Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)

NCT04406987 | Completed DMC

• 2 other identifiers: 20/717620202000-22
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

Age related changes in the lumbar spine can lead to narrowing of the spinal canal (spinal stenosis) causing leg and back pain. Spinal stenosis can be associated with a misalignment of the spine caused by forward slippage of a vertebrae over another. This instability is diagnosed using diagnostic imaging. With signs of instability the spine surgeon might choose a fusion of the vertebrae. This is a more complex procedure in relation to the simple decompression preformed without instability for spinal stenosis. The purpose of this study is to identify characteristics of instability of the lumbar spine on diagnostic imaging, and investigate associations with surgical data and patient reported outcomes from the National Spine databases from Denmark and Sweden. This will support spine surgeons in providing evidence-based surgical treatment for spinal stenosis with or without signs of instability

Conditions

Degenerative Lumbar Spinal Stenosis; Degenerative Spondylolisthesis

Keywords

instability; anterior translation; slip; segmental motion; radiologic assesment; lumbar MRI; MRI characteristics

Outcome Measures

Primary Outcomes (1)

• facet joint gap

  MRI proxies 1

  pre-surgery

Secondary Outcomes (5)

• facet angel

  pre-surgery

• disc height

  pre-surgery

• anterior translation

  pre-surgery

• intradiscal vacuum

  pre-surgery

• radiographic slip

  pre-surgery

Other Outcomes (7)

• VAS leg

  pre-surgery and 3 months, 12 months and 2 years post-surgery

• VAS back

  pre-surgery and 3 months, 12 months and 2 years post-surgery

• EQ-5D

  pre-surgery and 3 months, 12 months and 2 years post-surgery

Study Arms (2)

decompression

patients treated with decompression for lumbar spinal stenosis

Procedure: decompression

fusion

patients treated with decompression with fusion for lumbar spinal stenosis

Procedure: fusion

Interventions

decompression PROCEDURE

surgical technique for neural decompression varied based on surgeon's preference, but always with preservation for spinous processes. Either open with or without microscope or using tubular retractors.

decompression

fusion PROCEDURE

fusion techniques consisted besides decompression of additional implantation of pedicle screws with rods, with or without intervertebral fusion and cage(s). Non-instrumented technique with allograft bone. Fusion technique on surgeon's discretion.

Also known as: arthrodese

fusion

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with symptomatic, MRI-verifeis lumbar spinal stenosis referred to Spine Center of Southern Denmark between 2010-2017. And same study population referred to Spine Centers at hospitals in Malmö, Lund, Trelleborg and Karlskroga Sweden between 2010-2017.

You may qualify if:

• \- MRI verified spinal stenosis patients with or with out degenerative spondylolisthesis (\> 3mm anterior translation in lumbar MRI), who underwent surgery at L4/L5 level with either decompression alone or decompression with fusion between 2010 and 2017. Included ICD-10 diagnostic groups DM480 and DM431. Must have standing lateral radiographs preoperatively. Completed 2 year follow up.

You may not qualify if:

• previous surgery at the same level,
• malignancy or undergoing treatment for malignancy
• scoliosis Cobb angel \>20 degrees

Sponsors & Collaborators

• Spine Centre of Southern Denmark: lead

Study Sites (1)

Center for spine surgery and research, Spine Center of Southern Denmark

Middelfart, 5500, Denmark

Location

MeSH Terms

Interventions

Decompression; Gene Fusion; Arthrodesis

Intervention Hierarchy (Ancestors)

Therapeutics; Pressure; Mechanical Phenomena; Physical Phenomena; Recombination, Genetic; Genetic Phenomena; Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Signe Forbech Elmose, M.D.

  Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: May 29, 2020
• Study Start: June 30, 2021
• Primary Completion: December 5, 2021
• Study Completion: December 10, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)