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

NCT02881593 | Withdrawn DMC

• 1 other identifier: ARTHROSCAN
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthrodesis

Keywords

Operating in Minimally Invasive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Assessment of change of Oswestry score

  Day -1 and Day 1 after surgery

• Evaluation of pain by visual analogue scale VAS

  Day -1 and Day 1 after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Ductal compression on one floor
• Scanner spine preoperatively

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Guillaume P RIOUALLON, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: August 29, 2016
• Study Start: February 2, 2015
• Primary Completion: February 2, 2015
• Study Completion: February 2, 2015
• Last Updated: August 10, 2018

Record last verified: 2018-08