lumbar disc herniation
Conditions
Interventions
experimental group:spinal robot-assisted mis-TLIF surgery
control group:traditional mis-TLIF surgery
Sponsors
Shanghai Changzheng Hospital, Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1) Demographic characteristics: 18 years old or older, up to 79 years old, gender is not limited. (2) History of lumbar disc herniation for more than 6-12 weeks, ineffective after systematic conservative treatment; or symptoms worsened or relapsed during conservative treatment; (3) Severe pain due to lumbar disc herniation (VAS score > 5), or patients are in forced positions that affect their work or daily life; (4) Lumbar disc herniation causing single nerve root paralysis or cauda equina paralysis, manifested by muscle paralysis or rectal and bladder symptoms.
Exclusion criteria
Exclusion criteria: (1) Spinal Anatomy-related: The vertebral segment that is evaluated is likely to have existing or previous fractures/injuries in the vertebral body or pedicle; the same location has undergone previous trauma or surgery; there is spontaneous multiple compression fractures of the spine; there is deformans osteitis (Pegetic bone disease), osteomalacia, or other metabolic bone diseases; the segment of the spine that is to undergo surgical treatment has developmental scoliosis or malformation of the vertebral body and pedicle. (2) General Physical Status-related: There are conditions such as heart, lung, liver, and kidney dysfunction or other serious diseases (e.g, osteomyelitis, systemic infection, severe bleeding disorder, active intravascular coagulation, severe cardiovascular disease, myocardial infarction within 6 months before enrollment, cerebral infarction within 6 months before enrollment, severe mental illness); Pregnant or lactating women; unable to tolerate general anesthesia surgery; (3) Other: Participating in another drug or medical device clinical trial within 3 months before enrollment; The investigator expects that the positioning for the study will not meet the requirements for surgery; The preoperative diagnosis cannot be accurately determined through medical imaging; Other situations that are judged by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| delta Oswestry disability index(?ODI); | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score;CK level;Myoglobin;Psoas muscle atrophy;complication of wound;massive haemorrhage;pulmonary infection;urinary infection;Mean operation time;Intraoperative blood transfusion volume;X-ray dose;the length of wound;peroperative bleeding;quality of life;Independent walking time after surgery;length of stay;Postoperative drainage;Good placement rate of nails;Postoperative fusion rate;Reoperation rate;facet joint violation;The change in intervertebral disc height of adjacent segments proximal to the target segment.; | — |
Countries
China
Contacts
Public ContactWei Xu
Shanghai Changzheng Hospital, Second Military Medical University
Outcome results
None listed