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

Degenerative Lumbar Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259960
• Other study ID #: 2-Senker
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: September 21, 2017
• Start date: February 2011
• Est. completion date: February 2017

Study information

• Verified date: September 2017
• Source: General Hospital Amstetten
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Degenerative Lumbar Disease

Locations

Country	Name	City	State
Austria	General Hospital	Amstetten

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Wolfgang Senker

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operation related complications		between operation and hospital discharge of patient
Primary	Post operative fever		between operation and hospital discharge of patient
Primary	Liquor leakage		between operation and hosital discharge of patient