Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation

This study is currently recruiting participants.
Verified July 2012 by General Hospital Amstetten
Sponsor:
Information provided by (Responsible Party):
Dr. Wolfgang Senker, General Hospital Amstetten
ClinicalTrials.gov Identifier:
NCT01259960
First received: December 14, 2010
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and analyzing the effect of body mass index (BMI) and wound healing.


Condition
Degenerative Lumbar Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation.

Resource links provided by NLM:


Further study details as provided by General Hospital Amstetten:

Primary Outcome Measures:
  • Operation related complications [ Time Frame: between operation and hospital discharge of patient ] [ Designated as safety issue: No ]
  • Post operative fever [ Time Frame: between operation and hospital discharge of patient ] [ Designated as safety issue: No ]
  • Liquor leakage [ Time Frame: between operation and hosital discharge of patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 258
Study Start Date: February 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
BMI < 25
25 <= BMI < 30
BMI >= 30

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients who will undergo minimal access surgical technige for degenerative lumbar disease fusion

Criteria
  • All patients who will undergo minimally access surgical technique for degenerative lumbar disease fusion surger
  • Patient willing to participate in observational study and who signs patient information and patient consent form
  • patient older that 18 years
  • all products will be used within intended use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259960

Contacts
Contact: Wolfgang Senker, MD +43 (7472) 6040 ext 0 wolfgang.senker@me.com

Locations
Austria
General Hospital Recruiting
Amstetten, Austria
Contact: Wolfgang Senker, MD    +43 (7472) 6040 ext 0    wolfgang.senker@me.com   
Sponsors and Collaborators
Dr. Wolfgang Senker
Investigators
Principal Investigator: Wolfgang Senker, MD General Hospital Amstetten
  More Information

No publications provided

Responsible Party: Dr. Wolfgang Senker, Senior Consultant for orthopedy and orthopedic surgery, General Hospital Amstetten
ClinicalTrials.gov Identifier: NCT01259960     History of Changes
Other Study ID Numbers: 2-Senker
Study First Received: December 14, 2010
Last Updated: July 4, 2012
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on April 22, 2014