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Completed

NCT Number: NCT03876275

Comparative Study of Arthrodeses by "Single Posterior Approach" and by "Double Anterior and Posterior Approach"

Extended arthrodesis of the spine is indicated in the treatment of deformities. The principle of the intervention is to correct the spinal imbalance and to obtain a fusion of the vertebral segment operated in order to guarantee the durability of this correction, in order to guarantee a functional result the best possible one.

There is a great disparity in the techniques available to obtain this result: as regards the correction of the deformation itself, it is possible to resort to various types of gestures aimed at "freeing" the spine to allow the getting the correction. It may be staged or transpedicular osteotomies or previous releases (staged discectomies). Regarding the arthrodesis itself, this can be obtained by an isolated posterior graft or by a circumferential graft itself performed in a time using interbody cages PLIF type (posterior lumbar interbody fusion) or TLIF (transforaminal interbody fusion) or in two stages by a complementary anterior graft. These are heavy interventions with a high complication rate.

The choice of this or that technique is based on data from the literature and remains at the discretion of the surgeon who makes the surgical indication. However, it has never been possible to compare these different techniques in a prospective study. The few articles comparing the different techniques tend to show that there is no significant difference between the techniques with a higher complication rate for the two-step techniques. However, these are retrospective studies, with all the biases that this implies and despite these results the disparity in surgical indications remains substantial.

The objective of this work is therefore to evaluate, according to an identical protocol, the different surgical techniques for the treatment of spinal deformities associated with a fusion in order to determine the morbidity associated with each of the techniques and if this morbidity is justified by a better functional result at a minimum follow-up of two years.

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Key information

Conditions

Spinal Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient whose age ≥ 18 years
  • Patient operated on an arthrodesis including the sacrum and extending to T11 or greater
  • Francophone patient
  • Patient not opposing his participation in the research protocol

Exclusion criteria

  • Patient under tutorship or curatorship
  • Patient deprived of liberty

Treatment and study plan

Primary outcomes

  1. Surgical revision rate

    Time frame: year 2

    Surgical revision rate following double-approach techniques and single posterior approach techniques

Secondary outcomes

  1. duration of the procedure

    Time frame: Day 1

    duration of the procedure

  2. bleeding during the procedure

    Time frame: Day 1

    bleeding volume during the procedure

  3. quality of life questionnary Oswestry v2

    Time frame: Day 0

    The quality of life questionnary Oswestry v2 before surgery corresponds to the score 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain and 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  4. quality of life questionnary SF-12

    Time frame: Day 0

    The quality of life questionnary SF-12 before surgery corresponds to a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).

  5. Visual Analog Score for pain

    Time frame: Day 0

    The visual Analog Score for pain before surgery corresponds to a score between 0 to 10.

  6. quality of life questionnary Oswestry v2

    Time frame: year 1

    The quality of life questionnary Oswestry v2 one year after surgery corresponds to the score 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain and 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  7. quality of life questionnary SF-12

    Time frame: year 1

    The quality of life questionnary SF-12 one year after surgery to a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).

  8. Visual Analog Score for pain

    Time frame: year 1

    The pain evaluation with Visual analogue scale one year after surgery corresponds to a score between 0 to 10.

  9. quality of life questionnary Oswestry v2

    Time frame: year 2

    The quality of life questionnary Oswestry v2 two years after surgery corresponds to the score 0% -20%: Minimal disability; 21%-40%: Moderate Disability; 41%-60%: Severe Disability; 61%-80%: Crippling back pain and 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms.

  10. quality of life questionnary SF-12

    Time frame: year 2

    The quality of life questionnary SF-12 two years after surgery to a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).

  11. Visual Analog Score for pain

    Time frame: year 2

    The pain evaluation with Visual analogue scale two years after surgery corresponds to a score between 0 to 10.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

Comparative Study of Arthrodeses in One Time by "Single Posterior Approach" and Two-stage Arthrodeses by "Double Anterior and Posterior Approach"

Acronym: ARBORD

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Mar 15, 2019
Registry last updated
Sep 13, 2023

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

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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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