NCT01259960

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

6 years

First QC Date

December 14, 2010

Last Update Submit

September 21, 2017

Conditions

Degenerative Lumbar Disease

Outcome Measures

Primary Outcomes (3)

  • Operation related complications

    between operation and hospital discharge of patient

  • Post operative fever

    between operation and hospital discharge of patient

  • Liquor leakage

    between operation and hosital discharge of patient

Study Arms (3)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who will undergo minimal access surgical technige for degenerative lumbar disease fusion

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

General Hospital

Amstetten, Austria

Location

Study Officials

  • Wolfgang Senker, MD

    General Hospital Amstetten

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Consultant for orthopedy and orthopedic surgery

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 15, 2010

Study Start

February 1, 2011

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

AU(1)