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

Recruiting

• Conditions: Lumbar Spinal Stenosis; Degenerative Lumbar Spinal Stenosis
• Interventions: Procedure: microsurgical decompression; Procedure: decompression and instrumented fusion

• Registration Number: NCT06335511
• Lead Sponsor: Azienda Usl di Bologna

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2022-10-10
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-28
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Decompression	microsurgical decompression	microsurgical decompression (MiD)
Fusion	decompression and instrumented fusion	decompression and instrumented fusion (MiD + F)

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	3 months (day 90)	The Oswestry Disability Index (ODI) is a patient-completed questionnaire which gives a percentage score, from 0% (no disability) to 100% (complete disability), of level of function (disability). It is made of ten questions and for each question there are six possible answers.
EuroQol-5D	3 months (day 90)	The EuroQol-5D (EQ-5D) is an instrument for measuring quality of life. The score is based on two part. The first part includes five questions with three answers with a range from 1 (best outcome) to 3 (worst outcome). The second part consists in a numeric scale from 0 (worst outcome) to 100 (best outcome).
Locomotor performance	3 months (day 90)	Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).
Spinal mobility	3 months (day 90)	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).
Short Form 12	3 months (day 90)	The Short Form-12 (SF-12) healthy questionnaire is a generic standardized instrument assessing the impact of health on quality of life. It is made of twelve questions from which are calculated two different score: a Physical Component Score (with a score range 23,99 - 56,57) and a Mental Component Score (with a score range 19,06 - 60,75). The higher the number the better the outcome.
Visual Analogue Scale	3 months (day 90)	The Visual Analogue Scale (VAS) is a pain rating scale, where the minimum score is 0 (no pain) and maximum score is 10 (maximum pain imaginable).
Postural Balance	3 months (day 90)	Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).

Secondary Outcome Measures

Name	Time	Method
Evaluation of costs	after 3 years	The secondary outcome aims to compare the costs related to the two procedures themselfs (costs of the surgical procedure, hospital stay, blood transfusion, use of pain medications), but also the social costs related to absence from work (no min or max score available).

Trial Locations

Locations (2)

IRCCS Istituto Ortopedico Rizzolo; 🇮🇹 Bologna, Italy

IRCCS Istituto delle Scienze Neurologiche di Bologna; 🇮🇹 Bologna, Italy