Degenerative Disease, Fracture
Conditions
Keywords
early mobilisation, robot, spine, enhanced recovery
Brief summary
In this study, patients who underwent lumbar spine surgery in our hospital were included. A prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.
Interventions
PROCEDUREfirst ambulation at 4 hour after operation
Two groups were conducted for first ambulation at 4 or 24 hours aftër operation
Sponsors
Beijing Jishuitan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of degenerative diseases or spinal fracture * single level instrumentation sugery * sign informed consent
Exclusion criteria
* multilevel instrumentaion surgery * diagnosis of severe osteoperosis (BMD \< 60mg/cm3) by QCT * coagulant function abnormality * severe internal disease * not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | preoperative | Low back pain and leg pain is an important sign and a frequent patient complaint. The VAS pain scoring standard (scores from 0 to 10) was as following: 0 means painless; 1-3 means mild pain that the patient could endure; 4-6 means patient was in pain that could be endured and be able to sleep; and 7-10 means patient had intense pain and was unable to tolerate the pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Japanese Orthopedic Association | preoperative | The Japanese Orthopedic Association score was used to evaluate the neurological function of patients with lumbar degeneration and treatment effectiveness. The highest possible total score from categories for a normal person is 29 points. Therefore, treatment improvement rate = \[(post-treatment score - pre-treatment score) / (29 - pre-treatment score)\] × 100%, and ≥75% means excellent; 50%-74% means good; 25%-49% means fair; 0-24% means poor. |
| Oswestry Disability Index | preoperative | The Oswestry Disability Index is one of the principal condition-specific outcome measures used in the management of spinal disorders. Rounding the percentage to a whole number is suggested for convenience. So the final score may be summarized as: \[total score / (5 × number of questions answered)\] × 100%. It is suggested rounding the percentage to a whole number for convenience. We defined that 0-20% means mild; 21%-40% means moderate; 41%-60% means severe; 61%-80% means very severe；80%-100% means patients very exaggerated symptoms. |
Countries
China
Contacts
Primary ContactWei Tian, MD
Backup ContactWei Tian
Outcome results
None listed