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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 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: March 16, 2015
Last verified: March 2015
  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 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
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: March 16, 2015
Health Authority: Austria: Ethikkommission

ClinicalTrials.gov processed this record on September 23, 2016