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
NCT number | NCT04467944 |
Other study ID # | M2017399 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | December 31, 2032 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
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
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. |
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