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Completed

NCT Number: NCT06335511

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

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

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Degenerative Lumbar Spinal Stenosis Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzolo, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

microsurgical decompression

Procedure

decompression of neurological structures

Other names: decompression

Decompression and instrumented fusion

Procedure

decompression of neurological structures and spine stabilization

Other names: stabilization

Primary outcomes

  1. Short Form 12

    Time frame: at baseline (day 0)

    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.

  2. Short Form 12

    Time frame: an average of 5 days (from baseline)

    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. Short Form 12

    Time frame: 1 months (day 30)

    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.

  4. Short Form 12

    Time frame: 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.

  5. Visual Analogue Scale

    Time frame: at baseline (day 0)

    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).

  6. Visual Analogue Scale

    Time frame: an average of 5 days (from baseline)

    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).

  7. Visual Analogue Scale

    Time frame: 1 months (day 30)

    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).

  8. Visual Analogue Scale

    Time frame: 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).

  9. Oswestry Disability Index

    Time frame: at baseline (day 0)

    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.

  10. Oswestry Disability Index

    Time frame: an average of 5 days (from baseline)

    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.

  11. Oswestry Disability Index

    Time frame: 1 months (day 30)

    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.

  12. Oswestry Disability Index

    Time frame: 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.

  13. EuroQol-5D

    Time frame: at baseline (day 0)

    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).

  14. EuroQol-5D

    Time frame: an average of 5 days (from baseline)

    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).

  15. EuroQol-5D

    Time frame: 1 months (day 30)

    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).

  16. EuroQol-5D

    Time frame: 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).

  17. Postural Balance

    Time frame: at baseline (day 0)

    Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).

  18. Postural Balance

    Time frame: an average of 5 days (from baseline)

    Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).

  19. Postural Balance

    Time frame: 1 months (day 30)

    Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).

  20. Postural Balance

    Time frame: 3 months (day 90)

    Descriptive evaluation of sway area, symmetry and visual integration performed with wearable sensors (no min or max score available).

  21. Locomotor performance

    Time frame: at baseline (day 0)

    Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).

  22. Locomotor performance

    Time frame: an average of 5 days (from baseline)

    Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).

  23. Locomotor performance

    Time frame: 1 months (day 30)

    Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).

  24. Locomotor performance

    Time frame: 3 months (day 90)

    Descriptive evaluation of similarity to reference, variability, complexity and regularity measured with wearable sensors (no min or max score available).

  25. Spinal mobility

    Time frame: at baseline (day 0)

    Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).

  26. Spinal mobility

    Time frame: an average of 5 days (from baseline)

    Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).

  27. Spinal mobility

    Time frame: 1 months (day 30)

    Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).

  28. Spinal mobility

    Time frame: 3 months (day 90)

    Descriptive evaluation of spinal mobility range and smoothness measured with wearable sensors (no min or max score available).

Secondary outcomes

  1. Evaluation of costs

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Acronym: ARCHIMEDE

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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