Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT02881593
Status:
WITHDRAWN
Last Update Posted:
2018-08-10
First Post:
2016-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Quality of Post Release on Scanners Operating in Minimally Invasive Arthrodesis
Sponsor:
Fondation Hôpital Saint-Joseph
Organization:
Study Overview
Official Title:
Study of the Quality of the Release on Postoperative Scanners in Minimally Invasive Arthrodesis
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The investiagtor abandoned the project.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: