Safety Clinical Trial
Official title:
Clinical Trial for the Application of Robotic System in Spinal Surgery: a Randomized Controlled Study
This randomized controlled study was designed to evaluate the accuracy, safety and clinical outcomes of the robot assisted spinal surgery.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Spinal disease required for screw fixation;signed the inform consent Exclusion Criteria: - Patients with severe osteoporosis; patients with old fractures; patients with pedicle deformity; patients with severe systemic diseases; patients with coagulation disorders; patients who are considered unsuitable for this trail by the clinician. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Jishuitan Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Jishuitan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Screw guide wire adjustment times | The adjustment times of screw guide wire during surgery | During surgery | |
Primary | Screw adjustment times | The adjustment times of screw during surgery | During surgery | |
Primary | Deviation of screw | The deviation between the actual position of screw and the preoperative designed position | Up to 12 weeks | |
Primary | Perforation rate of screw | Rate of screws breaching out pedicles on postoperative CT image | Up to 12 weeks | |
Secondary | Operation time | Operation time | During surgery | |
Secondary | Blood loss | Blood loss during surgery | During surgery | |
Secondary | Complications | Complications after surgery | Up to 4 weeks | |
Secondary | Hospital stay after surgery | Hospital stay after surgery | Up to 4 weeks | |
Secondary | Hospitalization costs | Hospitalization costs | Up to 4 weeks | |
Secondary | Visual Analogue Scale | Visual Analogue Scale | 3 days before surgery | |
Secondary | Visual Analogue Scale | Visual Analogue Scale | 3 days after surgery | |
Secondary | Neck Disability Index | Neck Disability Index | 3 days before surgery | |
Secondary | Neck Disability Index | Neck Disability Index | 3 days after surgery | |
Secondary | Oswestry Disability Index | Oswestry Disability Index | 3 days before surgery | |
Secondary | Oswestry Disability Index | Oswestry Disability Index | 3 days after surgery | |
Secondary | modified Japanese orthopaedic association score | modified Japanese orthopaedic association score | 3 days before surgery | |
Secondary | modified Japanese orthopaedic association score | modified Japanese orthopaedic association score | 3 days after surgery |
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