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
Researchers are evaluating a new robotic system designed to improve anterior cruciate ligament (ACL) reconstruction surgery. This advanced robot uses preoperative navigation to precisely place bone tunnels, aiming to enhance surgical accuracy and reduce complications. The study is a multi-center, randomized controlled trial led by Tsinghua University, focusing on the effectiveness of this domestic innovation in orthopedic surgery. The trial compares two surgical approaches for ACL reconstruction: one using robotic surgery guided by the preoperative navigation system, and the other using traditional arthroscopic surgery performed by experienced surgeons after the same navigation planning. Both methods use a standardized double-bundle reconstruction technique. Participants are randomly assigned to either the robotic or manual surgery group. Participants will undergo surgery and then be followed up with various assessments over two years. Researchers will measure the accuracy of bone tunnel placement one week after surgery and track knee function and pain using scores like the Lysholm score, IKDC, Tegner scale, and visual analog scale at multiple points up to 24 months. The study includes detailed evaluations of knee movement and stability to monitor recovery and outcomes throughout the follow-up period.
CONDITIONS
Brief 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
- Aged 18 to 80 years, any gender
- Diagnosed with anterior cruciate ligament (ACL) tear and no contraindications for implantation
- Mature skeleton
- Good compliance and willingness to participate in follow-up observations
You will not qualify if you...
- Previously participated in other clinical studies but did not meet primary endpoint within the required timeframe
- Known allergy to implanted materials
- Physically frail or unable to tolerate surgery due to systemic diseases
- Active infection in the knee joint or elsewhere
- Obesity with BMI greater than 35
- Severe diabetes with acute or chronic complications
- Pregnant or breastfeeding women
- Drug users or substance abusers
- Mentally incapacitated or unable to understand study requirements
- Poor compliance or unwillingness to follow postoperative therapy or rehabilitation
- Other conditions limiting participation, compliance, or study integrity
- Any other condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo anterior cruciate ligament reconstruction using either robotic or traditional manual surgery following preoperative navigation.
1 surgery visit (in-person)
Duration - Up to 24 months
Participants are assessed for bone tunnel footprint localization accuracy and recovery progress.
Visits at preoperative, 6 weeks, 3 months, 12 months, and 24 months post-surgery
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
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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