TraumaNCT01495143
Surgical Stress Measured by Microdialysis
A study testing Posterolateral lumbar fusion surgery in people with Trauma, run by Northern Orthopaedic Division, Denmark.
Trial summary
Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma
- What is being tested?
- Posterolateral lumbar fusion surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to Jun 2008
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients who undergo conventional instrumented posterolateral lumbar fusion.
Who cannot join
- previous fusion
- chronic metabolic disease
- tumor or metastasis
- postoperative surgical complications and complications during surgery
About this study
Official title: Microdialysis of Paraspinal Muscle in Healthy Volunteers and Patients Underwent Posterior Lumbar Fusion Surgery
Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).
Read the detailed description
Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.
- Conditions
- Trauma
- Being tested
- Posterolateral lumbar fusion surgery
- Keywords
- Glucose, Lactate pyruvate ratio, Glycerol, Paraspinal muscle, Microdialysis
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterolateral lumbar fusion surgeryProcedure or surgery
Also called Lumbar diseases
Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Active comparator | Eight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated. Receives: Procedure: Posterolateral lumbar fusion surgery |
| Surgery group | Experimental | Two MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally.
A reference catheter is placed in the deltoid muscle. Receives: Procedure: Posterolateral lumbar fusion surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The glycerol concentration
To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gang Ren, MD, PhD, Principal investigator, Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495143
- Sponsor's protocol ID
- ON-07-012-RAS
- Status last verified
- Sep 2014
- First submitted
- 29 Dec 2009
- Last updated
- 15 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microdialysis of Paraspinal Muscle in Healthy Volunteers and Patients Underwent Posterior Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT01495143
- Acronym / sponsor ID
- ON-07-012-RAS
- Conditions
- Trauma
- Keywords
- Glucose, Lactate pyruvate ratio, Glycerol, Paraspinal muscle, Microdialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Dec 2011 (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.
Paraspinal muscle damage is inevitable during conventional posterior lumbar fusion surgery. Minimal invasive surgery is postulated to result in less muscle damage and better outcome. The aim of this study is to monitor metabolic changes of the paraspinal muscle and to evaluate paraspinal muscle damage during surgery using microdialysis (MD).
Detailed description
Posterior approach is a common and important surgical procedure for various lumbar diseases. Owing to the anatomy, the damage of paraspinal muscle is inevitable during conventional posterior lumbar fusion surgery. Degeneration and malfunction of the paraspinal muscle might associate with pain and inferior postoperative clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy group | Active comparator | Procedure: Posterolateral lumbar fusion surgeryEight healthy volunteers (five males and three females) with a body mass index of 23.8 and without chronic metabolic disease or low back pain. They are all non-smokers and non-medicated. |
| Surgery group | Experimental | Procedure: Posterolateral lumbar fusion surgeryTwo MD catheters is placed in the paraspinal muscle at the level of midpoint of incision bilaterally. A reference catheter is placed in the deltoid muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who undergo conventional instrumented posterolateral lumbar fusion.
Key exclusion criteria (4 listed)
- previous fusion
- chronic metabolic disease
- tumor or metastasis
- postoperative surgical complications and complications during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterolateral lumbar fusion surgeryAlso: Lumbar diseasesTwo MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle. | Procedure or surgery | Healthy group, Surgery group |
Primary outcome
The glycerol concentration
Time frame: Two hours
To study whether the glucerol concentration can be used to evaluate surgery related paraspinal muscle damage
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 15 Sep 2014.
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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.
Gang Ren, MD, PhD principal investigator
Orthopaedic Division, North Denmark Region, Aalborg University Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Posterolateral lumbar fusion surgery in people with Trauma, run by Northern Orthopaedic Division, Denmark.
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 1 inclusion and 4 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 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The glycerol concentration (time frame: Two hours). 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 15 Sep 2014.