Actively Recruiting
Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2025-03-05
76
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
B
Beijing Tsinghua Chang Gung Hospital
Lead Sponsor
N
Nanyang Orthopedic Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign the informed consent form before surgery
- Aged 18 to 80 years, any gender
- Diagnosed with anterior cruciate ligament (ACL) tear without contraindications for implantation
- Have mature skeletons
- Able and willing to comply with follow-up visits and observations
You will not qualify if you...
- Previously participated in other clinical studies without meeting primary endpoints as required
- Known allergy to any implanted materials
- Physically frail or unable to tolerate surgery due to systemic diseases
- Active infectious lesions in the knee or elsewhere
- Obesity with a BMI greater than 35
- Severe diabetes with acute or chronic complications requiring urgent treatment
- Pregnant or breastfeeding women
- Drug users or substance abusers
- Mentally incapacitated or unable to understand study requirements
- Expected poor compliance or unwillingness to follow postoperative therapy or rehabilitation
- Other medical conditions limiting study participation or affecting scientific integrity
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Chang Gung Hospital.
Beijing, Beijing Municipality, China, 10000
Actively Recruiting
Research Team
J
Jiakuo Yu, Tenured professor at Tsinghua
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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