UBE spine surgery exploration

Comparing the outcomes between groups of patients with spine disease treated with unilateral biportal endoscopic decompression technique and other surgeries

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85840831

Enrollment

300

Registered

2023-01-30

Start date

2021-01-19

Completion date

Unknown

Last updated

2023-02-13

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

Conditions

Treatment of spine disease with unilateral biportal endoscopic (UBE) decompression technique and other classic surgeries Surgery

Interventions

The study will enroll patients with spine disease, randomize, and assign them to the unilateral biportal endoscopic (UBE) decompression technique treatment group, modification UBE procedure group, and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Neurogenic symptoms induced by lumbar disk herniation 2. Computed tomography and/or magnetic resonance imaging indicating single level LDH, radiologic finding in accordance with clinical neural distribution 3. History of failed conservative treatment 4. Follow-up for at least 3 months

Exclusion criteria

Exclusion criteria: 1. Lumbar instability, spondylolisthesis or deformity 2. Tumors, infections, or other lesions 3. Surgical history involving the corresponding segment 4. Delayed treated cauda equina syndrome or other irreversible neural deficits

Design outcomes

Primary

Measure	Time frame
Perioperative data: 1. Length of operation time measured using medical records after surgery 2. Endoscopy irrigation amount measured using medical records after surgery 3. Estimated blood loss measured using medical records after surgery 4. Complications measured using video records of the endoscopy and clinical charts after surgery Clinical outcomes are assessed at the time of discharge, and at 3, 6, and 12 months and followed by once per year postoperative until the end of this study: 1. Back pain and lower leg pain measured using a visual analog scale (VAS) 2. Functional recovery measured using the Oswestry Disability Index (ODI) 3. Overall treatment outcomes measured using the modified MacNab criteria	—

Measure

Time frame

Perioperative data: 1. Length of operation time measured using medical records after surgery 2. Endoscopy irrigation amount measured using medical records after surgery 3. Estimated blood loss measured using medical records after surgery 4. Complications measured using video records of the endoscopy and clinical charts after surgery Clinical outcomes are assessed at the time of discharge, and at 3, 6, and 12 months and followed by once per year postoperative until the end of this study: 1. Back pain and lower leg pain measured using a visual analog scale (VAS) 2. Functional recovery measured using the Oswestry Disability Index (ODI) 3. Overall treatment outcomes measured using the modified MacNab criteria

—

Secondary

Measure	Time frame
1. Hemoglobulin concentration in wash out measured using spectrophotometry according to the haemoglobincyanide method after surgery 2. Amount of bone harvested measured using collecting bone debris and calculated in volume by syringe cylinder after surgery 3. Accuracy of the pedicle screw placement measured using CT scanning after surgery 4. Fusion condition measured using CT scanning at 1 year and later follow-up after surgery 5. Cross-section area in decompression segment measured using CT and MRI scanning at 3 months follow-up after surgery 6. Irrigation pressure measured using a liquid manometer from a lumbal puncture set during surgery 7. Supplement in irrigation measured using medical records after surgery	—

Measure

Time frame

1. Hemoglobulin concentration in wash out measured using spectrophotometry according to the haemoglobincyanide method after surgery 2. Amount of bone harvested measured using collecting bone debris and calculated in volume by syringe cylinder after surgery 3. Accuracy of the pedicle screw placement measured using CT scanning after surgery 4. Fusion condition measured using CT scanning at 1 year and later follow-up after surgery 5. Cross-section area in decompression segment measured using CT and MRI scanning at 3 months follow-up after surgery 6. Irrigation pressure measured using a liquid manometer from a lumbal puncture set during surgery 7. Supplement in irrigation measured using medical records after surgery

—

Countries

China

Contacts

Public ContactResearch Office

Keyanchu_jst_hosp@163.comNone available

Outcome results

None listed

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