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Robotic-Assisted Midline Lumbar Interbody Fusion for the Treatment of Degenerative Lumbar Spinal Stenosis: A Prospective, Randomized, Controlled, Non-Inferiority Study

A Clinical Study on the Enhanced Recovery after Surgery in the Treatment of Lumbar Stenosis in the Elderly Population with Robot-Assisted Midline Lumbar Interbody Fusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095896
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative lumbar spinal stenosis

Interventions

Trial group:Robotic-assisted midline lumbar interbody fusion with cortical bone trajectory screw fixation
Control group:Robotic-assisted lumbar posterior interbody fusion with pedicle screw fixation

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 60-80 years old; 2. Diagnosed with degenerative lumbar spinal stenosis; 3. Ineffective after at least 3 months of regular conservative treatment.

Exclusion criteria

Exclusion criteria: 1. History of previous lumbar spine surgery; 2. Combined with severe spinal deformity, spinal tumor, infection, inflammatory disease; 3. Have serious heart, lung, liver, kidney and other comorbidities, or malignant diseases, or are expected to be physically unable to tolerate surgery; 4. Long-term use of hormone drugs; 5. Suffering from mental illness; 6. Refusal to sign informed consent.

Design outcomes

Primary

MeasureTime frame
Oswestry disability index;—

Secondary

MeasureTime frame
Visual analogue scale;Japanese Orthopaedic Association score;Length of procedure;Length of surgical incision;Intraoperative blood loss;Intraoperative fluoroscopy radiation dose;Quantity of 24h postoperative drainage;Length of stay after operation;Accuracy of screw placement;Facet joint violation rate;Lumbar spine stability;Interbody fusion rate;ERAS evaluation;—

Countries

China

Contacts

Public ContactLixiang Ding

Beijing Shijitan Hospital, Capital Medical University

dinglx@bjsjth.cn+86 139 1091 2188

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026