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NCT Number: NCT05701046

Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis

Currently there is no consensus on the best surgical treatment of patients with symptomatic isthmic spondylolisthesis (IS). Clinical equipoise exists amongst experienced clinicians on the various surgical techniques available.

This study will involve multiple phases to answer specific research questions comparing anterior and posterior interbody fusion in patients with lumbar isthmic spondylolisthesis. The primary end point will be 1-year proportions of patients reaching minimal clinically important difference (MCID) in terms of leg pain measured by NRS leg. The secondary endpoints will be predetermined moderate to severe AEs, reoperations for nonunion, symptomatic adjacent segment disease, radiological alignment correction and correlation with HRQOL as well as economic analysis at 1, 2, 5 and 10 years.

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Key information

Conditions

Isthmic Spondylolisthesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V6H 1N1, Canada

Location status: Recruiting

Location contact

Charlotte Dandurand

CONTACT

[email protected]

(604) 875-5859

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female aged 18 years or older (or who have reached the age of majority in the participating province)
  • Require surgical treatment for a diagnosis of single-level lumbar isthmic spondylolisthesis, any grade, in the lumbar and lumbosacral spine.
  • Are able to communicate in English or French
  • Anterior interbody fusion group will be defined as having had an anterior or oblique approach with a synthetic cage insertion, interbody bone graft without cage or plate-screw construct with or without posterior rod-screw construct
  • Posterior interbody fusion group will have only posterior approach procedure.

Exclusion criteria

  • Previous spinal surgery
  • Specific pathology at level above and below:
  • Degenerative anterolisthesis
  • Pars defect above or below index level

Treatment and study plan

Interbody fusion surgery

Procedure

Interbody fusion surgery

Primary outcomes

  1. Proportions of patients reaching MCID for NRS leg at 1 year

    Time frame: at 1 year follow-up

    Proportions of patients reaching MCID for NRS leg (>=3)

Secondary outcomes

  1. Proportion of patients with any predefined adverse events

    Time frame: 3 month follow-up data

  2. Reoperation due to nonunion at index level or adjacent segment disease

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

  3. Change in radiological parameters

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

    Level, Labelle classification, Degree of translation, SVA, Lumbar lordosis, segmental lordosis, sacral and spinopelvic parameters,

  4. Correlation between improvement in radiological parameters and patient reported outcomes

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

  5. Change in Patient's reported outcome (PRO) : Numeric pain rating scale for back pain

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

  6. Change in Patient's reported outcome (PRO) : Oswestry disability index

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

  7. Change in Patient's reported outcome (PRO) : EuroQoL 5 dimension (EQ5D)

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

  8. Change in Patient's reported outcome (PRO) : 12 item short form survey (SF12)

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

  9. Change in Patient's reported outcome (PRO) : Patient Health Questionnaire Depression Scale (PHQ-8)

    Time frame: 1 year- 2 year -5 year -10 year follow-up data

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Dandurand

CONTACT

[email protected]

(604) 875-5859

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Anterior vs Posterior Surgery for Lumbar Isthmic Spondylolisthesis: Multicenter Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2028
Study completion
2038
First posted
Jan 27, 2023
Registry last updated
May 9, 2024

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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