A comparative study of posterior supporting tissue injury between uniportal and biportal full-endoscopic lumbar decompression

Comparison of posterior supporting tissue injury between uniportal and biportal full-endoscopic lumbar decompression: a prospective observational study - FEL/AFESS posterior tissue injury study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061648

Enrollment

140

Registered

2026-05-21

Start date

2026-05-20

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Lumbar spinal stenosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing one- or two-level full-endoscopic lumbar decompression for lumbar spinal stenosis, mainly due to degenerative disease, at our hospital. 2. Patients undergoing either uniportal or biportal full-endoscopic lumbar decompression. 3. Patients aged 20 years or older at the time of surgery. 4. Patients who undergo preoperative MRI and MRI approximately 6 months after surgery and in whom the cross-sectional area of the multifidus muscle can be evaluated. 5. Patients who undergo postoperative CT at 1-2 days, postoperative MRI at 3-4 days, MRI approximately 6 months after surgery, and routine clinical symptom assessment according to the clinical pathway of our hospital.

Exclusion criteria

Exclusion criteria: 1. Patients whose main pathology is not lumbar spinal stenosis, such as tumor, infection, trauma, or inflammatory disease. 2. Patients undergoing concomitant fusion surgery. 3. Patients undergoing decompression at three or more levels. 4. Patients with a history of previous surgery at the target level. 5. Patients who cannot undergo preoperative MRI or MRI approximately 6 months after surgery due to contraindications to MRI or other reasons. 6. Patients in whom image assessment is technically difficult due to severe artifacts, inconsistent imaging range, or other reasons. 7. Patients who refuse the use of their information through the opt-out process. 8. Patients judged by the principal investigator to be inappropriate for this study.

Design outcomes

Primary

Measure	Time frame
Percent change in the cross-sectional area of the multifidus muscle from preoperative MRI to MRI approximately 6 months after surgery	—

Secondary

Measure	Time frame
Key secondary outcomes include absolute changes in multifidus cross-sectional area; changes in multifidus cross-sectional area on the approach and contralateral sides; dural sac cross-sectional area and its absolute and percent changes; early postoperative MRI findings; patient-reported outcomes before surgery and 3, 6, and 12 months after surgery; operative time; length of hospital stay; complications; reoperation; and readmission.	—

Measure

Time frame

Key secondary outcomes include absolute changes in multifidus cross-sectional area; changes in multifidus cross-sectional area on the approach and contralateral sides; dural sac cross-sectional area and its absolute and percent changes; early postoperative MRI findings; patient-reported outcomes before surgery and 3, 6, and 12 months after surgery; operative time; length of hospital stay; complications; reoperation; and readmission.

—

Countries

Japan

Contacts

Public ContactSadaaki Kanayama

Japan Community Healthcare Organization Osaka Hospital Department of Orthopaedic Surgery

drsada@jewel.ocn.ne.jp06-6441-5451

Outcome results