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

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: microsurgical decompression; Procedure: decompression and instrumented fusion

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40136
      • IRCCS Istituto Ortopedico Rizzolo
    • Bologna, Bologna, Italy, 40139
      • IRCCS Istituto delle Scienze Neurologiche di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

adult (>18yrs-old) patients with symptomatic degenerative lumbar stenosis.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Decompression; microsurgical decompression (MiD)	Procedure: microsurgical decompression; decompression of neurological structures; Other Names: decompression
Fusion; decompression and instrumented fusion (MiD + F)	Procedure: decompression and instrumented fusion; decompression of neurological structures and spine stabilization; Other Names: stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Spinal mobility	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).	at baseline (day 0)
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)
Spinal mobility	Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).	1 months (day 30)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Azienda Usl di Bologna
• Investigators: Principal Investigator: Alfredo Conti, Prof., IRCCS Istituto delle Scienze Neurologiche di Bologna

Publications and helpful links

General Publications

• 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.
• 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. Neurosurgery. 2017 Mar 1;80(3):355-367. doi: 10.1093/neuros/nyw091.
• 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 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
• 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):406-415. doi: 10.3171/2017.11.SPINE17643. Epub 2018 Jan 26.
• 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 Quality (US); 2006 Feb-. Statistical Brief #170. Available from http://www.ncbi.nlm.nih.gov/books/NBK195245/
• 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;2015(3):CD010036. doi: 10.1002/14651858.CD010036.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis; Therapeutics; Mechanical Phenomena; Physical Phenomena; Pressure; Decompression
• Other Study ID Numbers: 631-2021-OSS-AUSLBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No