: Lysholm score
timeFrame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
measure: Relative Anterior Translation of the Tibia
timeFrame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
measure: Knee Flexion and Extension Angle (Range of Motion)
timeFrame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
measure: International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)
timeFrame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
measure: Tegner Knee Activity Scale
timeFrame: *At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
measure: Visual Analog Scale (VAS) Score
timeFrame: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital.
state: Beijing
Study officials:
References: