Percutaneous Trans-facet Screw Fixation Under CT-scan Guidance for Remaining Symptoms at a Distance of Previous Spinal Surgery

NCT05525052 | Completed

• 1 other identifier: 22-IMAGERIE-02
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Background : Segmental spinal instability after a laminectomy, and adjacent segment disease (ASD) at after an arthrodesis, are well-known concerns in spinal surgery, which may require re-interventions, usually by surgical arthrodesis, posing the problem of a new heavy intervention under general anesthesia, in often fragile patients. Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability. Purpose : The aim of our study is to evaluate the efficacy, in terms of pain reduction (VAS) and improvement of daily activities (ODI), of TFF under CT scan guidance in the context of low back pain and/or radiculalgia related to focal instability secondary to laminectomy or ASD. Methods : TFF were performed in 24 patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis and remaining symptomatic, at Nice University Hospital between 2017 and 2021 Pre- and postoperative pain and disability levels were measured using the visual analogue scale (VAS) and the Oswestry Disability Index (ODI), collected prospectively at systematic 6-month and 1-year follow-up visits. Long term evolution were assessed by phone consultation.

Conditions

Spinal Stenosis; Spinal Disease; Zygapophyseal Joint Arthritis; Joint Instability; Arthrodesis; Laminectomy; Post Laminectomy Syndrome

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) of pain and Oswestry Disability Index (ODI)

  Pre- and postoperative pain were measured using the visual analogue scale (VAS), from 0 (no pain) to 10 (maximal pain) collected prospectively at systematic 6-month visit.

  6 months

Secondary Outcomes (5)

• pain

  From 6 months (systematic consultation) to 4 yours (phone consultation)

• Disability

  From 6 months (systematic consultation) to 4 yours (phone consultation)

• Severe intraoperative and postoperative complications

  From 6 months (systematic consultation) to 4 yours (phone consultation)

• Need for further interventions afterward the procedure

  From 6 months (systematic consultation) to 4 yours (phone consultation)

• Mean procedure time

  At inclusion

Study Arms (1)

Cohort

Patients having a history of spinal surgery such as laminectomy and/or classic surgical arthrodesis, and subsequent focal spinal, treated by transfacet arthrodesis under CT scan guidance

Other: Trans-Facet fixation

Interventions

Trans-Facet fixation OTHER

Trans-facet fixation (TFF) under local anesthesia and double fluoroscopic and CT guidance is a minimally invasive technique involving the placement of screws through the posterior facet joints, improving spinal stability.

Cohort

Eligibility Criteria

• Age: 49 Years - 91 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated at Nice University Hospital between 2017 and 2021 by transfacet arthrodesis, with history of spinal surgery ( laminectomy and/or classic arthrodesis), andsigns of subsequent instability.

You may qualify if:

• History of spinal surgery ( laminectomy and/or classic arthrodesis) - Clinical signs of subsequent instability(low back pain and/or radiculopathy).
• MRI or scintigraphy signs of instability or ASD :
• Spondylolisthesis appeared or increased on successive exams
• Facet dislocation
• Subchondral bone changes of the vertebral endplates (Modic 1)
• Insufficient improvment after epidural and posterior joint corticosteroid infiltrations

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06001, France

Location

MeSH Terms

Conditions

Spinal Stenosis; Spinal Diseases; Joint Instability; Ankylosis; post laminectomy syndrome

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Joint Diseases

Study Officials

• Vincent SALA

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: January 1, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: September 6, 2022

Record last verified: 2022-08

Locations

FR (1)