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Study of the Quality of Post Release on Scanners Operating in Minimally Invasive Arthrodesis

Study of the Quality of the Release on Postoperative Scanners in Minimally Invasive Arthrodesis

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02881593
Enrollment
0
Registered
2016-08-29
Start date
2015-02-02
Completion date
2015-02-02
Last updated
2018-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrodesis

Keywords

Operating in Minimally Invasive

Brief summary

For twenty years, as for other surgical disciplines, new minimally invasive techniques have been developed with the main goal the reduction of muscle trauma associated with the surrounding roads classic and reduce morbidity linked to this one. More recently, minimally invasive methods dedicated to spinal surgery were established, for the treatment of herniated discs initially, then for narrow lumbar canals. The canal release on minimally invasive fusion, using a tubular system for muscle retraction is a new technique that has proven effective: post operative pain reduction of hospital stay and blood loss. The objective of the study is to investigate the quality of ductal release in these minimally invasive fusions. Main objective of the study: Evaluation of the quality of the release of post scanners operative minimally invasive arthrodesis Secondary Objectives: Assessment rates/types of early complications of technical Minimally invasive - early postoperative results (postoperative pain, analgesic consumption, length of hospital stay, blood loss) - in clinical outcomes in the short and medium term decompression after minimally invasive fusion.

Detailed description

I. Background / Rationale For twenty years, as for other surgical disciplines, new minimally invasive techniques have been developed with the main goal the reduction of muscle trauma associated with the surrounding roads classic and reduce morbidity linked to this one. More recently, minimally invasive methods dedicated to spinal surgery were established, for the treatment of herniated discs initially, then for narrow lumbar canals. The canal release on minimally invasive fusion, using a tubular system for muscle retraction is a new technique that has proven effective: post operative pain reduction of hospital stay and blood loss. The objective of the study is to investigate the quality of ductal release in these minimally invasive fusions. II. objectives at. primary objective Evaluating the quality of discharge on postoperative scanners minimally invasive fusions. b. secondary objectives i. Evaluation of the rate and type of early complications in the minimally invasive technique ii. Evaluation of early postoperative results (postoperative pain, analgesic consumption, length of hospital stay, blood loss) iii. Evaluation of clinical outcomes in the short and medium term decompression after minimally invasive fusion. III. Methodology and duration of the research This is a retrospective single-center consecutive series multi-operator regarding the evaluation of surgical practice cited in goal. Clinical data were collected prospectively by KEOPS database (SAMIO). All patients included in our study have spinal MRI scanners and pre-operative and post-operative scans. N = (number of patients and over what period) / Time Study? The series of patients will be classified into two groups: * Foraminal stenosis * Central stenosis The evaluation of the primary objective criterion is comparing the height of the foramen measured on CT pre- and post-operative between the lower edge of the overlying pedicle and the top edge of the pedicle underlying the sagittal sections. For central stenosis, Postoperative MRI will be performed and the volume of the dural sac will be compared to preoperative MRI on axial images.

Interventions

None listed

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Ductal compression on one floor * Scanner spine preoperatively

Exclusion criteria

* Spondylolisthesis significant (greater than grade 2) * Stenoses multi layered * Major spinal deformities

Design outcomes

Primary

MeasureTime frameDescription
comparing the measured height of the foramen on the CT scannerDay -1 and Day 1 after surgeryThe evaluation of the primary objective criterion is comparing the height of the foramen measured on CT pre- and post-opéraoires between the lower edge of the overlying pedicle and the top edge of the pedicle underlying the sagittal sections.
Assessment of change of MRI volume of dural sacDay -1 and Day 1 after surgeryFor central stenosis, Postoperative MRI will be performed and the volume of the dural sac will be compared to preoperative MRI on axial slices

Secondary

MeasureTime frameDescription
Assessment of change of Oswestry scoreDay -1 and Day 1 after surgeryOswestry score (\<30%: State almost normal 30 to 50%: Moderate disability 50% to 70%: Severe disability\> 70%: full disability)
Evaluation of pain by visual analogue scale VASDay -1 and Day 1 after surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026