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

NCT ID: NCT01259960

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Lumbar Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BMI < 25

Body Mass Index (BMI) according to WHO definition. BMI \< 25 is defined as 'normal weight'.

No interventions assigned to this group

25 <= BMI < 30

Body Mass Index (BMI) according to WHO definition. BMI \>= 25 and \< 30 is defined as 'overweight'.

No interventions assigned to this group

BMI >= 30

Body Mass Index (BMI) according to WHO definition. BMI \>= 30 is defined as 'obese'.

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Wolfgang Senker

OTHER

Sponsor Role lead

Responsible Party

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Dr. Wolfgang Senker

Senior Consultant for orthopedy and orthopedic surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wolfgang Senker, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Amstetten

Locations

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General Hospital

Amstetten, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2-Senker

Identifier Type: -

Identifier Source: org_study_id