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:
Dr. Wolfgang Senker
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 16, 2013