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

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.

Study Overview

• Status: Withdrawn
• Conditions: Arthrodesis

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with Paris Saint Joseph with canal compression on one floor, for whom a scan of the spine is performed preoperatively

Description

Inclusion Criteria:

• Ductal compression on one floor
• Scanner spine preoperatively

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing the measured height of the foramen on the CT scanner	The 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.	Day -1 and Day 1 after surgery
Assessment of change of MRI volume of dural sac	For central stenosis, Postoperative MRI will be performed and the volume of the dural sac will be compared to preoperative MRI on axial slices	Day -1 and Day 1 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of change of Oswestry score	Oswestry score (<30%: State almost normal 30 to 50%: Moderate disability 50% to 70%: Severe disability> 70%: full disability)	Day -1 and Day 1 after surgery
Evaluation of pain by visual analogue scale VAS		Day -1 and Day 1 after surgery

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Anticipated): February 2, 2015
• Primary Completion (Anticipated): February 2, 2015
• Study Completion (Anticipated): February 2, 2015

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Operating in Minimally Invasive
• Other Study ID Numbers: ARTHROSCAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided