Status:
UNKNOWN
Navigation and Positioning System for Orthopedic Surgery
Lead Sponsor:
Nanjing Tuodao Medical Technology Co., Ltd
Conditions:
Pedicle Screw Fixation of Spine
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This clinical trial is a prospective, multicenter, non inferiority, randomized controlled trial. We plan to include 112 subjects in China and randomly assign them to the experimental group and the con...
Eligibility Criteria
Inclusion
- They were 18-75 years old;
- From thoracic vertebrae to lumbar vertebrae, pedicle screw fixation is needed;
- Signed informed consent, willing to receive treatment and follow-up according to the requirements of the trial protocol.
Exclusion
- Patients with pedicle deformity.
- Patients with severe osteoporosis.
- Patients with spinal tumor or tuberculosis.
- Patients with abnormal liver function (alanine aminotransferase, aspartate aminotransferase values \> 3 times of the upper limit of the normal range) and abnormal renal function (creatinine values \> 3 times of the upper limit of the normal range).
- Patients with abnormal coagulation function (prothrombin time, activated partial thromboplastin time \> 1.5 times of the upper limit of normal range).
- Pregnant or lactating women.
- Patients with mental disorders.
- The investigators evaluated patients who were not suitable for pedicle screw fixation.
- Patients who are participating in clinical trials of any other device or drug.
- Poor compliance, difficult to cooperate with patients who complete treatment and follow-up.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 28 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04883580
Start Date
May 28 2021
End Date
May 28 2022
Last Update
May 12 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.