NCT05963815

Brief Summary

Our primary objective is to design a cohort to determine the treatment outcome of different surgical interventions of the degenerative lumbar spine highlighting the expediency and value of the current surgical treatment program.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2023Jan 2030

Study Start

First participant enrolled

January 13, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2030

Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

7 years

First QC Date

July 19, 2023

Last Update Submit

September 26, 2023

Conditions

Lumbar Disc HerniationSpondylolisthesisSpinal Stenosis

Keywords

Patient related outcome measuresPrognosisDegenerative Spine disease

Outcome Measures

Primary Outcomes (2)

  • Pain and functionality - COMI BACK

    The Core Outcome Measures Index (COMI) Back index score (range 0-10) is calculated by averaging transformed core-item scores from each domain of the five domains: pain symptoms (including NRS-scale), functionality of back, symptom-specific well-being, general well-being, and disability. Although the Oswestry disability index (ODI) is the most commonly used and cited tool, the COMI Back was chosen instead to assess pain intensity, functionality and disability within the study group. The COMI back is relatively short (7 questions), includes the NRS-scale (painscore from 0 (no pain) - 10 (worst possible pain), and has been cross-culturally adapted and validated in several languages, including in Dutch. It is the preferred tool of the Eurospine Registry.

    Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery

  • Health status - EQ5DL

    The eq-5D-5L (Euroquality 5 domains 5 level) health questionnaire provides a simple descriptive profile and a single index value for health status. The EQ-VAS is part of the EQ-5D-5L and it is a visual scale in which the patient can indicate the perception of their health status at the time of assessment, with 100 being perfect health status and 0 the worst health status. With the EQ-5D-5L we can assess the quality-adjusted life years (QALY).

    Baseline preoperative (about 2 weeks pre surgery). After completing the baseline measurements, the patients are asked to repeat the survey post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery

Secondary Outcomes (3)

  • Number of Re-operations

    post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery

  • Complication

    post surgery on set dates; 6 weeks-6months-12months-24 months-and 36 months post surgery

  • Satisfaction

    6 weeks, 6-12-36 months post surgery

Study Arms (1)

Degenerative spine disorder

Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.

Other: Spine surgery

Interventions

Spine surgeryOTHER

Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

Degenerative spine disorder

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are eligible for surgical treatment of the spine, including a lumbar herniated disk or lumbar spinal canal stenosis, discopathy and spondylolisthesis.

You may qualify if:

  • All patients who are eligible for elective surgery of the lumbar spine.
  • All patients with degenerative disorder of the lumbar spine including: herniated disk, stenosis, discopathy and spondylolisthesis.
  • Patients must be able to fill in the questionnaire online
  • Patients with imaging (Magnetic resonance imaging (MRI)) confirmed lumbar disc herniation, stenosis, discopathy, or listhesis.
  • Elective cases
  • Patients operated with laminectomy, microscopic discectomy, percutaneous transforaminal endoscopic discectomy, and spondylodesis.

You may not qualify if:

  • Patients who cannot speak nor read the Dutch language
  • Patients who are not able to complete the digital questionnaires, according to the including doctor
  • Patients with fractures, primary infections of the spine, or with spinal malignant- cies.
  • Patients in a traumatic setting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Park Medical Center

Rotterdam, South Holland, 30677 GH, Netherlands

RECRUITING

Related Publications (11)

  • Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21.

    PMID: 29573870BACKGROUND

  • Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

    PMID: 24665116BACKGROUND

  • Parenteau CS, Lau EC, Campbell IC, Courtney A. Prevalence of spine degeneration diagnosis by type, age, gender, and obesity using Medicare data. Sci Rep. 2021 Mar 8;11(1):5389. doi: 10.1038/s41598-021-84724-6.

    PMID: 33686128BACKGROUND

  • Konstantinou K, Dunn KM. Sciatica: review of epidemiological studies and prevalence estimates. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72. doi: 10.1097/BRS.0b013e318183a4a2.

    PMID: 18923325BACKGROUND

  • Grotle M, Smastuen MC, Fjeld O, Grovle L, Helgeland J, Storheim K, Solberg TK, Zwart JA. Lumbar spine surgery across 15 years: trends, complications and reoperations in a longitudinal observational study from Norway. BMJ Open. 2019 Aug 1;9(8):e028743. doi: 10.1136/bmjopen-2018-028743.

    PMID: 31375617BACKGROUND

  • Guzman JZ, Cutler HS, Connolly J, Skovrlj B, Mroz TE, Riew KD, Cho SK. Patient-Reported Outcome Instruments in Spine Surgery. Spine (Phila Pa 1976). 2016 Mar;41(5):429-37. doi: 10.1097/BRS.0000000000001211.

    PMID: 26571179BACKGROUND

  • Asher AL, Knightly J, Mummaneni PV, Alvi MA, McGirt MJ, Yolcu YU, Chan AK, Glassman SD, Foley KT, Slotkin JR, Potts EA, Shaffrey ME, Shaffrey CI, Haid RW, Fu KM, Wang MY, Park P, Bisson EF, Harbaugh RE, Bydon M. Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry. Neurosurg Focus. 2020 May 1;48(5):E2. doi: 10.3171/2020.2.FOCUS207.

    PMID: 32357320BACKGROUND

  • van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, Fritzell P. Evidence and practice in spine registries. Acta Orthop. 2015;86(5):534-44. doi: 10.3109/17453674.2015.1043174.

    PMID: 25909475BACKGROUND

  • Gadjradj PS, Chin-See-Chong TC, Donk D, Depauw P, Tulder MWV, Harhangi BS. Cross-Cultural Adaptation and Psychometric Validation of the Dutch Version of the Core Outcome Measures Index for the Neck in Patients Undergoing Surgery for Degenerative Disease of the Cervical Spine. Neurospine. 2021 Dec;18(4):798-805. doi: 10.14245/ns.2142682.341. Epub 2021 Dec 31.

    PMID: 35000334BACKGROUND

  • Mannion AF, Vila-Casademunt A, Domingo-Sabat M, Wunderlin S, Pellise F, Bago J, Acaroglu E, Alanay A, Perez-Grueso FS, Obeid I, Kleinstuck FS; European Spine Study Group (ESSG). The Core Outcome Measures Index (COMI) is a responsive instrument for assessing the outcome of treatment for adult spinal deformity. Eur Spine J. 2016 Aug;25(8):2638-48. doi: 10.1007/s00586-015-4292-4. Epub 2015 Oct 30.

    PMID: 26519374BACKGROUND

  • Devlin NJ, Brooks R. EQ-5D and the EuroQol Group: Past, Present and Future. Appl Health Econ Health Policy. 2017 Apr;15(2):127-137. doi: 10.1007/s40258-017-0310-5.

    PMID: 28194657BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DisplacementSpondylolisthesisSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSpondylolysisSpondylosis

Central Study Contacts

Annegien Boeykens, MD

CONTACT

010 436 1537a.boeykens@parkmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

January 13, 2023

Primary Completion (Estimated)

January 13, 2030

Study Completion (Estimated)

January 13, 2030

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)