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Full-Endoscopic Decompression (FED) versus Endoscopic Lumbar Interbody Fusion (Endo-LIF) in Middle-Aged and Older Adults with Lumbar Spinal Stenosis: A Prospective Randomized Controlled Trial

Full-Endoscopic Decompression (FED) versus Endoscopic Lumbar Interbody Fusion (Endo-LIF) in Middle-Aged and Older Adults with Lumbar Spinal Stenosis: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119389
Enrollment
Unknown
Registered
2026-02-26
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Lumbar spinal stenosis

Interventions

Full-Endoscopic Decompression Group:Full-Endoscopic Decompression

Sponsors

The First Affiliation Hospital with Nanjing Medical University (Jiangsu Province Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 50 and 75 years, regardless of gender. 2. A definitive diagnosis of lumbar spinal stenosis, presenting with typical clinical symptoms (e.g., lower extremity radiating pain, neurogenic claudication) and signs, confirmed by imaging (MRI or CT). 3. The lesion involves only a single spinal segment (L2-S1). 4. Failed to respond to at least three months of systematic conservative treatment, with a significant impact on quality of life, and the patient has a clear willingness to undergo surgery. 5. (Clinical equipoise) After evaluation by at least two senior spine surgeons, both agree that the patient's condition meets the surgical indications for both full-endoscopic decompression and endoscopic lumbar interbody fusion. 6. The patient fully understands the randomized nature of this study (including random assignment and the relinquishment of choice by both the physician and the patient) and voluntarily signs the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. Clear indications for fusion: Degenerative spondylolisthesis greater than Meyerding Grade I, presence of lumbar spondylolysis, or evidence of definite lumbar instability on flexion-extension radiographs (e.g., segmental translation > 3 mm or angular change > 10°). 2. Clear indications for decompression alone: Stenosis caused solely by soft disc herniation, without concomitant bony spinal canal or lateral recess stenosis. 3. Spinal stenosis due to non-degenerative causes: Presence of spinal stenosis caused by fracture, spinal tumor, active infection, or inflammatory disease (e.g., ankylosing spondylitis, rheumatoid arthritis). 4. Severe spinal structural abnormalities: Presence of severe spinal deformity (e.g., degenerative scoliosis with a Cobb angle > 20°). 5. History of relevant prior surgery: Previous lumbar surgery at the same or an adjacent segment. 6. Systemic diseases precluding tolerance to surgery: Presence of severe dysfunction of major organs (e.g., heart, lung, liver, kidney) or an American Society of Anesthesiologists (ASA) classification > III, indicating an inability to tolerate anesthesia or surgery upon evaluation. 7. Comorbidities that may confound outcome assessment: Presence of other conditions that could cause lower extremity claudication or dysfunction, such as severe hip or knee osteoarthritis (including a history of total hip or knee arthroplasty), peripheral vascular claudication, or polyneuropathy. Presence of other neurological or muscular system disorders that could seriously affect treatment evaluation (e.g., Parkinson's disease, amyotrophic lateral sclerosis). 8. Participation in other studies: Currently participating in other clinical trials that could potentially influence the results of this study.

Design outcomes

Primary

MeasureTime frame
Oswestry disability index, ODI;

Secondary

MeasureTime frame
Numeric Rating Scale Score;EuroQol 5-Dimension Questionnaire Score;Zurich Claudication Questionnaire, ZCQ;

Countries

China

Contacts

Public ContactRen Yongxin

The First Affiliation Hospital with Nanjing Medical University (Jiangsu Province Hospital)

renyongxinjsph@163.com+86 135 8516 2283

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026