Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery

Degenerative Disc Disease Clinical Trial

Official title:

Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467944
• Other study ID #: M2017399
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2032

Study information

• Verified date: June 2020
• Source: Peking University Third Hospital
• Contact: Zhuo Ran Sun, Dr.
• Phone: +8618610292513
• Email: puh3_szr[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for lumbar degenerative disease are prospectively enrolled and followed. Important adjacent pre-existing degeneration factors include discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). This study will focus on the effects of pre- existing adjacent degeneration (disc factors and spinal canal stenosis factors) on long-term postoperative outcomes.

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. Because multi-level degenerative imaging is common in lumbar degenerative disease, pre-existing adjacent degeneration makes challenge for the surgery strategy, sometimes it is difficult to determine the level at which fusion ends. Important pre-existing adjacent degeneration factors included discs degenerated, facets and ligamentum flavum tropism which could lead to spinal canal stenosis (SCS). Few studies have focused on asymptomatic pre-existing SCS as a risk factor for ASDis that requires additional surgery at an adjacent segment. But these studies only used the sagittal diameter or ratio to evaluate the degree of adjacent SCS. The status of neural tissues in the canal was neglected. Few studies also have focused on asymptomatic pre-existing degenerated disc as a risk factor for ASDeg. But these studies only used Pfirrmann grade to evaluate the degenerated disc. High-intensity zone (Hiz), vacuum sign were neglected.

This prospective study was 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. The T2-weighted sagittal and axial MRI images are studied and the following parameters are recorded: grade of cerebrospinal fluid occlusion in L3/4 spinal canal at disc level, and the narrowest axial plane was used for grading; L3/4 disc degeneration by Pfirrmann grade; high-intensity zone (Hiz) and vacuum sign of L3/4 disc; L3/4 disc herniation quantificationally measured by MSU Classification; Patients will be divided into three groups according to the pre-existing status of L3/4 segment. Patients without pre-existing degeneration at L3/4 segment will be classified into control group (NS group). Patients with pre-existing disc factors (Pfirrmann grade≥3, Hiz or vacuum sign) at L3/4 segment will be classified into group D. Patients with pre-existing canal stenosis factors (cerebrospinal fluid occlusion≥1) at L3/4 segment will be classified into group C.

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 and 5 years. The clinical outcomes and ASP will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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);

• 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.

Related Conditions & MeSH terms

• Degeneration Spine
• Degenerative Disc Disease
• Degenerative Lumbar Spinal Stenosis
• Intervertebral Disc Degeneration
• Spinal Stenosis

Intervention

Other:
• Pre-existing degenerative factors at adjacent segment
Pre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

Lawrence BD, Wang J, Arnold PM, Hermsmeyer J, Norvell DC, Brodke DS. Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review. Spine (Phila Pa 1976). 2012 Oct 15;37(22 Suppl):S123-32. doi: 10.1097/BRS.0b013e31826d60d8. — View Citation

Lee GY, Lee JW, Choi HS, Oh KJ, Kang HS. A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method. Skeletal Radiol. 2011 Aug;40(8):1033-9. doi: 10.1007/s00256-011-1102-x. Epub 2011 Feb 1. Erratum in: Skeletal Radiol. 2011 — View Citation

Lee JC, Kim Y, Soh JW, Shin BJ. Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion. Spine (Phila Pa 1976). 2014 Mar 1;39(5):E339-45. doi: 10.1097 — View Citation

Mysliwiec LW, Cholewicki J, Winkelpleck MD, Eis GP. MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection. Eur Spine J. 2010 Jul;19(7):1087-93. doi: 10.1007/s00586-009-1274-4. Epub 2010 Jan 19. — View Citation

Nakashima H, Kawakami N, Tsuji T, Ohara T, Suzuki Y, Saito T, Nohara A, Tauchi R, Ohta K, Hamajima N, Imagama S. Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up. Spine (Phila Pa 1976 — View Citation

Yugué I, Okada S, Masuda M, Ueta T, Maeda T, Shiba K. Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography. Eur Spine J. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjacent segment degeneration (ASDeg)	ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression =1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of = 3 mm in vertebral slippage, a change of = 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.	12 months after surgery
Primary	Adjacent segment degeneration (ASDeg)	ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression =1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of = 3 mm in vertebral slippage, a change of = 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.	24 months after surgery
Primary	Adjacent segment degeneration (ASDeg)	ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression =1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of = 3 mm in vertebral slippage, a change of = 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.	60 months after surgery
Primary	Adjacent segment degeneration (ASDeg)	ASDeg is defined as follows according to manifestations on X-rays and MRI changing from baseline : (1) Progression =1 grade in SCS or L3/4 disc degeneration; (2)Alteration of L3/4 disc herniation, Hiz and vacuum sign; (3) Progression of = 3 mm in vertebral slippage, a change of = 10° in the intervertebral angle on flexion and extension lateral radiograph, or scoliosis deformity on coronal plane.	120 months after surgery
Primary	Adjacent segment disease (ASDis)	ASDis is defined as clinical and radiographic evidence of degenerative spinal disease (disc degeneration, stenosis, or spondylolisthesis) on the level adjacent to the index fusion.	The entire study process, up to 120 months after surgery.
Secondary	Disability	The Oswestry Disability Index (ODI) (0-100) is used to assess disability.	12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Secondary	Back pain	The Visual Analog Scale (0-10) is used to evaluate back pain.	12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.
Secondary	Leg pain	The Visual Analog Scale (0-10) is used to evaluate leg pain.	12 months after surgery; 24 months after surgery; 60 months after surgery; 120 months after surgery.