Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion

NCT ID: NCT04469387

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2032-08-01

Brief Summary

This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for degenerative disease are prospectively enrolled and followed. Patients enrolled in this study have asymptomatic pre-existing spinal canal stenosis at adjacent segment. This study will focus on the effects of preventative limited decompression at adjacent segment.

Detailed Description

Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been troubling complications. The development of ASDis greatly reduces postoperative quality of life, and revision surgery may be required in severe cases. Several risk factors for ASP have been reported, such as age, sex, pre-existing adjacent degeneration, multilevel fusions, sagittal imbalance, the type of fusion, facet tropism and laminar inclination. Previous studies have reported asymptomatic pre-existing spinal canal stenosis (SCS) as a risk factor for ASDis that requires additional surgery. Appropriate strategy needs to be explored for the treatment of asymptomatic pre-existing spinal canal stenosis.

Limited decompressions, including partial laminotomy and flavectomy, have been proved to have the role of enlargement in spinal canal. Therefore, we hypothesize that limited decompressions at adjacent segment with asymptomatic pre-existing SCS will have the preventive effect on ASP.

This prospective study will be limited to patients with the same preoperative pathology, the same fusion segments (L4-5 and L5-S1), the same fusion technique (PLIF). Dynamic X-ray and MRI examinations of lumbar will be completed to evaluate the imaging manifestations of the responsible and adjacent segments before surgery. Patients with asymptomatic pre-existing canal stenosis factors (cerebrospinal fluid occlusion grade 1) at L3/4 segment will be enrolled. Patients will be randomly divided into two groups according to different strategies. NS Group includes patients who simply receive responsible segments fused (L4-S1). LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4). In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.

The patient's age, gender, preoperative body mass index (BMI), American Society of Anesthesiologists classification of anesthesia (ASA grade) will be recorded during the hospital stay. Surgical data including operation time, blood loss, perioperative complications (including cerebrospinal fluid leakage, wound infection, postoperative neurological dysfunction, and perioperative secondary surgery, cardiopulmonary complication, cerebral infarction/hemorrhage, etc.), and length of hospital stay are also recorded. Preoperative clinical function questionnaires, including visual analog scale (VAS) of low back, VAS of the legs, and Oswestry Disability Index (ODI) scores for patients were completed on admission for surgery without any assistance. All the patients enrolled will finished the follow-up from date of surgery at 1,2, 5 and 10 years. The clinical outcomes and ASP will be recorded.

Conditions

Degenerative Lumbar Spinal Stenosis; Degenerative Disc Disease; Degeneration Spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NS Group

NS Group includes patients who simply receive responsible segments fused (L4-S1).

Group Type: ACTIVE_COMPARATOR

Responsible segments fused

Intervention Type: PROCEDURE

In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).

LD Group

LD Group includes patients who receive responsible segments fused (L4-S1) plus limited decompression at adjacent segment (L3/4).

Group Type: EXPERIMENTAL

Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis

Intervention Type: PROCEDURE

In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.

Responsible segments fused

Intervention Type: PROCEDURE

In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).

Interventions

Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis

In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.

Intervention Type: PROCEDURE

Responsible segments fused

In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• A clear diagnosis of lumbar spinal stenosis, and surgical level of L4-S1 (The levels to be operated on were decided by matching the clinical symptomatology with the radiological findings of the spinal levels that needed decompression);
• Patients have asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid occlusion grade=1) at adjacent segment.
• Failed at least eight weeks conservative treatment;

Exclusion Criteria

• Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4;
• Preoperative sagittal and coronal imbalance of the spine;
• Lumbar infection and/or tumor diseases;
• A previous history of lumbar fusion surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Shi Li, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhuo Ran Sun, Dr.

Role: CONTACT

puh3_szr@outlook.com

+8618610292513

Facility Contacts

Da Zou, M.D.

Role: primary

zd_puth@163.com

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Other Identifiers

M2020285

Identifier Type: -

Identifier Source: org_study_id