Degenerative Lumbar DiseaseNCT01259960
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation
An observational study of Degenerative Lumbar Disease, run by Dr. Wolfgang Senker at 1 site in Austria.
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)… 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
- 187 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2011to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation.
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.
- Conditions
- Degenerative Lumbar Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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'. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation related complications
Measured: between operation and hospital discharge of patient
Post operative fever
Measured: between operation and hospital discharge of patient
Liquor leakage
Measured: between operation and hosital discharge of patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Wolfgang Senker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Wolfgang Senker, General Hospital Amstetten
- Investigators
- Wolfgang Senker, MD, Principal investigator, General Hospital Amstetten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259960
- Sponsor's protocol ID
- 2-Senker
- Status last verified
- Sep 2017
- First submitted
- 14 Dec 2010
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. 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. A Prospective Long-term Evaluation.
- ClinicalTrials.gov ID
- NCT01259960
- Acronym / sponsor ID
- 2-Senker
- Conditions
- Degenerative Lumbar Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Dr. Wolfgang SenkerUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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'. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will undergo minimal access surgical technige for degenerative lumbar disease fusion
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
Operation related complications
Time frame: between operation and hospital discharge of patient
Post operative fever
Time frame: between operation and hospital discharge of patient
Liquor leakage
Time frame: between operation and hosital discharge of patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
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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 Dr. Wolfgang Senker 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?
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 25 Sep 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Operation related complications (time frame: between operation and hospital discharge of patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017.