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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259960
First Posted: December 15, 2010
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Wolfgang Senker, General Hospital Amstetten
  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.

Further study details as provided by Dr. Wolfgang Senker, General Hospital Amstetten:

Primary Outcome Measures:
  • Operation related complications [ Time Frame: between operation and hospital discharge of patient ]
  • Post operative fever [ Time Frame: between operation and hospital discharge of patient ]
  • Liquor leakage [ Time Frame: between operation and hosital discharge of patient ]

Enrollment: 187
Study Start Date: February 2011
Study Completion Date: February 2017
Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
BMI < 25
Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
25 <= BMI < 30
Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
BMI >= 30
Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259960


Locations
Austria
General Hospital
Amstetten, Austria
Sponsors and Collaborators
Dr. Wolfgang Senker
Investigators
Principal Investigator: Wolfgang Senker, MD General Hospital Amstetten
  More Information

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
First Submitted: December 14, 2010
First Posted: December 15, 2010
Last Update Posted: September 22, 2017
Last Verified: September 2017