Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Identification of clinical and instrumental parameters that could predict the outcome of surgical decompression of lumbar degenerative stenosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis

NCT04166981

Spinal Stenosis Spondylolisthesis Degenerative Spinal Fusion

COMPLETED NA

Comparison Between Surgical and Conservative Treatment for Lumbar Stenosis

NCT05315466

Lumbar Spinal Stenosis

COMPLETED NA

Decompression vs Physical Training for the Treatment of Lumbar Spinal Stenosis

NCT03495661

Spinal Stenosis Spinal Stenosis Lumbar Degeneration Lumbar Spine +3 more

COMPLETED NA

Interbody vs Instrumented Posterolateral Fusion Following Decompression for Lumbar Spinal Stenosis With Degenerative Spondylolisthesis

NCT01921530

Degenerative Spondylolisthesis Spinal Stenosis

UNKNOWN PHASE4

Balance Amongst Patients With Lumbar Spinal Stenosis

NCT06075862

Lumbar Spinal Stenosis

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Degenerative lumbar spine is the most common cause of chronic pain and disability with remarkable economic impact. Treatment begins with conservative options (physical combined with antalgic therapy) but often requires surgical treatment.

Two different groups of patients affected by symptomatic lumbar stenosis with no preoperative radiological signs of instability will be recruited in a prospective trial and proposed for surgery: microsurgical decompression (MiD) or decompression and instrumented fusion (MiD + F). Clinical and mechanical outcomes of two different treatments (MiD vs. MiD+F) will be compared.

An in-vitro biomechanical study will evaluate the biomechanical effect of the two surgical techniques.

The aim of this project is to obtain robust data for tailoring the surgical approach to patient individual characteristics and needs, to gain the best clinical evidence, and possibly reducing the overall costs of management of this disease.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spinal Stenosis Degenerative Lumbar Spinal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Decompression

microsurgical decompression (MiD)

microsurgical decompression

Intervention Type PROCEDURE

decompression of neurological structures

Fusion

decompression and instrumented fusion (MiD + F)

decompression and instrumented fusion

Intervention Type PROCEDURE

decompression of neurological structures and spine stabilization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microsurgical decompression

decompression of neurological structures

Intervention Type PROCEDURE

decompression and instrumented fusion

decompression of neurological structures and spine stabilization

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

decompression stabilization

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* degenerative lumbar stenosis caused by bone hypertrophy, osteoarthritis of facet joints, ligamentous hypertrophy, disc protrusion
* midsagittal spinal canal diameter of 12 mm or less
* no radiological signs of instability, i.e. pathological motion on preoperative dynamic lumbar X-ray
* ongoing symptoms for a minimum of 12 weeks with no improvement to conservative treatment
* eligibility for decompression alone (MiD) or decompression and fusion (MiD+F)

Exclusion Criteria

* congenital, traumatic, infectious and neoplastic lumbar stenosis,
* spondylolisthesis (on static X-ray), lumbar scoliosis (Cobb\>10°),
* previous lumbar surgery, other types of operations (endoscopic decompression, anterior interbody fusions, interspinous devices etc.).
* patients with spine deformity requiring long fusion (i.e. \>=3 levels)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No