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

Lumbar Spinal Stenosis Clinical Trial

— ARCHIMEDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06335511
• Other study ID #: 631-2021-OSS-AUSLBO
• Status: Recruiting
• Start date: October 10, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Azienda Usl di Bologna
• Contact: Alfredo Conti, Prof.
• Phone: +393382131017
• Email: alfredo.conti2[@]unibo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Lumbar Spinal Stenosis
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• microsurgical decompression
decompression of neurological structures
• decompression and instrumented fusion
decompression of neurological structures and spine stabilization

Locations

Country	Name	City	State
Italy	IRCCS Istituto delle Scienze Neurologiche di Bologna	Bologna
Italy	IRCCS Istituto Ortopedico Rizzolo	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Usl di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Ap — View Citation

Overdevest GM, Jacobs W, Vleggeert-Lankamp C, Thome C, Gunzburg R, Peul W. Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis. Cochrane Database Syst Rev. 2015 Mar 11;(3):CD010036. doi: 10.1002/1 — View Citation

Schmidt S, Franke J, Rauschmann M, Adelt D, Bonsanto MM, Sola S. Prospective, randomized, multicenter study with 2-year follow-up to compare the performance of decompression with and without interlaminar stabilization. J Neurosurg Spine. 2018 Apr;28(4):40 — View Citation

Scholler K, Alimi M, Cong GT, Christos P, Hartl R. Lumbar Spinal Stenosis Associated With Degenerative Lumbar Spondylolisthesis: A Systematic Review and Meta-analysis of Secondary Fusion Rates Following Open vs Minimally Invasive Decompression. Neurosurge — View Citation

Weiss AJ, Elixhauser A, Andrews RM. Characteristics of Operating Room Procedures in U.S. Hospitals, 2011. 2014 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Qualit — View Citation

Zaina F, Tomkins-Lane C, Carragee E, Negrini S. Surgical versus non-surgical treatment for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD010264. doi: 10.1002/14651858.CD010264.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form 12	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.	at baseline (day 0)
Primary	Short Form 12	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.	an average of 5 days (from baseline)
Primary	Short Form 12	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.	1 months (day 30)
Primary	Short Form 12	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.	3 months (day 90)
Primary	Visual Analogue Scale	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).	at baseline (day 0)
Primary	Visual Analogue Scale	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).	an average of 5 days (from baseline)
Primary	Visual Analogue Scale	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).	1 months (day 30)
Primary	Visual Analogue Scale	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).	3 months (day 90)
Primary	Oswestry Disability Index	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.	at baseline (day 0)
Primary	Oswestry Disability Index	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.	an average of 5 days (from baseline)
Primary	Oswestry Disability Index	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.	1 months (day 30)
Primary	Oswestry Disability Index	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.	3 months (day 90)
Primary	EuroQol-5D	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).	at baseline (day 0)
Primary	EuroQol-5D	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).	an average of 5 days (from baseline)
Primary	EuroQol-5D	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).	1 months (day 30)
Primary	EuroQol-5D	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).	3 months (day 90)
Primary	Postural Balance	Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).	at baseline (day 0)
Primary	Postural Balance	Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).	an average of 5 days (from baseline)
Primary	Postural Balance	Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).	1 months (day 30)
Primary	Postural Balance	Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).	3 months (day 90)
Primary	Locomotor performance	Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).	at baseline (day 0)
Primary	Locomotor performance	Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).	an average of 5 days (from baseline)
Primary	Locomotor performance	Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).	1 months (day 30)
Primary	Locomotor performance	Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).	3 months (day 90)
Primary	Spinal mobility	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).	at baseline (day 0)
Primary	Spinal mobility	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).	an average of 5 days (from baseline)
Primary	Spinal mobility	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).	1 months (day 30)
Primary	Spinal mobility	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).	3 months (day 90)
Secondary	Evaluation of costs	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).	after 3 years