Degenerative Lumbar DiseaseNCT01195584

Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease

An observational study of Degenerative Lumbar Disease, run by General Hospital Amstetten at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present the observation of all cumulated patients operated with MAST. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Lumbar Disease
How many people: 72 participants
Where: 1 siteAustria
Study dates: May 2010to Jul 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery.

Who may be able to join

all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery
patient older than 18 years
all products have been used within intended use

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Austria1 site

General Hospital Amstetten
Amstetten, 3300

Other trials in Austria

About this study

The study data will include the general health information of the subjects prior to surgery, information on the surgery such as OP time, blood loss, and the postoperative wound healing process (until discharge), which is on average the 10th postoperative day.

Conditions: Degenerative Lumbar Disease
Keywords: complication rate in 3 cohorts (BMI < 25, > 25 and > 30)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01195584
Study group	Role	What they receive
BMI < 25		Body Mass Index (WHO) established by WHO. BMI < 25 has been defined as 'normal weight'.
25 >= BMI < 30		Body Mass Index (WHO) established by WHO. BMI >= 25 and < 30 has been defined as 'overweight'.
BMI >= 30		Body Mass Index (WHO) established by WHO. BMI > 30 has been defined as 'obese'.

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative Complications in the BMI Groups During Post Operative Hospitalization.
Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.
Measured: at hospital discharge

Secondary outcomes (5)

Operation Duration
Duration of the operation in minutes.
Measured: after surgery
Blood Loss
Loss of blood during surgical procedure in milliliters.
Measured: after surgery
Number of Spine Segments
Number of affected spine segments. One spine segment is defined as 2 vertebral bodies and the intervertebral disc (between the 2 vertebral bodies). For this study the number fo affected spine segments is identical to the number of operated intervertebral discs.
Measured: peri operative
Drainage
Drainage during hospitalization. The drainage was placed during the surgery and has been removed prior to hospital discharge. The amount of drainage in milliliters has been measured.
Measured: at hospital discharge
Days of Hospitalization
Total time of hospitalization.
Measured: at hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jul 2010

First posted6 Sep 2010 (estimated)
Study startMay 2010
Primary completionJul 2010
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Lumbar DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01195584
Sponsor's protocol ID: 1-Senker
Status last verified: Mar 2015
First submitted: 3 Sep 2010
Last updated: 3 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis

All Degenerative Lumbar Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease
ClinicalTrials.gov ID: NCT01195584
Acronym / sponsor ID: 1-Senker
Conditions: Degenerative Lumbar Disease
Keywords: complication rate in 3 cohorts (BMI < 25, > 25 and > 30)
Study type: Observational
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: General Hospital AmstettenUniversity, hospital or other
Study start: May 2010
Primary completion: Jul 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 6 Sep 2010 (estimated)
Results: Posted 21 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
BMI < 25	–	–Body Mass Index (WHO) established by WHO. BMI < 25 has been defined as 'normal weight'.
25 >= BMI < 30	–	–Body Mass Index (WHO) established by WHO. BMI >= 25 and < 30 has been defined as 'overweight'.
BMI >= 30	–	–Body Mass Index (WHO) established by WHO. BMI > 30 has been defined as 'obese'.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery.

Key inclusion criteria (3 listed)

all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery
patient older than 18 years
all products have been used within intended use

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Postoperative Complications in the BMI Groups During Post Operative Hospitalization.
Time frame: at hospital discharge
Postoperative complications related to the operation within the body mass index groups. A complication is any harmful event occuring during the surgery until hospital discharge.

5 secondary outcomes

Operation Duration
Time frame: after surgery
Blood Loss
Time frame: after surgery
Number of Spine Segments
Time frame: peri operative
Drainage
Time frame: at hospital discharge
Days of Hospitalization
Time frame: at hospital discharge

Results and safety

Results posted to the registry on 21 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BMI < 25	20	20
25 <= BMI < 30	25	25
BMI >= 30	27	27

Primary outcome: Postoperative Complications in the BMI Groups During Post Operative Hospitalization.

Time frame: at hospital discharge. Number. Unit: Events during hospitalization

Measure	Complications n = 72
BMI < 25	8
25 >= BMI < 30	9
BMI >= 30	20

Population analysed: Analysis per protocol

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Events have been recorded at hospital discharge for each patient. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMI < 25	0 of 20 (0%)	8 of 20 (40%)	Not reported
25 <= BMI < 30	0 of 25 (0%)	9 of 25 (36%)	Not reported
BMI >= 30	0 of 27 (0%)	20 of 27 (74.1%)	Not reported

Limitations and caveats (from the sponsor): The study is retrospective and all patients during the timeframe (who signed the patient informed consent) have been included into the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Degenerative Lumbar Disease

Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wolfgang Senker, MD principal investigator

General Hospital Amstetten

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Lumbar Disease, run by General Hospital Amstetten at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Complications in the BMI Groups During Post Operative Hospitalization. (time frame: at hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01195584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2015.